Clinical trial · Interventional
Donor Stem Cell Transplant After Busulfan, Fludarabine, and Antithymocyte Globulin in Treating Patients With Hematologic Cancer or Myelodysplastic Syndrome
HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING OF BUSULFAN, FLUDARABINE, AND ANTI-THYMOCYTE GLOBULIN FOR ADULT PATIENTS WITH HEMATOLOGIC MALIGNANCIES AND MYELODYSPLASTIC SYNDROME - A PHASE 2 STUDY
- 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 and antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. It may also stop 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 and abnormal cells (graft-versus-tumor effect). PURPOSE: This phase II trial is studying how well a donor stem cell transplant works after busulfan, fludarabine, and antithymocyte globulin in treating patients with hematologic cancer or myelodysplastic syndrome.
Conditions
Conditions (2)
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 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nonmyeloablative allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- tumor response
- timeFrame
- about 4-8 weeks after transplantation
- description
- leukemia CR, CR duration
Secondary outcomes (2)
- measure
- Donor cell engraftment (neutrophil, platelet, and red blood cells)
- timeFrame
- 10-35 days after transplantation
- description
- neutrophi count over 500/ul
- measure
- Acute and chronic graft-versus-host disease
- timeFrame
- 15-100 days; 100 days to 4 years
- description
- ocurrence of acute or chronic GVHD
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following hematological malignancies:
* Acute leukemia, including any of the following:
* Refractory acute leukemia
* Acute leukemia beyond first remission
* Acute leukemia in first remission with intermediate to poor prognostic features as suggested by chromosomal findings
* Chronic myelogenous leukemia (CML)
* Second chronic phase
* Accelerated phase
* Blastic phase
* Myelodysplastic syndrome (MDS)
* High-risk MDS (refractory anemia with excess blasts \[RAEB\], RAEB in transformation, and chronic myelomonocytic leukemia) can be transplanted without prior therapy or after prior therapy failure with hypomethylating agents
* Low-risk MDS can be considered for transplantation after prior therapy failure with immunosuppressive or hypomethylating agents
* No willing, suitable HLA-matched donor in family or in donor registries
* Patients with active hematologic malignancy, who are felt to be in urgent need of allogeneic hematopoietic cell transplantation, can enroll without a search for HLA-matched unrelated donors
* Related donor with HLA-haploidentical mismatch at 3 or less of 6 loci available
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Bilirubin \< 2.0 mg/dL
* Creatinine \< 2.0 mg/dL
* AST \< 3 times upper limit of normal
* Ejection fraction \> 40% by MUGA
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (1)
- RESULTLee KH, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Hwang HJ, Jung AR, Kim SH, Yun SC, Shin HJ. Reduced-intensity conditioning therapy with busulfan, fludarabine, and antithymocyte globulin for HLA-haploidentical hematopoietic cell transplantation in acute leukemia and myelodysplastic syndrome. Blood. 2011 Sep 1;118(9):2609-17. doi: 10.1182/blood-2011-02-339838. Epub 2011 Jun 28. PMID 21715313