Clinical trial · Interventional
High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Allogeneic Peripheral Blood Progenitor Cell Transplantation Using Histocompatible Sibling-Matched Donor Cells After High-Dose Busulfan/Cyclophosphamide as Therapy for Hematologic Malignancies
NCT00003116CI-TRIAL-00003534completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well giving busulfan, cyclophosphamide, and filgrastim together with peripheral stem cell transplantation from a sibling donor works in treating patients with hematologic cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Hematopoietic reconstitution measured daily during transplant
- timeFrame
- at months 2, 4, 7, and 10, and then every 6 months until disease progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 55 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically diagnosed: * Acute myeloid leukemia in first, second, or third complete remission or first or second early relapse * Acute lymphoblastic leukemia in first, second, or third complete remission or first or second early relapse * Hodgkin's lymphoma in second or third remission or first, second, or third relapse, or refractory * Non-Hodgkin's lymphoma in second or third remission or first, second, or third relapse, or refractory * Multiple myeloma and plasma cell leukemia in second or third remission or first, second, or third relapse, or refractory * Myelodysplastic syndrome deemed suitable for allogeneic bone marrow transplantation * No symptoms or signs of CNS involvement and CNS is disease free on lumbar puncture and brain CT scan * No active meningeal cancer PATIENT CHARACTERISTICS: Age: * 4 to 55 (4 to 60 if donor is identical twin) Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * SGOT/SGPT less than 3 times normal * Bilirubin less than 2.0 mg/dL Renal: * Creatinine less than 2.1 mg/dL * Creatinine clearance at least 60 mL/min (no greater than 1.5 times normal for children under 40 kg) Cardiovascular: * No uncontrolled hypertension * No uncontrolled congestive heart failure * No active angina pectoris requiring nitrates * At least 6 months since prior myocardial infarction * No major ventricular arrhythmia * Left ventricular ejection fraction at least 45% on MUGA Pulmonary: * No severe or symptomatic restrictive or obstructive lung disease * FEV\_1 greater than 50% of predicted * DLCO greater than 50% of predicted Neurologic: * No severe central or peripheral neurologic abnormality Other: * Must have HLA-A,B,C,D/DR identical sibling age 4 to 65, in good health * No insulin-dependent diabetes mellitus * No major thyroid or major adrenal dysfunction * No active infection * No other active malignancy * Not pregnant * HIV negative * HTLV-I and HTLV-II negative PRIOR CONCURRENT THERAPY: Biologic therapy: * No excessive anthracycline exposure, unless endomyocardial biopsy shows less than grade 2 drug effect and cardiac scan shows at least 50% ejection fraction * At least 1 year since prior autologous bone marrow or peripheral blood progenitor cell transplant or allogeneic bone marrow transplant Chemotherapy: * At least 3 weeks since prior chemotherapy * No prior excessive carmustine and bleomycin Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy Surgery: * Not specified Other: * No concurrent nitroglycerin for angina pectoris * No concurrent anti-arrhythmic drugs for major ventricular dysrhythmias
References
Publications (0)
Data not yet available
No reference posted for this study.