Clinical trial · Interventional
Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor
A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies in Remission From HLA Partially-Matched Related Donors
- 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)
The primary hypothesis of this research study is that patients in remission undergoing myeloablative haploidentical hematopoietic stem cell transplantation (HSCT) on the Thomas Jefferson University (TJU) 2 Step treatment regimen will have a disease-free survival (DFS) rate at 1 year that is the same or better than the historical DFS of patients with similar diagnoses and ages undergoing matched sibling HSCT. Based on a review of the literature a DFS rate of 50% or better at 1 year would meet the criterion for an effective alternative therapy. A DFS rate of 75% or better would imply superior efficacy of the TJU 2 Step approach over T-replete matched sibling HSCT.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Aplastic Anemia | — | UNRESOLVED | — |
| Biphenotypic Leukemia | — | UNRESOLVED | — |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphoma | Lymphoma |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Donor Lymphocyte Infusion (DLI) | Biological | — | UNRESOLVED |
| Hematopoietic stem cell transplantation (HSCT) | Device | — | UNRESOLVED |
| Mycophenolate Mofetil (MMF) | Drug | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
| Total Body Irradiation (TBI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TJU 2 Step Regimen
- description
- All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.
- interventionNames
- Radiation: Total Body Irradiation (TBI)
- Biological: Donor Lymphocyte Infusion (DLI)
- Drug: Cyclophosphamide
- Drug: Mycophenolate Mofetil (MMF)
- Drug: Tacrolimus
- Device: Hematopoietic stem cell transplantation (HSCT)
Primary outcomes (2)
- measure
- Disease-Free Survival (DFS)
- timeFrame
- 1 year post-transplant
- description
- 1-year post-transplant disease free survival (DFS), defined as success if a patient is alive and disease free at 1-year post-transplant.
- measure
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. * Diagnoses include: Acute Myeloid Leukemia Myelodysplastic Syndromes Biphenotypic Leukemia Acute Lymphocytic Leukemia Chronic Myeloid Leukemia Chronic Lymphocytic Leukemia Plasma Cell Neoplasms Lymphoma Hodgkin Disease Aplastic Anemia 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 adequate organ function: * LVEF of \> or = 50% * DLCO \> or = 50% of predicted corrected for hemoglobin * Adequate liver function as defined by a serum bilirubin \< or = 1.8, AST or ALT \< or = 2.5X upper limit of normal * Creatinine clearance of \> or = 60 ml/min 4. Performance status \> or = 70% (TJU Karnofsky) 5. HCT-CI Score \< 5 Points 6. Patients must be willing to use contraception if they have childbearing potential 7. Able to give informed consent Exclusion Criteria: 1. Performance status \< or = 70% (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 \< or = 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 ant-thymocyte globulin and have an ATG level of \> or = 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)
Data not yet available