Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases

Completed · Phase 3

Conditions studied: Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes, Juvenile Myelomonocytic Leukemia, Previously Treated Myelodysplastic Syndromes, Recurrent Childhood Acute Lymphoblastic Leukemia, Secondary Myelodysplastic Syndromes

In brief

This randomized phase III trial is studying donor bone marrow transplant with or without G-CSF to compare how well they work in treating young patients with hematologic cancer or other diseases. Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate and tacrolimus or cyclosporine before and after transplant may stop this from happening. It is not yet known whether donor bone marrow transplant is more effective with or without G-CSF in treating hematologic cancer or other diseases.

Key facts

Study ID

NCT00450450

Run by

Children's Oncology Group

People needed

27

Starts

2007-12-31

Expected to finish

2022-03-31

Last updated by the study team

2022-04-28

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of hematologic cancer or other disease, including any of the following:
• Chronic myelogenous leukemia in first or second chronic phase
• Acute lymphoblastic leukemia (ALL), meeting any of the following criteria:
• Relapsed ALL enrolled on a Children's Oncology Group (COG) relapse clinical trial OR received ≥ 1 round of reinduction therapy (4-6 weeks) and 1 round of intensive consolidation chemotherapy (3-6 weeks)
• ALL in second complete remission (CR)* after a bone marrow, extramedullary, or combined bone marrow and extramedullary relapse
• Very high-risk ALL in first CR, defined as any of the following:
• Philadelphia chromosome-positive ALL
• Hypodiploidy (< 44 chromosomes)
• Mixed lineage leukemia rearrangement
• Induction failure
• Acute myeloid leukemia in first or second CR
• Induction therapy must be completed
• Juvenile myelomonocytic leukemia
• Myelodysplastic syndromes
• No clinically evident CNS or extramedullary disease
• No blasts seen on cerebrospinal fluid cytospin
• Post-relapse reinduction therapy must be completed
• Not planning to receive reduced-intensity conditioning regimen
• Not planning to receive a graft that has undergone T-cell depletion
• No Down syndrome
• Matched sibling donor must be available and must be enrolled on ASCT0631D companion study
• Karnofsky performance status (PS) 60-100% (patients > 16 years of age) OR Lansky PS 60-100% (patients ≤ 16 years of age)
• AST or ALT < 5 times upper limit of normal for age
• Bilirubin < 2.5 mg/dL (unless due to Gilbert's syndrome)
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine base on age and/or gender as follows:

Where it is running

• Children's Oncology Group — Arcadia, California, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Childrens Memorial Hospital — Chicago, Illinois, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• C S Mott Children's Hospital — Ann Arbor, Michigan, United States
• The Childrens Mercy Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• New York Medical College — Valhalla, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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