Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
Purpose
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy versus (vs.) standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients.
Conditions
- B Acute Lymphoblastic Leukemia
- B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
- B Acute Lymphoblastic Leukemia, BCR-ABL1-Like
- Lymphoblastic Lymphoma
- Mixed Phenotype Acute Leukemia
- T Acute Lymphoblastic Leukemia
Eligibility
- Eligible Ages
- Between 15 Years and 40 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- >= 15 and < 40 years at time of diagnosis - Newly diagnosed B-ALL, T-ALL, lymphoblastic lymphoma (LLy), or mixed-phenotype acute leukemia/lymphoma (MPAL) - Note: Philadelphia chromosome (PH)+ and PH-like acute leukemia are eligible (use of tyrosine kinase inhibitors [TKI] or CRLF2- targeted concomitant medication must be documented, if used) - Conjugated bilirubin =< 1.5 x upper limit of normal (ULN) for age, regardless of baseline bilirubin (within 7 days prior to enrollment), and - Serum glutamate pyruvate transaminase (SGPT) (ALT) =< 225 U/L (=< 5x ULN) (within 7 days prior to enrollment), and - Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and serum glutamic oxaloacetic transaminase (SGOT) (AST) to 50 U/L regardless of baseline - SGOT (AST) =< 250 U/L (=< 5x ULN) (within 7 days prior to enrollment) - Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and SGOT (AST) to 50 U/L regardless of baseline - For patients receiving ursodiol prior to enrollment, laboratory values must meet above criteria off ursodiol for 7 days - PEDIATRIC PATIENTS (AGE 15-17 years): - A 24-hour urine creatinine clearance >= 30 mL/min/1.73 m^2 (within 7 days prior to enrollment) OR - A glomerular filtration rate (GFR) >= 30 mL/min/1.73 m^2. GFR must be performed using one of the following methods (within 7 days prior to enrollment): - 1. Estimated GFR (eGFR) >= 30 mL/min/1.73 m^2. - An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr_calculatorped - 2. Measured GFR >= 30 mL/min/1.73 m^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard). - ADULT PATIENTS (AGE 18 YEARS OR OLDER): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection (within 7 days prior to enrollment). Estimated creatinine clearance is based on actual body weight - An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr_calculatorcoc - Berlin-Frankfurt-Munich (BFM), Children's Oncology Group (COG), or C10403-based Induction regimen and must be inclusive of >= 1 dose of pegaspargase or calaspargase pegol, and - First dose of asparaginase must be planned within the first week of induction therapy, and - Dose of pegaspargase or calaspargase pegol must be >= 1,000 IU/ m^2 (dose-capping permitted per primary regimen) - Note: Co-enrollment on a therapeutic consortia trial is not required - All patients and/or their parents or legal guardians must sign a written informed consent - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria
- Down syndrome - Known inherited or autoimmune liver disease impacting conjugated bilirubin (e.g., Alagille syndrome, primary sclerosing cholangitis, other) - Known biopsy (or imaging) proven severe liver fibrosis (Batts-Ludwig >= stage 3) - Unable to tolerate oral formulation of study drug at enrollment - Patients who received chemotherapy or treatment for a prior malignancy are not eligible - The following are permitted: steroid prophase, hydroxyurea, or other cytoreduction prior to initiation of Induction chemotherapy (must be documented) and chemotherapy for current diagnosis (i.e. initiation of Induction therapy within enrollment window). Chemotherapy prior to enrollment for treatment of a non-malignancy (e.g., steroid or methotrexate for autoimmune disease) is also permitted and must be documented - Female patients who are pregnant since fetal toxicities and teratogenic effects in humans are unknown for study drug. A pregnancy test is required for female patients of childbearing potential - Lactating females who plan to breastfeed their infants - Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Parallel with the option to cross over to Arm C to begin levocarnitine rescue
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A (levocarnitine, standard of care chemotherapy) |
Patients receive levocarnitine PO or IV as a bolus over 2 to 3 minutes or by infusion (over 10 to 30 minutes or per institutional standard) starting prior to standard of care induction chemotherapy with pegaspargase or calaspargase pegol and continued through the earlier of the last day of Induction phase (i.e., day prior to start of next phase) or Induction day 35. Patients may also undergo blood sample collection during screening and on study. |
