Clinical trial · Interventional
Fludarabine, Busulfan, and Antilymphocyte Globulin Followed by Donor Stem Cell Transplant in Treating Older Patients With Hematological Cancer
Phase II Study of Allogeneic Transplant of Hematopoietic Stem Cells From a Compatible Family Donor in the Treatment of Patients Over 55 Years With Hematological Malignancies
- 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: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antilymphocyte globulin before transplant may stop this from happening. PURPOSE: This phase II trial is studying how well fludarabine, busulfan, and antilymphocyte globulin together with donor stem cell transplant works in treating older patients with hematological cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| therapeutic immune globulin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Allogeneic hematopoietic stem cell transplant-related mortality
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 56 Years
- Maximum age
- 74 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of a hematological malignancy * Candidate for an allogeneic hematopoietic stem cell transplantation * Available HLA-identical related donor PATIENT CHARACTERISTICS: * WHO performance status (PS) 0-1 OR Karnofsky PS 70-100% * Life expectancy \> 6 months * LVEF ≥ 40% * DLCO ≥ 50% * Creatinine clearance ≥ 30 mL/min * Transaminases and/or bilirubin ≤ 2 times upper limit of normal (ULN) * No other cancer within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix * No human T-cell leukemia virus type 1 positivity * No HIV positivity * No uncontrolled bacterial, viral, or fungal infection * No contraindications to the study drugs * No concurrent serious and uncontrolled disease PRIOR CONCURRENT THERAPY: * At least 1 month since prior participation in a clinical trial
References
Publications (0)
Data not yet available