Clinical trial · Interventional
Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies
UNRELATED AND PARTIALLY MATCHED RELATED DONOR PERIPHERAL STEM CELL TRANSPLANTATION WITH Alpha/Beta T CELL AND B CELL DEPLETION FOR PATIENTS WITH HEMATOLOGIC 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)
This is a single arm pilot study for patients using α/β T cell-depleted peripheral Stem Cell Transplantation (PSCT) in with alternative donor sources with hematologic malignancies receiving alternative donor (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and graft versus host disease (GVHD), and one year leukemia free survival.
Conditions
Conditions (3)
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 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplasia | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha Beta T cell depletion | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Alpha Beta Total Body Irradiation - total body irradiation (TBI) first
- description
- Alpha Beta Total Body Irradiation - TBI first Day Treatment * 11 Anti-thymocyte globulin (ATG) * 10 ATG * 9 ATG * 8 TBI * 7 TBI * 6 TBI * 5 Thiotepa * 4 Thiotepa * 3 Cyclophosphamide * 2 Cyclophosphamide * 1 Rest 0 Transplant with alpha beta T cell depleted stem cells
- type
- EXPERIMENTAL
- label
- Alpha Beta Total Body Irradiation - TBI last
- description
- Alpha Beta Total Body Irradiation - TBI last Day Treatment * 9 ATG * 8 ATG * 7 Thiotepa + ATG * 6 Thiotepa * 5 Cyclophosphamide * 4 Cyclophosphamide * 3 TBI * 2 TBI * 1 TBI 0 Transplant with alpha beta T cell depleted stem cells
- type
- EXPERIMENTAL
- label
- Alpha Beta Non-irradiation regimen
- description
- Alpha Beta Non-irradiation regimen Day Treatment * 9 Busulfan + ATG * 8 Busulfan + ATG * 7 Busulfan +ATG * 6 Busulfan * 5 Thiotepa * 4 Thiotepa * 3 Cyclophosphamide * 2 Cyclophosphamide * 1 0 Transplant with alpha beta T cell depleted stem cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 23 Years
Show eligibility criteria text
Inclusion Criteria: 1. Leukemias/lymphomas * Acute myeloid leukemia, primary or secondary Disease status: remission or \<10% bone marrow blasts * Myelodysplasia * Acute lymphoblastic leukemia Disease status: in hematologic remission * Chronic myelogenous leukemia Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase. * Mixed lineage or biphenotypic acute leukemia * Lymphoblastic lymphoma Disease status: remission * Burkitt's lymphoma/leukemia: Disease status- in remission 2. Acceptable organ status clearance 3. No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic 4. Signed informed consent. 5. Negative pregnancy test for females of childbearing potential. Exclusion Criteria: 1. Patients who do not meet disease, organ or infectious criteria. 2. No suitable donor 3. Received previous allogeneic transplant Donor must be either unrelated, mismatched up to one antigen/one antigen and one allele or a related, HLA match other than a sibling.
References
Publications (1)
- DERIVEDLeahy AB, Li Y, Talano JA, Elgarten CW, Seif AE, Wang Y, Johnson B, Monos DS, Kadauke S, Olson TS, Freedman J, Wray L, Grupp SA, Bunin N. Unrelated donor alpha/beta T cell- and B cell-depleted HSCT for the treatment of pediatric acute leukemia. Blood Adv. 2022 Feb 22;6(4):1175-1185. doi: 10.1182/bloodadvances.2021005492. PMID 34872106