|
|
Active Comparator Arm B (standard of care chemotherapy) |
Patients receive standard of care induction chemotherapy with pegaspargase or calaspargase pegol on study. Patients may also undergo blood sample collection during screening and on study. |
|
|
Experimental Arm C (rescue levocarnitine) |
Patients in Arms A and B who develop conjugated hyperbilirubinemia > 3 mg/dL during induction may receive levocarnitine rescue PO or IV as a bolus dose over 2 to 3 minutes or by infusion (over 10 to 30 minutes or per institutional standard) until resolution of conjugated hyperbilirubinemia =< 3 mg/dL (or start of consolidation or the next treatment phase, whichever occurs first). |
|
Recruiting Locations
Children's Hospital of Alabama
Birmingham 4049979, Alabama 4829764 35233
Birmingham 4049979, Alabama 4829764 35233
Providence Alaska Medical Center
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Kingman Regional Medical Center
Kingman 5301067, Arizona 5551752 86401
Kingman 5301067, Arizona 5551752 86401
Phoenix Childrens Hospital
Phoenix 5308655, Arizona 5551752 85016
Phoenix 5308655, Arizona 5551752 85016
Contact:
Site Public Contact
602-546-0920
Site Public Contact
602-546-0920
Banner University Medical Center - Tucson
Tucson 5318313, Arizona 5551752 85719
Tucson 5318313, Arizona 5551752 85719
Arkansas Children's Hospital
Little Rock 4119403, Arkansas 4099753 72202-3591
Little Rock 4119403, Arkansas 4099753 72202-3591
Contact:
Site Public Contact
501-364-7373
Site Public Contact
501-364-7373
Kaiser Permanente-Anaheim
Anaheim 5323810, California 5332921 92806
Anaheim 5323810, California 5332921 92806
PCR Oncology
Arroyo Grande 5324802, California 5332921 93420
Arroyo Grande 5324802, California 5332921 93420
Kaiser Permanente-Bellflower
Bellflower 5327422, California 5332921 90706
Bellflower 5327422, California 5332921 90706
Kaiser Permanente Downey Medical Center
Downey 5343858, California 5332921 90242
Downey 5343858, California 5332921 90242
Contact:
Site Public Contact
626-564-3455
Site Public Contact
626-564-3455
City of Hope Comprehensive Cancer Center
Duarte 5344147, California 5332921 91010
Duarte 5344147, California 5332921 91010
Kaiser Permanente-Fontana
Fontana 5349755, California 5332921 92335
Fontana 5349755, California 5332921 92335
Loma Linda University Medical Center
Loma Linda 5367696, California 5332921 92354
Loma Linda 5367696, California 5332921 92354
Contact:
Site Public Contact
909-558-4050
Site Public Contact
909-558-4050
Miller Children's and Women's Hospital Long Beach
Long Beach 5367929, California 5332921 90806
Long Beach 5367929, California 5332921 90806
Contact:
Site Public Contact
562-933-5600
Site Public Contact
562-933-5600
Children's Hospital Los Angeles
Los Angeles 5368361, California 5332921 90027
Los Angeles 5368361, California 5332921 90027
Contact:
Site Public Contact
323-361-4110
Site Public Contact
323-361-4110
Kaiser Permanente Los Angeles Medical Center
Los Angeles 5368361, California 5332921 90027
Los Angeles 5368361, California 5332921 90027
Valley Children's Hospital
Madera 5369568, California 5332921 93636
Madera 5369568, California 5332921 93636
UCSF Benioff Children's Hospital Oakland
Oakland 5378538, California 5332921 94609
Oakland 5378538, California 5332921 94609
Lucile Packard Children's Hospital Stanford University
Palo Alto 5380748, California 5332921 94304
Palo Alto 5380748, California 5332921 94304
Stanford Cancer Institute Palo Alto
Palo Alto 5380748, California 5332921 94304
Palo Alto 5380748, California 5332921 94304
Sutter Medical Center Sacramento
Sacramento 5389489, California 5332921 95816
Sacramento 5389489, California 5332921 95816
University of California Davis Comprehensive Cancer Center
Sacramento 5389489, California 5332921 95817
Sacramento 5389489, California 5332921 95817
Contact:
Site Public Contact
916-734-3089
Site Public Contact
916-734-3089
Kaiser Permanente-San Diego Mission
San Diego 5391811, California 5332921 92108
San Diego 5391811, California 5332921 92108
Kaiser Permanente-San Diego Zion
San Diego 5391811, California 5332921 92120
San Diego 5391811, California 5332921 92120
UCSF Medical Center-Mission Bay
San Francisco 5391959, California 5332921 94158
San Francisco 5391959, California 5332921 94158
Children's Hospital Colorado
