Clinical trial · Interventional
Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
A Phase III Randomized Trial of G-CSF Stimulated Bone Marrow vs. Conventional Bone Marrow as a Stem Cell Source In Matched Sibling Donor Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Acute Lymphoblastic Leukemia in Remission | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Childhood Acute Myeloid Leukemia in Remission | Childhood Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Childhood Chronic Myelogenous Leukemia | Childhood Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Childhood Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.85 |
| Chronic Phase Chronic Myelogenous Leukemia | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| de Novo Myelodysplastic Syndromes | — | UNRESOLVED | — |
| Juvenile Myelomonocytic Leukemia |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo filgrastim (G-CSF)-stimulated allogeneic bone marrow transplantation on day 0.
- interventionNames
- Procedure: allogeneic bone marrow transplantation
- Other: laboratory biomarker analysis
- Biological: filgrastim
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients undergo conventional allogeneic bone marrow transplantation on day 0.
- interventionNames
- Procedure: allogeneic bone marrow transplantation
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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 transplantationReferences
Publications (0)
Data not yet available