Clinical trial · Interventional
Cyclophosphamide Plus T-Cell Transplantation for Patients With Hematologic Malignancies
Cyclophosphamide Plus Transplantation of Partially HLA-mismatched (Haploidentical), CD8+ T Cell-depleted Peripheral Blood Cells for Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, Lymphoma, or Myeloproliferative Disorders
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of abnormal blood cells, either by killing the cells or by stopping them from dividing. Giving cyclophosphamide together with donor lymphocytes that have been treated in the laboratory may be an effective treatment for myelodysplastic syndromes or myeloproliferative disorders. PURPOSE: This clinical trial is studying the best dose of donor lymphocytes when given together with cyclophosphamide in treating patients with myelodysplastic syndromes or myeloproliferative disorders.
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 |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Donor T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyclophosphamide + T cells
- description
- Conditioning regimen with cyclophosphamide followed by donor T cells on Day 0.
- interventionNames
- Drug: Cyclophosphamide
- Biological: Donor T cells
Primary outcomes (1)
- measure
- Maximum tolerated dose of haploidentical donor lymphocytes
- timeFrame
- 60 days
- description
- Maximum dose in cells per kilogram that did not cause dose-limiting toxicity (defined as grade 3-5 non-hematologic toxicity, death within 60 days related to protocol treatment, aplasia related to treatment, or grade 3-4 graft-vs-host-disease).
Secondary outcomes (2)
- measure
- Disease response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Myelodysplastic syndromes (MDS)
* International Prognostic Scoring System (IPSS) score ≥ intermediate-2
* Chronic myelomonocytic leukemia
* Acute myeloid leukemia arising from MDS
* Must have failed or are ineligible for or intolerant to treatment with azacitidine
* Patients with normal marrow cytogenetics or an isolated 5q- abnormality must have failed or are ineligible for or intolerant to treatment with lenalidomide
* Patients who are HLA-DR15-positive must have failed or are ineligible for pharmacologic immunosuppression (e.g., anti-thymocyte globulin, cyclosporine, steroids)
* No presence of cytotoxic antibodies against donor lymphocytes
* No HLA-identical donor available OR ineligible for HLA-identical allogeneic bone marrow transplantation
* HLA partially mismatched (haploidentical) related donor available
* First-degree related donor, including half-siblings or first cousins
* Inherited recombinant haplotype from parents allowed if donor shares ≥ 1 HLA antigen at each of the HLA-A, -B, and DR loci
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
* Bilirubin \< 3.0 mg/dL
* AST and ALT ≤ 4 times upper limit of normal
* Creatinine \< 3.0 mg/dL
* LVEF \> 35%
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior therapy
* No prior transfusions from donor
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy
* No other concurrent investigational drugsReferences
Publications (0)
Data not yet available