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver 5419384, Colorado 5417618 80218
Denver 5419384, Colorado 5417618 80218
Alfred I duPont Hospital for Children
Wilmington 4145381, Delaware 4142224 19803
Wilmington 4145381, Delaware 4142224 19803
Children's National Medical Center
Washington D.C. 4140963, District of Columbia 4138106 20010
Washington D.C. 4140963, District of Columbia 4138106 20010
Golisano Children's Hospital of Southwest Florida
Fort Myers 4155995, Florida 4155751 33908
Fort Myers 4155995, Florida 4155751 33908
UF Health Cancer Institute - Gainesville
Gainesville 4156404, Florida 4155751 32610
Gainesville 4156404, Florida 4155751 32610
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood 4158928, Florida 4155751 33021
Hollywood 4158928, Florida 4155751 33021
Nemours Children's Clinic-Jacksonville
Jacksonville 4160021, Florida 4155751 32207
Jacksonville 4160021, Florida 4155751 32207
Nicklaus Children's Hospital
Miami 4164138, Florida 4155751 33155
Miami 4164138, Florida 4155751 33155
Contact:
Site Public Contact
888-624-2778
Site Public Contact
888-624-2778
Miami Cancer Institute
Miami 4164138, Florida 4155751 33176
Miami 4164138, Florida 4155751 33176
Contact:
Site Public Contact
786-596-2000
Site Public Contact
786-596-2000
AdventHealth Orlando
Orlando 4167147, Florida 4155751 32803
Orlando 4167147, Florida 4155751 32803
Nemours Children's Hospital
Orlando 4167147, Florida 4155751 32827
Orlando 4167147, Florida 4155751 32827
Nemours Children's Clinic - Pensacola
Pensacola 4168228, Florida 4155751 32504
Pensacola 4168228, Florida 4155751 32504
Johns Hopkins All Children's Hospital
St. Petersburg 4171563, Florida 4155751 33701
St. Petersburg 4171563, Florida 4155751 33701
Tampa General Hospital
Tampa 4174757, Florida 4155751 33606
Tampa 4174757, Florida 4155751 33606
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa 4174757, Florida 4155751 33607
Tampa 4174757, Florida 4155751 33607
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta 4180439, Georgia 4197000 30329
Atlanta 4180439, Georgia 4197000 30329
Memorial Health University Medical Center
Savannah 4221552, Georgia 4197000 31404
Savannah 4221552, Georgia 4197000 31404
Kapiolani Medical Center for Women and Children
Honolulu 5856195, Hawaii 5855797 96826
Honolulu 5856195, Hawaii 5855797 96826
Contact:
Site Public Contact
808-983-6090
Site Public Contact
808-983-6090
Saint Luke's Cancer Institute - Boise
Boise 5586437, Idaho 5596512 83712
Boise 5586437, Idaho 5596512 83712
Saint Luke's Cancer Institute - Fruitland
Fruitland 5593708, Idaho 5596512 83619
Fruitland 5593708, Idaho 5596512 83619
Saint Luke's Cancer Institute - Meridian
Meridian 5600685, Idaho 5596512 83642
Meridian 5600685, Idaho 5596512 83642
Saint Luke's Cancer Institute - Nampa
Nampa 5601933, Idaho 5596512 83687
Nampa 5601933, Idaho 5596512 83687
Saint Luke's Cancer Institute - Twin Falls
Twin Falls 5610810, Idaho 5596512 83301
Twin Falls 5610810, Idaho 5596512 83301
Northwestern University
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
University of Illinois
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60612
Contact:
Site Public Contact
312-355-3046
Site Public Contact
312-355-3046
University of Chicago Comprehensive Cancer Center
Chicago 4887398, Illinois 4896861 60637
Chicago 4887398, Illinois 4896861 60637
Advocate Children's Hospital-Oak Lawn
Oak Lawn 4904365, Illinois 4896861 60453
Oak Lawn 4904365, Illinois 4896861 60453
Contact:
Site Public Contact
847-723-7570
Site Public Contact
847-723-7570
Advocate Children's Hospital-Park Ridge
Park Ridge 4905367, Illinois 4896861 60068
Park Ridge 4905367, Illinois 4896861 60068
Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861 62702
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Riley Hospital for Children
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Site Public Contact
800-248-1199
Site Public Contact
800-248-1199
Ascension Saint Vincent Indianapolis Hospital
Indianapolis 4259418, Indiana 4921868 46260
Indianapolis 4259418, Indiana 4921868 46260
Blank Children's Hospital
Des Moines 4853828, Iowa 4862182 50309
Des Moines 4853828, Iowa 4862182 50309
University of Iowa/Holden Comprehensive Cancer Center
Iowa City 4862034, Iowa 4862182 52242
Iowa City 4862034, Iowa 4862182 52242
Contact:
Site Public Contact
800-237-1225
Site Public Contact
800-237-1225
University of Kansas Cancer Center
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
University of Kansas Hospital-Westwood Cancer Center
Westwood 4281639, Kansas 4273857 66205
