Clinical trial · Interventional
Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer
Matched Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplantation With a Conditioning Regimen of Targeted Busulfan, Cyclophosphamide, and Thymoglobulin
- 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 chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft Versus Host Disease | — | UNRESOLVED | — |
| 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 |
| Secondary Myelofibrosis | — | UNRESOLVED | — |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| flow cytometry | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Unrelated Donor Allogeneic
- description
- Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
- interventionNames
- Biological: anti-thymocyte globulin
- Drug: busulfan
- Drug: cyclophosphamide
- Drug: mycophenolate mofetil
- Drug: tacrolimus
- Genetic: polymerase chain reaction
- Genetic: polymorphism analysis
- Other: flow cytometry
- Other: laboratory biomarker analysis
- Other: pharmacogenomic studies
- Other: pharmacological study
- Procedure: allogeneic bone marrow transplantation
- Procedure: allogeneic hematopoietic stem cell transplantation
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- Transplantation-related Mortality at 100 Days Post-transplantation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed diagnosis of 1 of the following: * Acute myeloid leukemia * Acute lymphocytic leukemia * Chronic myelogenous leukemia beyond first chronic phase (i.e., 2nd chronic phase, accelerated phase, or blast crisis) * Multiple myeloma * Myelodysplastic syndromes * Malignant lymphoma * Myelofibrosis * Requirement for myeloablative conditioning regimen confirmed by attending physician * Available donor must meet the following criteria: * HLA phenotypically identical unrelated donor by low, intermediate, or high resolution for HLA class I antigens, and by high resolution for HLA class II antigens * Matched at the A, B, and DRβ1 loci * Single HLA-A or HLA-B antigen mismatch allowed * Meets all National Marrow Donor Program or foreign registry criteria for allogeneic bone marrow/stem cell donors * Peripheral blood stem cells are the preferred product on this study but bone marrow is allowed * Karnofsky performance status 70-100% * DLCO ≥ 50% predicted * LVEF ≥ 45% * Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 65 mL/min * Serum total bilirubin ≤ 2.0 mg/dL * Fertile patients must use effective contraception Exclusion Criteria: * No active uncontrolled infection * Not pregnant or nursing/negative pregnancy test * No HIV infection * No chronic active hepatitis B or C or evidence of cirrhosis on liver biopsy
References
Publications (0)
Data not yet available