Clinical trial · Interventional
A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative
A Two Step Approach To Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies 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 purpose of this study is to develop a way of treating patients who do not have a completely matched family donor or a readily available unrelated donor with bone marrow transplant by using a partially-matched family donor. Patients receiving this type of transplant will receive chemotherapy and/or radiation to treat their disease. They will also receive their donor's cells in 2 parts. During the first part, the donor's lymphocytes will be exposed to one of the chemotherapy agents to help the patient become tolerant to the lymphocytes. In the second part of the transplant, the patient will receive their donor's stem cells to help recover their peripheral blood counts and establish long-term engraftment. The hypothesis of this study is that in partially-matched allogeneic transplant, there is a defined number of donor T-cells that can be treated and given to the recipient to avoid post-transplant infection without causing severe graft-versus-host disease.
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 |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide (CY) | Drug | Cyclophosphamide | ALIAS |
| Donor Lymphocyte Infusion (DLI) | Biological | — | UNRESOLVED |
| Hematopoietic Stem Cell Transplant (HSCT) | Biological | Hematopoietic Cell Transplantation | ALIAS |
| Mycophenolate Mofetil (MMF) | Drug | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
| Total Body Irradiation (TBI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Haploidentical Allogeneic Transplantation
- description
- Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
- interventionNames
- Radiation: Total Body Irradiation (TBI)
- Biological: Donor Lymphocyte Infusion (DLI)
- Drug: Cyclophosphamide (CY)
- Drug: Tacrolimus
- Drug: Mycophenolate Mofetil (MMF)
- Biological: Hematopoietic Stem Cell Transplant (HSCT)
Primary outcomes (2)
- measure
- Overall Survival of Participants
- timeFrame
- 6 months
- description
- To determine overall survival at 6 months post-transplant.
- measure
- Optimal Dose of CD3+ Donor Lymphocytes (T-cells) for Consistent Engraftment Without GVHD
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 either a one, two or three out of six antigen mismatch at the HLA-A;B;DR loci. 3. Patients without a well-matched unrelated donor or those who have a disease status that precludes a wait for an identified unrelated donor. 4. Patients must adequate organ function: * LVEF of \>45% * FVC or FEV1 \>45% of predicted * Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X upper limit of normal * Serum creatinine \< 2.0 mg/dl or creatinine clearance of \> 40 ml/min 5. Performance status \> 60% (Karnofsky) 6. Patients must be willing to use contraception if they have childbearing potential 7. Able to give informed consent Exclusion Criteria: 1. An eligible HLA-identical sibling donor. 2. Performance status \< 60% (Karnosfsky) 3. HIV positive 4. Active involvement of the central nervous system with malignancy 5. Psychiatric disorder that would preclude patients from signing an informed consent 6. Pregnancy 7. Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder.
References
Publications (1)
- DERIVEDGrosso D, Carabasi M, Filicko-O'Hara J, Kasner M, Wagner JL, Colombe B, Cornett Farley P, O'Hara W, Flomenberg P, Werner-Wasik M, Brunner J, Mookerjee B, Hyslop T, Weiss M, Flomenberg N. A 2-step approach to myeloablative haploidentical stem cell transplantation: a phase 1/2 trial performed with optimized T-cell dosing. Blood. 2011 Oct 27;118(17):4732-9. doi: 10.1182/blood-2011-07-365338. Epub 2011 Aug 25. PMID 21868572