Clinical trial · Interventional
Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies With Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device
BT13BTθ51 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 with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related/Haploidentical mobilized peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one year leukemia free survival.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CliniMACs | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Experimental Arm
- description
- Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device
- interventionNames
- Device: CliniMACs
Primary outcomes (1)
- measure
- Evaluate the engraftment of patients receiving unrelated donor or partially matched related donor peripheral stem cells that have T cell depleted and CD19+ B cell depleted using the CliniMACS device.
- timeFrame
- DAY 42
- description
- Engraftment will be defined using the standard CIBMTR definition of ANC \>500 for the first of 3 consecutive days.
Secondary outcomes (3)
- measure
- Assess the probability of one year leukemia free survival (LFS).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 23 Years
Show eligibility criteria text
Inclusion Criteria: Patient: 1. Age. Patient age \< 23 years. Both genders and all races eligible. 2. Disease eligibility 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 Exclusion Criteria: * Patient 1. Patients who do not meet disease, organ or infectious criteria. 2. No suitable donor
References
Publications (0)
Data not yet available