Clinical trial · Interventional
Donor Stem Cell Transplant After Conditioning Therapy in Treating Patients With Hematologic Cancer, Recurrent or Metastatic Solid Tumor, or Other Disease
NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING
- 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 stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy 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 cyclosporine and methotrexate before and after transplant may stop this from happening. PURPOSE: This clinical trial is studying the side effects and how well donor stem cell transplant works when given after conditioning therapy in treating patients with hematologic cancer, recurrent or metastatic solid tumor, or other disease.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Nonmalignant Neoplasm | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| methylprednisolone | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Engraftment (neutrophil, platelet, and red blood cells)
- measure
- Frequency and kinetics of mixed chimerism as assessed by polymerase chain reaction
- measure
- Frequency and severity of regimen-related toxicities
- measure
- Frequency of acute and chronic graft-versus-host disease
- measure
- Immune reconstitution
Secondary outcomes (3)
- measure
- Tumor response rate
- measure
- Duration of tumor response
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* High-risk acute leukemia, including any of the following:
* Refractory acute leukemia
* Acute leukemia beyond first remission
* Acute leukemia in first remission with poor prognostic features (e.g., chromosomal changes suggesting poor prognosis)
* Chronic myelogenous leukemia in second chronic, accelerated, or blastic phase
* Severe aplastic anemia that is not responsive to immunosuppressive therapy
* Myelodysplastic syndromes, including any of the following:
* Refractory anemia (RA) or RA with ringed sideroblasts with severe cytopenia
* RA with excess blasts (RAEB)
* RAEB in transformation
* Chronic myelomonocytic leukemia
* Refractory or relapsed non-Hodgkin or Hodgkin lymphoma
* Multiple myeloma
* Biopsy proven measurable solid tumor meeting 1 of the following criteria:
* Recurrent disease after primary treatment and deemed incurable to standard treatment
* Metastatic disease for which no known standard therapy that is potentially curative or definitely capable of extending life expectancy exists
* Must have a related HLA-haploidentical mismatched (3/6 or fewer loci) donor available
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Bilirubin \< 2.0 mg/dL
* AST \< 3 times upper limit of normal
* Creatinine \< 2.0 mg/dL
* 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