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Status:

COMPLETED

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

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Childhood Acute Lymphoblastic Leukemia in Remission

Childhood Acute Myeloid Leukemia in Remission

Eligibility:

All Genders

Up to 21 years

Phase:

PHASE3

Brief Summary

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. Givin...

Detailed Description

PRIMARY OBJECTIVE: I. Compare improvement in event-free survival of patients with hematologic cancer or other diseases undergoing filgrastim (G-CSF)-stimulated bone marrow transplantation (BMT) vs co...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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:
  • 4 mg/dL (1 month to \< 6 months of age)
  • 5 mg/dL (6 months to \< 1 year of age)
  • 6 mg/dL (1 to 2 years of age)
  • 8 mg/dL (2 to \< 6 years of age)
  • 0 mg/dL (6 to \< 10 years of age)
  • 2 mg/dL (10 to \< 13 years of age)
  • 5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age)
  • 7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
  • Shortening fraction ≥ 27% by echocardiogram OR LVEF ≥ 50% by radionuclide angiogram
  • FEV\_1, FVC, and DLCO ≥ 60% OR meets the following criteria (for patients unable to cooperate for pulmonary function tests):
  • No evidence of dyspnea at rest
  • No exercise intolerance
  • No requirement for supplemental oxygen therapy
  • Not pregnant or nursing
  • No known HIV
  • No known uncontrolled fungal, bacterial, or viral infections
  • Patients acquiring fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT scan
  • No prior allogeneic or autologous stem cell transplantation

Exclusion

    Key Trial Info

    Start Date :

    December 31 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 31 2022

    Estimated Enrollment :

    27 Patients enrolled

    Trial Details

    Trial ID

    NCT00450450

    Start Date

    December 31 2007

    End Date

    March 31 2022

    Last Update

    April 28 2022

    Active Locations (21)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (21 locations)

    1

    Children's Oncology Group

    Arcadia, California, United States, 91006-3776

    2

    University of California San Francisco Medical Center-Parnassus

    San Francisco, California, United States, 94143

    3

    Children's Hospital Colorado

    Aurora, Colorado, United States, 80045

    4

    Childrens Memorial Hospital

    Chicago, Illinois, United States, 60614