Westwood 4281639, Kansas 4273857 66205
University of Kentucky/Markey Cancer Center
Lexington 4297983, Kentucky 6254925 40536
Lexington 4297983, Kentucky 6254925 40536
Contact:
Site Public Contact
859-257-3379
Site Public Contact
859-257-3379
Norton Children's Hospital
Louisville 4299276, Kentucky 6254925 40202
Louisville 4299276, Kentucky 6254925 40202
Children's Hospital New Orleans
New Orleans 4335045, Louisiana 4331987 70118
New Orleans 4335045, Louisiana 4331987 70118
Contact:
Site Public Contact
504-894-5377
Site Public Contact
504-894-5377
Ochsner Medical Center Jefferson
New Orleans 4335045, Louisiana 4331987 70121
New Orleans 4335045, Louisiana 4331987 70121
Maine Children's Cancer Program
Scarborough 4977882, Maine 4971068 04074
Scarborough 4977882, Maine 4971068 04074
Sinai Hospital of Baltimore
Baltimore 4347778, Maryland 4361885 21215
Baltimore 4347778, Maryland 4361885 21215
Contact:
Site Public Contact
410-601-9083
Site Public Contact
410-601-9083
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore 4347778, Maryland 4361885 21287
Baltimore 4347778, Maryland 4361885 21287
C S Mott Children's Hospital
Ann Arbor 4984247, Michigan 5001836 48109
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Site Public Contact
800-865-1125
Site Public Contact
800-865-1125
University of Michigan Comprehensive Cancer Center
Ann Arbor 4984247, Michigan 5001836 48109
Ann Arbor 4984247, Michigan 5001836 48109
Bronson Battle Creek
Battle Creek 4985153, Michigan 5001836 49017
Battle Creek 4985153, Michigan 5001836 49017
Children's Hospital of Michigan
Detroit 4990729, Michigan 5001836 48201
Detroit 4990729, Michigan 5001836 48201
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Trinity Health Grand Rapids Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Bronson Methodist Hospital
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49007
West Michigan Cancer Center
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49007
Beacon Kalamazoo Cancer Center
Kalamazoo 4997787, Michigan 5001836 49009
Kalamazoo 4997787, Michigan 5001836 49009
Contact:
Site Public Contact
574-647-7370
Site Public Contact
574-647-7370
Beacon Kalamazoo
Kalamazoo 4997787, Michigan 5001836 49048
Kalamazoo 4997787, Michigan 5001836 49048
Contact:
Site Public Contact
574-647-7370
Site Public Contact
574-647-7370
Trinity Health Muskegon Hospital
Muskegon 5003132, Michigan 5001836 49444
Muskegon 5003132, Michigan 5001836 49444
Corewell Health Lakeland Hospitals - Niles Hospital
Niles 5003514, Michigan 5001836 49120
Niles 5003514, Michigan 5001836 49120
Contact:
Site Public Contact
616-391-1230
Site Public Contact
616-391-1230
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores 5004005, Michigan 5001836 49444
Norton Shores 5004005, Michigan 5001836 49444
Corewell Health Reed City Hospital
Reed City 5006946, Michigan 5001836 49677
Reed City 5006946, Michigan 5001836 49677
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph 5008327, Michigan 5001836 49085
Saint Joseph 5008327, Michigan 5001836 49085
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph 5008327, Michigan 5001836 49085
Saint Joseph 5008327, Michigan 5001836 49085
Munson Medical Center
Traverse City 5012495, Michigan 5001836 49684
Traverse City 5012495, Michigan 5001836 49684
University of Michigan Health - West
Wyoming 5015618, Michigan 5001836 49519
Wyoming 5015618, Michigan 5001836 49519
Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216
Jackson 4431410, Mississippi 4436296 39216
Contact:
Site Public Contact
601-815-6700
Site Public Contact
601-815-6700
Children's Mercy Hospitals and Clinics
Kansas City 4393217, Missouri 4398678 64108
Kansas City 4393217, Missouri 4398678 64108
Mercy Hospital Saint Louis
St Louis 4407066, Missouri 4398678 63141
St Louis 4407066, Missouri 4398678 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Children's Hospital and Medical Center of Omaha
Omaha 5074472, Nebraska 5073708 68114
Omaha 5074472, Nebraska 5073708 68114
Contact:
Site Public Contact
402-955-3949
Site Public Contact
402-955-3949
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
Omaha 5074472, Nebraska 5073708 68198
Carson Tahoe Regional Medical Center
Carson City 5501344, Nevada 5509151 89703
Carson City 5501344, Nevada 5509151 89703
Comprehensive Cancer Centers of Nevada - Henderson
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
OptumCare Cancer Care at Seven Hills
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Las Vegas Urology - Green Valley
