Clinical trial · Interventional
Haploidentical Donor Hematopoietic Stem Cell Transplant in Treating Patients With Hematologic Malignancies
A Two Step Approach to Haploidentical Hematopoietic Stem Cell Transplantation for Patients in Remission From HLA Partially-Matched Related Donors-Effect of Maternal Donors on Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial was closed due to poor accrual.
Summary
Brief summary (as posted)
This phase II trial studies how well haploidentical donor hematopoietic stem cell transplant works in treating patients with hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Giving an infusion of the donor's T cells (donor lymphocyte infusion) may replace the patient's immune cells and help destroy any remaining cancer cells. When the stem cells from a related donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic hematopoietic stem cell transplantation (HSCT) | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Donor lymphocytes infusion (DLI) | Biological | — | UNRESOLVED |
| Mycophenolate mofetil | Drug | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
| Total-body irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (haploidentical allogeneic HSCT)
- description
- Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.
- interventionNames
- Radiation: Total-body irradiation
- Biological: Donor lymphocytes infusion (DLI)
- Drug: Cyclophosphamide
- Procedure: Allogeneic hematopoietic stem cell transplantation (HSCT)
- Drug: Tacrolimus
- Drug: Mycophenolate mofetil
Primary outcomes (1)
- measure
- Number of Participants With Disease-free Survival (DFS)
- timeFrame
- 1 year
- description
- Disease free survival (DFS), defined as the time to death, relapse or disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Any patient with a hematologic or oncologic diagnosis without morphological evidence of disease in which allogeneic HSCT is thought to be beneficial. 2. Patients must have a related donor who is a two or more allele mismatch at the HLA-A; B; C; DR loci. 3. Patients must have adequate organ function: 1. LVEF (Left ventricular ejection fraction) of \>50% 2. Diffusion Capacity for Carbon Monoxide (DLCO) \>50% of predicted corrected for hemoglobin 3. Adequate liver function as defined by a serum bilirubin \<1.8, Aspartate Aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5X upper limit of normal 4. Creatinine clearance of \> 60 ml/min 4. Performance status \> 80% (TJU Karnofsky) 5. Hematopoietic Comorbidity Index (HCT-CI) Score \< 5 Points 6. Patients must be willing to use contraception if they have childbearing potential 7. Able to give informed consent, or if decisionally impaired, have a legal next of kin or guardian that can give informed consent Exclusion Criteria: 1. Performance status \< 80 % (TJU Karnofsky) 2. HCT-CI Score \> 5 Points 3. Combination of Performance status of \< 80% (TJU Karnofsky) and an HCT-CI of 4 points or more. 4. HIV positive 5. Active involvement of the central nervous system with malignancy 6. Psychiatric disorder that would preclude patients from signing an informed consent 7. Pregnancy 8. Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder 9. Patients who have received alemtuzumab within 8 weeks of the transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin and have an ATG level of \> 2 ugm/ml 10. Patients who cannot receive cyclophosphamide 11. Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
References
Publications (0)
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