Clinical trial · Interventional
Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder
A Phase I/II Study of Immunologically Engineered rhG-CSF Mobilized Peripheral Blood Stem Cells (PBSC) for Allogeneic Transplant From HLA Identical, Related Donors for Treatment of 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 chemotherapy drugs before a donor peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and 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. Giving colony-stimulating factors, such as G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored. PURPOSE: This phase I/II trial is studying how well donor peripheral stem cell transplant works in treating patients with myelodysplastic syndrome, acute myeloid leukemia, or myeloproliferative disorder.
Conditions
Conditions (4)
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 |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| in vitro-treated peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of grade II, III, and IV graft-versus-host disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Myelodysplastic syndromes (MDS) that has advanced beyond refractory anemia (RA) * RA with excess blasts (RAEB) (greater than 5% blasts) * RAEB in transformation (greater than 20% but less than 30% blasts) * Acute myeloid leukemia (greater than 30% blasts) that evolved from MDS * Myeloproliferative disorder, including chronic myelomonocytic leukemia, agnogenic myeloid metaplasia, polycythemia vera, or essential thrombosis * No chronic myelogenous leukemia with or without excess (greater than 5%) blasts * Must have an HLA-identical, related donor PATIENT CHARACTERISTICS: Age * 18 to 65 Performance status * Not specified Life expectancy * At least 6 months Hematopoietic * Not specified Hepatic * Bilirubin less than 2 times upper limit of normal (ULN)\* * SGOT/SGPT less than 2 times ULN\* NOTE: \* Unless due to malignancy Renal * Creatinine no greater than 2.0 mg/dL OR * Glomerular filtration rate at least 60 mL/min Cardiovascular * Cardiac ejection fraction at least 45% Pulmonary * DLCO at least 60% of predicted Other * HIV negative * Human antimouse antibody negative * Not pregnant or nursing * Fertile patients must use effective contraception * No other medical condition that would preclude study participation * No hypersensitivity to cyclosporine PRIOR CONCURRENT THERAPY: Biologic therapy * No prior marrow transplantation * No concurrent growth factors for 21 days after study transplantation Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
References
Publications (0)
Data not yet available