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Las Vegas Urology - Pebble
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Oncology Las Vegas - Henderson
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Urology Specialists of Nevada - Green Valley
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Las Vegas Urology - Pecos
Las Vegas 5506956, Nevada 5509151 89074
Las Vegas 5506956, Nevada 5509151 89074
OptumCare Cancer Care at Charleston
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas 5506956, Nevada 5509151 89102
University Medical Center of Southern Nevada
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas 5506956, Nevada 5509151 89102
Hope Cancer Care of Nevada
Las Vegas 5506956, Nevada 5509151 89103
Las Vegas 5506956, Nevada 5509151 89103
Radiation Oncology Centers of Nevada Central
Las Vegas 5506956, Nevada 5509151 89106
Las Vegas 5506956, Nevada 5509151 89106
Urology Specialists of Nevada - Central
Las Vegas 5506956, Nevada 5509151 89106
Las Vegas 5506956, Nevada 5509151 89106
Sunrise Hospital and Medical Center
Las Vegas 5506956, Nevada 5509151 89109
Las Vegas 5506956, Nevada 5509151 89109
Las Vegas Urology - Sunset
Las Vegas 5506956, Nevada 5509151 89113
Las Vegas 5506956, Nevada 5509151 89113
Urology Specialists of Nevada - Southwest
Las Vegas 5506956, Nevada 5509151 89113
Las Vegas 5506956, Nevada 5509151 89113
Radiation Oncology Centers of Nevada Southeast
Las Vegas 5506956, Nevada 5509151 89119
Las Vegas 5506956, Nevada 5509151 89119
Ann M Wierman MD LTD
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas Urology - Cathedral Rock
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas Urology - Smoke Ranch
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Oncology Las Vegas - Tenaya
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
OptumCare Cancer Care at MountainView
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Urology Specialists of Nevada - Northwest
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas 5506956, Nevada 5509151 89135
Las Vegas 5506956, Nevada 5509151 89135
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas 5506956, Nevada 5509151 89144
Las Vegas 5506956, Nevada 5509151 89144
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas 5506956, Nevada 5509151 89144
Las Vegas 5506956, Nevada 5509151 89144
Summerlin Hospital Medical Center
Las Vegas 5506956, Nevada 5509151 89144
Las Vegas 5506956, Nevada 5509151 89144
Comprehensive Cancer Centers of Nevada
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89148
OptumCare Cancer Care at Fort Apache
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89148
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas 5506956, Nevada 5509151 89169
Las Vegas 5506956, Nevada 5509151 89169
Hope Cancer Care of Nevada-Pahrump
Pahrump 5509851, Nevada 5509151 89048
Pahrump 5509851, Nevada 5509151 89048
Renown Regional Medical Center
Reno 5511077, Nevada 5509151 89502
Reno 5511077, Nevada 5509151 89502
Saint Mary's Regional Medical Center
Reno 5511077, Nevada 5509151 89503
Reno 5511077, Nevada 5509151 89503
Radiation Oncology Associates
Reno 5511077, Nevada 5509151 89509
Reno 5511077, Nevada 5509151 89509
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
Hackensack 5098706, New Jersey 5101760 07601
Contact:
Site Public Contact
551-996-2897
Site Public Contact
551-996-2897
Jersey Shore Medical Center
Neptune City 5101687, New Jersey 5101760 07753
Neptune City 5101687, New Jersey 5101760 07753
Contact:
Site Public Contact
732-776-4240
Site Public Contact
732-776-4240
Newark Beth Israel Medical Center
Newark 5101798, New Jersey 5101760 07112
Newark 5101798, New Jersey 5101760 07112
Saint Joseph's Regional Medical Center
Paterson 5102466, New Jersey 5101760 07503
Paterson 5102466, New Jersey 5101760 07503
Presbyterian Hospital
Albuquerque 5454711, New Mexico 5481136 87106
Albuquerque 5454711, New Mexico 5481136 87106
University of New Mexico Cancer Center
Albuquerque 5454711, New Mexico 5481136 87106
Albuquerque 5454711, New Mexico 5481136 87106
Albany Medical Center
Albany 5106834, New York 5128638 12208
Albany 5106834, New York 5128638 12208
Contact:
Site Public Contact
518-262-5513
Site Public Contact
518-262-5513
NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638 11501
Mineola 5127134, New York 5128638 11501
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park 5128514, New York 5128638 11040
New Hyde Park 5128514, New York 5128638 11040
Contact:
Site Public Contact
718-470-3460
Site Public Contact
718-470-3460
NYP/Weill Cornell Medical Center
