Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

NCT ID: NCT00381680

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31

Brief Summary

This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways and different doses may kill more cancer cells..

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the efficacy of an intensive chemotherapy regimen (based on POG-9412) for pediatric patients with intermediate-risk relapsed B-precursor acute lymphoblastic leukemia.

SECONDARY OBJECTIVES:

I. To determine levels of minimal residual disease (MRD) present at the end of the first & third blocks of Induction and determine if higher MRD levels at these times identify patients at higher risk of relapse who might be candidates for alternative therapies in future trials.

II. To determine whether common polymorphisms in candidate genes are associated with the frequency of vincristine adverse effects (peripheral neuropathy, syndrome of inappropriate antidiuretic hormone secretion [SIADH], or constipation) and with anti-leukemic response (level of end-Induction MRD).

III. Compare, descriptively, the outcomes of patients treated with combination chemotherapy vs those treated with matched sibling-related donor hematopoietic stem cell transplantation (for those with eligible donors).

IV. To use deoxyribonucleic acid (DNA) arrays to characterize patterns of gene expression that predict treatment failure, and to compare gene expression profiles at the time of relapse with those at initial diagnosis to gain an understanding of the pathways that may be involved in disease resistance.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment regimens (randomization closed as of 09/2010).

INDUCTION THERAPY 1 (WEEKS 1-5):

Regimen A: Patients receive low-dose vincristine intravenously (IV) on days 1, 8, 15, and 22; prednisone orally (PO) 3 times daily (TID) on days 1-28; doxorubicin hydrochloride IV over 15 minutes on day 1; pegaspargase intramuscularly (IM) on days 2, 8, 15, and 22; cytarabine intrathecally (IT) on day 1; and methotrexate IT* on days 15 and 29.

Regimen B: (closed to accrual as of 09/2010)***: Patients receive high-dose vincristine IV on days 1, 8, 15, and 22 and prednisone, doxorubicin hydrochloride, pegaspargase, cytarabine, and methotrexate* as in Regimen A.

NOTE: *Central nervous system (CNS)-positive patients do not receive methotrexate IT. In both arms, CNS-positive patients receive intrathecal triple therapy (ITT) comprising methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1, 8, 15, 22, and 29. CNS-positive patients not achieving remission after induction therapy 1 receive one additional dose of ITT on day 36. Patients in both arms then proceed to induction therapy 2**.

NOTE: **Patients who are CNS-positive at relapse receive induction therapy 3 BEFORE induction therapy 2.

NOTE: ***Patients already enrolled on Regimen B are crossover to Regimen A.

INDUCTION THERAPY 2 (WEEKS 6-10 or 7-11): Once blood counts recover, all patients receive etoposide phosphate IV over = 1 hour and cyclophosphamide IV over 1 hour on days 1-5; high-dose methotrexate IV continuously over 24 hours on day 22; leucovorin calcium IV or PO beginning 42 hours after start of high-dose methotrexate and continuing every 6 hours for at least 3 doses; and methotrexate IT* on days 1 and 22. Patients also receive filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 6 and continuing until blood counts recover.

NOTE: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive ITT on days 1 and 22. Patients with testicular-relapse with persistent testicular disease at the end of induction therapy 1 undergo testicular radiotherapy once daily (QD), 5 days a week, for 12 days during induction therapy 2**.

NOTE: **Radiotherapy should be completed before beginning high-dose methotrexate (week 9) chemotherapy.

All patients then proceed to induction therapy 3.

INDUCTION THERAPY 3 (WEEKS 11-15 or 12-16): All patients receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, and 9, and asparaginase IM on days 2 and 9. Patients also receive G-CSF IV or SC beginning on day 10 and continuing until blood counts recover. Patients with a suitable HLA-matched related donor are removed from study and proceed to stem cell transplantation. Patients without a suitable HLA-matched related donor proceed to intensification therapy 1 (as per their randomized regimen in induction therapy 1).

