Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
Condition: 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
MeSH terms: Leukemia; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Syndrome
Intervention: allogeneic bone marrow transplantation; laboratory biomarker analysis; filgrastim
Intervention description: Patients undergo allogeneic BMT; Correlative studies; Given IV
Intervention MeSH terms: Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

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. 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.
    

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