New York 5128581, New York 5128638 10065
New York 5128581, New York 5128638 10065
Contact:
Site Public Contact
212-746-1848
Site Public Contact
212-746-1848
Stony Brook University Medical Center
Stony Brook 5139865, New York 5128638 11794
Stony Brook 5139865, New York 5128638 11794
Contact:
Site Public Contact
800-862-2215
Site Public Contact
800-862-2215
Montefiore Medical Center-Einstein Campus
The Bronx 5110266, New York 5128638 10461
The Bronx 5110266, New York 5128638 10461
Montefiore Medical Center-Weiler Hospital
The Bronx 5110266, New York 5128638 10461
The Bronx 5110266, New York 5128638 10461
Children's Hospital at Montefiore
The Bronx 5110266, New York 5128638 10467
The Bronx 5110266, New York 5128638 10467
Montefiore Medical Center - Moses Campus
The Bronx 5110266, New York 5128638 10467
The Bronx 5110266, New York 5128638 10467
New York Medical College
Valhalla 5142090, New York 5128638 10595
Valhalla 5142090, New York 5128638 10595
Contact:
Site Public Contact
914-594-3794
Site Public Contact
914-594-3794
UNC Lineberger Comprehensive Cancer Center
Chapel Hill 4460162, North Carolina 4482348 27599
Chapel Hill 4460162, North Carolina 4482348 27599
Carolinas Medical Center/Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348 28203
Charlotte 4460243, North Carolina 4482348 28203
Contact:
Site Public Contact
800-804-9376
Site Public Contact
800-804-9376
Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348 27157
Winston-Salem 4499612, North Carolina 4482348 27157
Contact:
Site Public Contact
336-713-6771
Site Public Contact
336-713-6771
Sanford Broadway Medical Center
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
Children's Hospital Medical Center of Akron
Akron 5145476, Ohio 5165418 44308
Akron 5145476, Ohio 5165418 44308
Contact:
Site Public Contact
330-543-3193
Site Public Contact
330-543-3193
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229
Cincinnati 4508722, Ohio 5165418 45229
Rainbow Babies and Childrens Hospital
Cleveland 5150529, Ohio 5165418 44106
Cleveland 5150529, Ohio 5165418 44106
Contact:
Site Public Contact
216-844-5437
Site Public Contact
216-844-5437
Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
Cleveland 5150529, Ohio 5165418 44195
Nationwide Children's Hospital
Columbus 4509177, Ohio 5165418 43205
Columbus 4509177, Ohio 5165418 43205
Dayton Children's Hospital
Dayton 4509884, Ohio 5165418 45404
Dayton 4509884, Ohio 5165418 45404
Contact:
Site Public Contact
800-228-4055
Site Public Contact
800-228-4055
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo 5174035, Ohio 5165418 43606
Toledo 5174035, Ohio 5165418 43606
University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73104
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa 4553433, Oklahoma 4544379 74136
Tulsa 4553433, Oklahoma 4544379 74136
Contact:
Site Public Contact
918-494-2200
Site Public Contact
918-494-2200
Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239
Portland 5746545, Oregon 5744337 97239
Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927 17822
Danville 5186327, Pennsylvania 6254927 17822
Penn State Children's Hospital
Hershey 5193342, Pennsylvania 6254927 17033
Hershey 5193342, Pennsylvania 6254927 17033
Contact:
Site Public Contact
717-531-6012
Site Public Contact
717-531-6012
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh 5206379, Pennsylvania 6254927 15224
Pittsburgh 5206379, Pennsylvania 6254927 15224
Saint Francis Hospital
Greenville 4580543, South Carolina 4597040 29601
Greenville 4580543, South Carolina 4597040 29601
BI-LO Charities Children's Cancer Center
Greenville 4580543, South Carolina 4597040 29605
Greenville 4580543, South Carolina 4597040 29605
Prisma Health Greenville Memorial Hospital
Greenville 4580543, South Carolina 4597040 29605
Greenville 4580543, South Carolina 4597040 29605
Saint Francis Cancer Center
Greenville 4580543, South Carolina 4597040 29607
Greenville 4580543, South Carolina 4597040 29607
Prisma Health Cancer Institute - Eastside
Greenville 4580543, South Carolina 4597040 29615
Greenville 4580543, South Carolina 4597040 29615
Sanford USD Medical Center - Sioux Falls
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Sioux Falls 5231851, South Dakota 5769223 57117-5134
East Tennessee Childrens Hospital
Knoxville 4634946, Tennessee 4662168 37916
Knoxville 4634946, Tennessee 4662168 37916
Contact:
Site Public Contact
865-541-8266
Site Public Contact
865-541-8266
The Children's Hospital at TriStar Centennial
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
