Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia
About this trial
This is an interventional treatment trial for Childhood Acute Lymphoblastic Leukemia in Remission
Eligibility Criteria
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:
- 0.4 mg/dL (1 month to < 6 months of age)
- 0.5 mg/dL (6 months to < 1 year of age)
- 0.6 mg/dL (1 to 2 years of age)
- 0.8 mg/dL (2 to < 6 years of age)
- 1.0 mg/dL (6 to < 10 years of age)
- 1.2 mg/dL (10 to < 13 years of age)
- 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
- 1.7 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
Sites / Locations
- Children's Oncology Group
- University of California San Francisco Medical Center-Parnassus
- Children's Hospital Colorado
- Childrens Memorial Hospital
- Indiana University Medical Center
- Riley Hospital for Children
- Kosair Children's Hospital
- Johns Hopkins University
- C S Mott Children's Hospital
- The Childrens Mercy Hospital
- Washington University School of Medicine
- University of Nebraska Medical Center
- Hackensack University Medical Center
- Roswell Park Cancer Institute
- New York Medical College
- University of North Carolina
- Nationwide Children's Hospital
- Children's Hospital of Philadelphia
- Vanderbilt-Ingram Cancer Center
- University of Texas Southwestern Medical Center
- Primary Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I
Arm II
Patients undergo filgrastim (G-CSF)-stimulated allogeneic bone marrow transplantation on day 0.
Patients undergo conventional allogeneic bone marrow transplantation on day 0.