INTENSIFICATION THERAPY 1 (WEEKS 16-27 or 17-28):

Regimen A: Patients receive low-dose vincristine IV and high-dose methotrexate IV continuously over 24 hours on day 1; leucovorin calcium IV or orally beginning 42 hours after start of high-dose methotrexate and continuing every 6 hours for at least 3 doses; oral mercaptopurine once daily on days 2-6; etoposide phosphate IV over ≥ 1 hour and cyclophosphamide IV over 1 hour on day 8; and methotrexate IT* on day 15. Treatment repeats every 21 days for 4 courses (with the exception of IT methotrexate which repeats for only 3 courses).

Regimen B: Patients receive high-dose vincristine IV on day 1 and high-dose methotrexate, leucovorin calcium, mercaptopurine, etoposide phosphate, cyclophosphamide, and methotrexate IT* as in Regimen A. (closed to accrual as of 09/2010)

NOTE: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive ITT on day 15. ITT repeats every 3 weeks for 3 courses.

NOTE: ** Patients already enrolled on Regimen B are crossover to Regimen A.

Patients in both regimens then proceed to reinduction therapy (as per their randomized regimen in induction therapy 1).

REINDUCTION THERAPY (WEEKS 28-32 or 29-33):

Regimen A: Patients receive low-dose vincristine IV and doxorubicin hydrochloride IV over 15 minutes on days 1, 8, and 15, oral dexamethasone twice daily on days 1-7 and 15-21, pegaspargase IM on days 2 and 15, and methotrexate IT* on days 1 and 28.

Regimen B: Patients receive high-dose vincristine IV on days 1, 8, and 15 and doxorubicin hydrochloride, dexamethasone, pegaspargase, and methotrexate IT* as in Regimen A. (closed to accrual as of 09/2010)

NOTE: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive ITT on days 1 and 28.

NOTE: ** Patients already enrolled on Regimen B are crossover to Regimen A. Patients in both regimens then proceed to intensification therapy 2 (as per their randomized regimen in induction therapy 1).

INTENSIFICATION THERAPY 2 (WEEKS 33-56 or 34-57):

Regimen A: Once blood counts recover, patients receive high-dose cytarabine IV over 3 hours on days 1 and 2; pegaspargase IM on day 2; low-dose vincristine IV on days 22 and 29; high-dose methotrexate IV on day 22; leucovorin calcium IV or orally beginning 42 hours after start of high-dose methotrexate and continuing every 6 hours for at least 3 doses; oral mercaptopurine once daily on days 23-27; etoposide phosphate IV over ≥ 1 hour and cyclophosphamide IV over 1 hour on day 29; and methotrexate IT* on day 36. Patients also receive G-CSF IV or SC beginning on day 3 and continuing until blood counts recover. Treatment repeats every 42 days for 4 courses (with the exception of IT methotrexate which only repeats for 3 courses).

Regimen B: Patients receive high-dose cytarabine, high-dose methotrexate, leucovorin calcium, pegaspargase, mercaptopurine, etoposide phosphate, cyclophosphamide, methotrexate IT*, and G-CSF as in Regimen A. Patients also receive high-dose vincristine IV on days 22 and 29.

NOTE: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive ITT on day 36. Treatment repeats every 6 weeks for 3 courses.

Patients in both regimens then proceed to maintenance therapy (as per their randomized regimen in induction therapy 1).

MAINTENANCE THERAPY (week 57-106 or 58-107):

Regimen A: Patients receive methotrexate IT on day 1* and then PO on days 8, 15, 22, 29, and 36; mercaptopurine PO QD on days 1-42; dexamethasone PO twice daily (BID) on days 1-5; and low-dose vincristine IV and cyclophosphamide IV over 1 hour on days 43, 50, 57, and 64. Treatment repeats every 70 days for 5 courses.