Contact:
Site Public Contact
615-342-1919
Site Public Contact
615-342-1919
Vanderbilt University/Ingram Cancer Center
Nashville 4644585, Tennessee 4662168 37232
Nashville 4644585, Tennessee 4662168 37232
Contact:
Site Public Contact
800-811-8480
Site Public Contact
800-811-8480
Dell Children's Medical Center of Central Texas
Austin 4671654, Texas 4736286 78723
Austin 4671654, Texas 4736286 78723
Driscoll Children's Hospital
Corpus Christi 4683416, Texas 4736286 78411
Corpus Christi 4683416, Texas 4736286 78411
Medical City Dallas Hospital
Dallas 4684888, Texas 4736286 75230
Dallas 4684888, Texas 4736286 75230
Contact:
Site Public Contact
972-566-5588
Site Public Contact
972-566-5588
UT Southwestern/Simmons Cancer Center-Dallas
Dallas 4684888, Texas 4736286 75390
Dallas 4684888, Texas 4736286 75390
El Paso Children's Hospital
El Paso 5520993, Texas 4736286 79905
El Paso 5520993, Texas 4736286 79905
Cook Children's Medical Center
Fort Worth 4691930, Texas 4736286 76104
Fort Worth 4691930, Texas 4736286 76104
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
M D Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Covenant Children's Hospital
Lubbock 5525577, Texas 4736286 79410
Lubbock 5525577, Texas 4736286 79410
UMC Cancer Center / UMC Health System
Lubbock 5525577, Texas 4736286 79415
Lubbock 5525577, Texas 4736286 79415
Contact:
Site Public Contact
806-775-8590
Site Public Contact
806-775-8590
Children's Hospital of San Antonio
San Antonio 4726206, Texas 4736286 78207
San Antonio 4726206, Texas 4736286 78207
Methodist Children's Hospital of South Texas
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
University of Texas Health Science Center at San Antonio
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
University of Virginia Cancer Center
Charlottesville 4752031, Virginia 6254928 22908
Charlottesville 4752031, Virginia 6254928 22908
Inova Fairfax Hospital
Falls Church 4758390, Virginia 6254928 22042
Falls Church 4758390, Virginia 6254928 22042
Children's Hospital of The King's Daughters
Norfolk 4776222, Virginia 6254928 23507
Norfolk 4776222, Virginia 6254928 23507
VCU Massey Comprehensive Cancer Center
Richmond 4781708, Virginia 6254928 23298
Richmond 4781708, Virginia 6254928 23298
Carilion Children's
Roanoke 4782167, Virginia 6254928 24014
Roanoke 4782167, Virginia 6254928 24014
Valley Medical Center
Renton 5808189, Washington 5815135 98055
Renton 5808189, Washington 5815135 98055
Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105
Seattle 5809844, Washington 5815135 98105
Contact:
Site Public Contact
866-987-2000
Site Public Contact
866-987-2000
Providence Sacred Heart Medical Center and Children's Hospital
Spokane 5811696, Washington 5815135 99204
Spokane 5811696, Washington 5815135 99204
Mary Bridge Children's Hospital and Health Center
Tacoma 5812944, Washington 5815135 98405
Tacoma 5812944, Washington 5815135 98405
Madigan Army Medical Center
Tacoma 5812944, Washington 5815135 98431
Tacoma 5812944, Washington 5815135 98431
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima 5816605, Washington 5815135 98902
Yakima 5816605, Washington 5815135 98902
Aurora Cancer Care-Southern Lakes VLCC
Burlington 5247214, Wisconsin 5279468 53105
Burlington 5247214, Wisconsin 5279468 53105
Aurora Saint Luke's South Shore
Cudahy 5249871, Wisconsin 5279468 53110
Cudahy 5249871, Wisconsin 5279468 53110
Aurora Health Care Germantown Health Center
Germantown 5254218, Wisconsin 5279468 53022
Germantown 5254218, Wisconsin 5279468 53022
Aurora Cancer Care-Grafton
Grafton 5254739, Wisconsin 5279468 53024
Grafton 5254739, Wisconsin 5279468 53024
Aurora BayCare Medical Center
Green Bay 5254962, Wisconsin 5279468 54311
Green Bay 5254962, Wisconsin 5279468 54311
Aurora Cancer Care-Kenosha South
Kenosha 5258393, Wisconsin 5279468 53142
Kenosha 5258393, Wisconsin 5279468 53142
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison 5261457, Wisconsin 5279468 53718
Madison 5261457, Wisconsin 5279468 53718
University of Wisconsin Carbone Cancer Center - University Hospital
Madison 5261457, Wisconsin 5279468 53792
Madison 5261457, Wisconsin 5279468 53792
Aurora Bay Area Medical Group-Marinette
Marinette 5261852, Wisconsin 5279468 54143
Marinette 5261852, Wisconsin 5279468 54143
Marshfield Medical Center-Marshfield
Marshfield 5261969, Wisconsin 5279468 54449
Marshfield 5261969, Wisconsin 5279468 54449
Aurora Cancer Care-Milwaukee
Milwaukee 5263045, Wisconsin 5279468 53209
Milwaukee 5263045, Wisconsin 5279468 53209
