Clinical trial · Interventional
Reduced Intensity Haploidentical Transplant for Hematological Malignancies
A Two Step Approach To Non-Myeloablative Matched-Sibling Allogeneic Hematopoietic Stem Cell Transplantation for Hematological 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)
Many patients with hematological malignancies (leukemia, lymphoma, multiple myeloma) cannot undergo hematopoietic stem cell transplantation (HSCT) because they do not have a well matched donor. HSCT from partially matched family donors (haploidentical HSCT) is an option for most patients but has been associated with poor outcomes. This study was designed to test whether using an exact amount of a donor's lymphocytes (white cells) and dividing the transplant process into 2 steps, would increase overall survival by decreasing complications. The therapy is reduced intensity so it is targeted, but not limited to, patients over the age of 65 or those who have had previous transplants.
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 |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Haploidentical Allogeneic Transplantation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transplantation
- interventionNames
- Device: Haploidentical Allogeneic Transplantation
Primary outcomes (1)
- measure
- Overall Survival at 6 Months Post-transplant in Patients Receiving a Partially-matched Related Donor Allogeneic Transplant After Reduced-intensity Conditioning
- timeFrame
- 6 months
- description
- Number of patients alive at 6 months post-transplant
Secondary outcomes (2)
- measure
- Number of Participants With Successful Engraftment
- timeFrame
- 6 months
- 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 in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. 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 who have sibling donors with a one antigen mismatch due to recombination will not be enrolled in this protocol. 4. Patients must adequate organ function: 1. LVEF of \>45% 2. DLCO \>45% of predicted corrected for hemoglobin 3. Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X upper limit of normal 4. Serum creatinine \< 2.0 mg/dl or creatinine clearance of \> 40 ml/min 5. Performance status \> 70% (Karnofsky) 6. Patients must be willing to use contraception if they have childbearing potential 7. Able to give informed consent Exclusion Criteria: 1. Performance status of \< 70% (Karnofsky) 2. HIV positive 3. Active involvement of the central nervous system with malignancy 4. Psychiatric disorder that would preclude patients from signing an informed consent 5. Pregnancy 6. Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder or complications there from. 7. Patients who have received alemtuzumab within 8 weeks of transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin and have ATG levels of \> 2 µgm/ml. 8. Patients who cannot receive cyclophosphamide 9. 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