Regimen B: Patients receive methotrexate*, mercaptopurine, dexamethasone, and cyclophosphamide as in Regimen A. Patients also receive high-dose vincristine IV on days 43, 50, 57, and 64.

NOTE: *CNS-positive patients receive methotrexate IT on day 1, instead of oral methotrexate.

Beginning in week 1 of the first maintenance therapy course, patients with CNS relapse undergo cranial radiotherapy QD, 5 days a week, for 10 days. Patients with CNS relapse do not receive any IT therapy during maintenance therapy.

After completion of study therapy, patients are followed periodically for 5 years.

Conditions

B-cell Childhood Acute Lymphoblastic Leukemia; L1 Childhood Acute Lymphoblastic Leukemia; L2 Childhood Acute Lymphoblastic Leukemia; Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regimen A: Standard vincristine dosing

See detailed description.

Group Type: ACTIVE_COMPARATOR

vincristine sulfate

Intervention Type: DRUG

Given IV

prednisone

Intervention Type: DRUG

Given PO

doxorubicin hydrochloride

Intervention Type: DRUG

Given IV

pegaspargase

Intervention Type: DRUG

Given IM

cytarabine

Intervention Type: DRUG

Given IT or IV

methotrexate

Intervention Type: DRUG

Given IT or IV

dexamethasone

Intervention Type: DRUG

Given PO

etoposide

Intervention Type: DRUG

Given IV

cyclophosphamide

Intervention Type: DRUG

Given IV

leucovorin calcium

Intervention Type: DRUG

Given IV or PO

filgrastim

Intervention Type: BIOLOGICAL

Given IV or SC

asparaginase

Intervention Type: DRUG

Given IM

mercaptopurine

Intervention Type: DRUG

Given PO

Arm B: Randomized High Dose Vincristine regimen

See detailed description. Closed to accrual as of 09/2010).

Group Type: EXPERIMENTAL

vincristine sulfate

Intervention Type: DRUG

Given IV

prednisone

Intervention Type: DRUG

Given PO

doxorubicin hydrochloride

Intervention Type: DRUG

Given IV

pegaspargase

Intervention Type: DRUG

Given IM

cytarabine

Intervention Type: DRUG

Given IT or IV

methotrexate

Intervention Type: DRUG

Given IT or IV

dexamethasone

Intervention Type: DRUG

Given PO

etoposide

Intervention Type: DRUG

Given IV

cyclophosphamide

Intervention Type: DRUG

Given IV

leucovorin calcium

Intervention Type: DRUG

Given IV or PO

filgrastim

Intervention Type: BIOLOGICAL

Given IV or SC

asparaginase

Intervention Type: DRUG

Given IM

mercaptopurine

Intervention Type: DRUG

Given PO

Interventions

vincristine sulfate

Given IV

Intervention Type: DRUG

prednisone

Given PO

Intervention Type: DRUG

doxorubicin hydrochloride

Given IV

Intervention Type: DRUG

pegaspargase

Given IM

Intervention Type: DRUG

cytarabine

Given IT or IV

Intervention Type: DRUG

methotrexate

Given IT or IV

Intervention Type: DRUG

dexamethasone

Given PO

Intervention Type: DRUG

etoposide

Given IV

Intervention Type: DRUG

cyclophosphamide

Given IV

Intervention Type: DRUG

leucovorin calcium

Given IV or PO

Intervention Type: DRUG

filgrastim

Given IV or SC

Intervention Type: BIOLOGICAL

asparaginase

Given IM

Intervention Type: DRUG

mercaptopurine

Given PO

Intervention Type: DRUG

Other Intervention Names

leurocristine sulfate; VCR; Vincasar PFS; DeCortin; Deltra; ADM; ADR; Adria; Adriamycin PFS; Adriamycin RDF; L-asparaginase with polyethylene glycol; Oncaspar; PEG-ASP; PEG-L-asparaginase; ARA-C; arabinofuranosylcytosine; arabinosylcytosine; Cytosar-U; cytosine arabinoside; amethopterin; Folex; methylaminopterin; Mexate; MTX; Aeroseb-Dex; Decaderm; Decadron; DM; DXM; EPEG; VP-16; VP-16-213; CPM; CTX; Cytoxan; Endoxan; Endoxana; CF; CFR; LV; G-CSF; Neupogen; ASNase; Colaspase; Crasnitin; Elspar; L-ASP; 6-mercaptopurine; 6-MP; Leukerin; MP