Aurora Saint Luke's Medical Center
Milwaukee 5263045, Wisconsin 5279468 53215
Milwaukee 5263045, Wisconsin 5279468 53215
Children's Hospital of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Milwaukee 5263045, Wisconsin 5279468 53226
Aurora Sinai Medical Center
Milwaukee 5263045, Wisconsin 5279468 53233
Milwaukee 5263045, Wisconsin 5279468 53233
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh 5265838, Wisconsin 5279468 54904
Oshkosh 5265838, Wisconsin 5279468 54904
Aurora Cancer Care-Racine
Racine 5268249, Wisconsin 5279468 53406
Racine 5268249, Wisconsin 5279468 53406
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan 5272893, Wisconsin 5279468 53081
Sheboygan 5272893, Wisconsin 5279468 53081
Aurora Medical Center in Summit
Summit, Wisconsin 5279468 53066
Summit, Wisconsin 5279468 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers 5276609, Wisconsin 5279468 54241
Two Rivers 5276609, Wisconsin 5279468 54241
Aurora Cancer Care-Milwaukee West
Wauwatosa 5278159, Wisconsin 5279468 53226
Wauwatosa 5278159, Wisconsin 5279468 53226
Aurora West Allis Medical Center
West Allis 5278420, Wisconsin 5279468 53227
West Allis 5278420, Wisconsin 5279468 53227
More Details
- NCT ID
- NCT05602194
- Status
- Recruiting
- Sponsor
- Children's Oncology Group
Detailed Description
PRIMARY OBJECTIVE: I. To determine in a randomized manner whether the addition of levocarnitine prophylaxis to asparaginase-containing regimens will decrease the incidence of conjugated hyperbilirubinemia (> 3 mg/dL) during ALL induction therapy for adolescents and young adults (adolescents and young adults [AYAs], age 15-39 years). SECONDARY OBJECTIVES: I. To examine the impact of levocarnitine prophylaxis on differences in the incidence of grade >= 3 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations during ALL Induction. II. To compare rates of minimal residual disease (MRD) positivity at end of Induction and describe MRD+ by end of consolidation (EOC) in those receiving ALL induction chemotherapy with and without levocarnitine. EXPLORATORY OBJECTIVES: I. To compare rates of toxicity and associated dose reductions for chemotherapy administered with and without concomitant levocarnitine supplementation. II. To compare across study arms the peak levels during Induction of conjugated and total bilirubin, AST, ALT, and duration of conjugated hyperbilirubinemia from onset > 3 mg/dL to =< 3 mg/dL. III. To describe the efficacy of levocarnitine prophylaxis to reduce the incidence and/or severity of early patient-reported chemotherapy-induced peripheral neuropathy. IV. To describe the three-year event-free and overall survival (EFS/OS) in those treated with and without levocarnitine prophylaxis. V. To examine the association of age with asparaginase activity and asparaginase-associated hepatotoxicity during induction. VI. To examine the association of body-mass-index (BMI) percentile (or absolute BMI for young adults) with asparaginase activity and asparaginase-associated hepatotoxicity during induction. VII. To describe adherence by self-report and pill-count to oral levocarnitine in patients randomized to the intervention arm. VIII. To examine the association of plasma levels of carnitine and related markers with the efficacy of levocarnitine supplementation. IX. To determine the impact of inherited genetic variation on hepatoxicity and levocarnitine efficacy. OUTLINE: Patients are randomized to 1 of 2 arms (arm A vs. B). ARM A: Patients receive levocarnitine orally (PO) or intravenously (IV) as a bolus over 2 to 3 minutes or by infusion (over 10 to 30 minutes or per institutional standard) starting prior to standard of care induction chemotherapy with pegaspargase or calaspargase pegol and continued through the earlier of the last day of Induction phase (i.e., day prior to start of next phase) or Induction day 35. Patients may also undergo blood sample collection during screening and on study. ARM B: Patients receive standard of care induction chemotherapy with pegaspargase or calaspargase pegol on study. Patients may also undergo blood sample collection during screening and on study. ARM C (RESCUE): Patients in Arms A and B who develop conjugated hyperbilirubinemia > 3 mg/dL during induction may receive levocarnitine rescue PO or IV as a bolus dose over 2 to 3 minutes or by infusion (over 10 to 30 minutes or per institutional standard) until resolution of conjugated hyperbilirubinemia =< 3 mg/dL (or start of consolidation or the next treatment phase, whichever occurs first).