Phase 3
N=27
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 · Childhood Myelodysplastic Syndromes · Chronic Phase Chronic Myelogenous Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00450450 ↗Enrolled (actual)
27
Serious AEs
3.9%
Results posted
May 2017
Primary outcome: Primary: Estimated Two-year Event-free Survival (EFS) — 66; 83 Percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- allogeneic bone marrow transplantation (Procedure); laboratory biomarker analysis (Other); filgrastim (Biological)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Two-year Event-free Survival (EFS) |
66; 83 | — |
| SECONDARY Estimated Graft Failure Rate |
0; 0 | — |
| SECONDARY Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD) |
7.69; 15.38 | — |
| SECONDARY Estimated 100-day Transplant Related Mortality (TRM) Percentage |
0; 7.69 | — |
| SECONDARY Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD) |
7.69; 0 | — |
| SECONDARY Estimated Median Time to Neutrophil Engraftment |
23; 20 | — |
| SECONDARY Estimated Median Length of Initial Hospitalization |
— | — |
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 ( 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
Data sourced from ClinicalTrials.gov (NCT00450450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.