Eligibility Criteria

Inclusion Criteria

• Diagnosis of acute lymphoblastic leukemia (ALL)

• Bone marrow with > 25% L1 or L2 lymphoblasts (M3 marrow)

• Patients with > 25% L3 marrow lymphoblasts and/or evidence of c-myc translocation are not eligible (considered Burkitt's or mature B-cell leukemia)
• Intermediate-risk relapsed disease, meeting 1 of the following criteria:

• Bone marrow relapse ≥ 36 months after initial diagnosis (defined as M3 marrow after previous remission from ALL)
• Combined bone marrow and extramedullary (CNS* and/or testicular**) relapse ≥ 36 months after initial diagnosis
• Isolated extramedullary (CNS* and/or testicular**) relapse < 18 months after initial diagnosis
• The following subtypes are not allowed:

• T-lineage ALL
• Mature B-cell (Burkitt's) leukemia (defined as L3 morphology and/or evidence of c-myc translocation)
• Philadelphia-chromosome positive disease
• No Down syndrome (trisomy 21)
• Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by radionuclide angiogram
• Bilirubin < 3.0 mg/dL
• Not pregnant
• Fertile patients must use effective contraception
• No history of peripheral neuropathy >= grade 3 within the past month
• No toxicity (i.e. peripheral neuropathy) >= grade 3 attributable to vincristine within the past month
• At least 5 days since prior intrathecal chemotherapy
• No prior hematopoietic stem cell or marrow transplantation
• No prior cranial radiotherapy > 1200 cGy (for patients with CNS relapse)
• No concurrent stem cell transplant
• No concurrent alternative therapy
• No concurrent itraconazole in patients receiving vincristine
• No concurrent intensity-modulated radiotherapy

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Children's Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glen Lew, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

Children's Hospital of Alabama

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Phoenix Childrens Hospital

Phoenix, Arizona, United States

University of Arizona Health Sciences Center

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Children's Oncology Group

Arcadia, California, United States

Southern California Permanente Medical Group

Downey, California, United States

City of Hope Medical Center

Duarte, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Miller Children's Hospital

Long Beach, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Children's Hospital Central California

Madera, California, United States

Children's Hospital and Research Center at Oakland

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Childrens Hospital of Orange County

Orange, California, United States

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, United States

Sutter General Hospital

Sacramento, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

University of California San Francisco Medical Center-Parnassus

San Francisco, California, United States

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Lombardi Comprehensive Cancer Center at Georgetown University

Washington D.C., District of Columbia, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Lee Memorial Health System

Fort Myers, Florida, United States

University of Florida

Gainesville, Florida, United States

Nemours Children's Clinic - Jacksonville

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Miami Children's Hospital

Miami, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

Florida Hospital

Orlando, Florida, United States

M D Anderson Cancer Center- Orlando

Orlando, Florida, United States

Nemours Childrens Clinic - Orlando

Orlando, Florida, United States

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States

All Children's Hospital

St. Petersburg, Florida, United States

Saint Joseph Children's Hospital of Tampa

Tampa, Florida, United States

Saint Mary's Hospital

West Palm Beach, Florida, United States

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, United States

Georgia Regents University

Augusta, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

University of Hawaii

Honolulu, Hawaii, United States

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, United States

University of Illinois

Chicago, Illinois, United States

Childrens Memorial Hospital

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Advocate Hope Children's Hospital

