Clinical trial · Interventional
Fludarabine and Busulfan Followed by Donor Peripheral Stem Cell Transplant and Antithymocyte Globulin, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Cancer
Conditioning For Hematopoietic Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid 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, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of abnormal and 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 system and help destroy any remaining abnormal or cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin, tacrolimus, and methotrexate before or after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan followed by donor peripheral stem cell transplant and antithymocyte globulin, tacrolimus, and methotrexate works in treating patients with myeloid 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 |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Incidence and severity of acute graft-versus-host disease (GVHD)
- measure
- Incidence of donor engraftment
Secondary outcomes (9)
- measure
- Pharmacokinetics of IV busulfan including interdose variability and evaluation of a limited sampling strategy
- measure
- Pharmacokinetics of antithymocyte globulin
- measure
- Pharmacokinetics of fludarabine phosphate and its effect on lymphocytes
- measure
- Incidence of specific toxic effects ≥ grade 3
- measure
- Incidence and severity of chronic GVHD
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following myeloid malignancies:
* Chronic myelogenous leukemia meeting 1 of the following criteria:
* Chronic phase
* Accelerated phase
* Treated blast phase
* Acute myeloid leukemia meeting 1 of the following criteria:
* In remission
* In early relapse, defined as \< 10% marrow blasts
* Myelodysplastic syndromes, including all risk groups
* Other myeloproliferative disorders
* HLA-A, -B, -C, -DRB1, and -DQB1 matched related or unrelated donor available
PATIENT CHARACTERISTICS:
* No other disease that would severely limit life expectancy
* AST ≤ 2 times normal
* Creatinine ≤ 2 times normal OR creatinine clearance ≥ 60 mL/min
* No cardiac insufficiency requiring treatment
* No symptomatic coronary artery disease
* PO\_2 ≥ 70 mm Hg AND DLCO ≥ 70% of predicted OR PO \_2 ≥ 80 mm Hg AND DLCO ≥ 60% of predicted
* HIV negative
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* No post-transplantation growth factor during methotrexate administrationReferences
Publications (0)
Data not yet available