Oak Lawn, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Southern Illinois University

Springfield, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Saint Vincent Hospital and Health Services

Indianapolis, Indiana, United States

Raymond Blank Children's Hospital

Des Moines, Iowa, United States

University of Kentucky

Lexington, Kentucky, United States

Kosair Children's Hospital

Louisville, Kentucky, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Children's Hospital-Main Campus

New Orleans, Louisiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Eastern Maine Medical Center

Bangor, Maine, United States

Maine Children's Cancer Program

Scarborough, Maine, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Wayne State University

Detroit, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Kalamazoo Center for Medical Studies

Kalamazoo, Michigan, United States

Michigan State University - Breslin Cancer Center

Lansing, Michigan, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

University of Minnesota Medical Center-Fairview

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University of Missouri-Columbia

Columbia, Missouri, United States

The Childrens Mercy Hospital

Kansas City, Missouri, United States

Saint John's Mercy Medical Center

St Louis, Missouri, United States

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

UMDNJ - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Saint Joseph's Regional Medical Center

Paterson, New Jersey, United States

Overlook Hospital

Summit, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, United States

New York University Langone Medical Center

New York, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

State University of New York Upstate Medical University

Syracuse, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

New York Medical College

Valhalla, New York, United States

Mission Hospitals Inc

Asheville, North Carolina, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Presbyterian Hospital

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

The Children's Medical Center of Dayton

Dayton, Ohio, United States

Mercy Children's Hospital

Toledo, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Legacy Emanuel Children's Hospital

Portland, Oregon, United States

Legacy Emanuel Hospital and Health Center

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Palmetto Health Richland

Columbia, South Carolina, United States

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, United States

Greenville Cancer Treatment Center

Greenville, South Carolina, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

T C Thompson Children's Hospital

Chattanooga, Tennessee, United States

East Tennessee Childrens Hospital

Knoxville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Texas Tech University Health Science Center-Amarillo

Amarillo, Texas, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Covenant Children's Hospital

Lubbock, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States

Scott and White Memorial Hospital

Temple, Texas, United States

Primary Children's Medical Center

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Childrens Hospital-King's Daughters

Norfolk, Virginia, United States

Carilion Clinic Children's Hospital

Roanoke, Virginia, United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, United States

Madigan Army Medical Center

Tacoma, Washington, United States

West Virginia University Charleston

Charleston, West Virginia, United States

Saint Vincent Hospital

Green Bay, Wisconsin, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Marshfield Clinic

Marshfield, Wisconsin, United States

Midwest Children's Cancer Center

Milwaukee, Wisconsin, United States

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

IWK Health Centre

Halifax, Nova Scotia, Canada

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, Canada

Chedoke-McMaster Hospitals

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

Children's Hospital

London, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Hospital Sainte-Justine

Montreal, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Swiss Pediatric Oncology Group - Bern

Bern, , Switzerland

Swiss Pediatric Oncology Group - Lausanne

Lausanne, , Switzerland

Countries

United States; Australia; Canada; Switzerland

References

Lew G, Chen Y, Lu X, Rheingold SR, Whitlock JA, Devidas M, Hastings CA, Winick NJ, Carroll WL, Wood BL, Borowitz MJ, Pulsipher MA, Hunger SP. Outcomes after late bone marrow and very early central nervous system relapse of childhood B-acute lymphoblastic leukemia: a report from the Children's Oncology Group phase III study AALL0433. Haematologica. 2021 Jan 1;106(1):46-55. doi: 10.3324/haematol.2019.237230.

Reference Type: DERIVED

PMID: 32001530 (View on PubMed)

Related Links

https://nctn-data-archive.nci.nih.gov/

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Other Identifiers

NCI-2009-00306

Identifier Type: REGISTRY

Identifier Source: secondary_id

COG-AALL0433

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000495359

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA098543

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AALL0433

Identifier Type: -

Identifier Source: org_study_id