Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03524235 | Haploidentical Stem Cell Transplant with Prophylactic Natural Killer DLI for Lymphoma, Multiple Myeloma, and CLL | PHASE1 | COMPLETED | 20 | — | — | Jul 18, 2018 | Nov 6, 2024 | Nov 12, 2024 | 1 | United States |
Proportion of patients undergoing BFR-TBI conditioning + haploidentical alloHSCT alive at 30 days post-transplantation.
| Arm | Type | Description |
|---|---|---|
| Subjects | EXPERIMENTAL | Pre-Transplantation Conditioning (Bendamustine, Fludarabine, and Rituximab + Total Body Irradiation) + Haploidentical Stem Cell Transplantation with CD56-enriched donor lymphocyte infusion |
| Controls | NO_INTERVENTION | Patients undergoing standard-of-care reduced-intensity peripheral blood allogeneic stem cell transplantation (any indication, donor source, conditioning regimen) using PTCy GVHD prophylaxis. |
| Name | Type | Description |
|---|---|---|
| Total Body Irradiation | RADIATION | Pre-Transplantation Total Body Irradiation |
| Haploidentical Stem Cell Transplantation | PROCEDURE | Haploidentical Stem Cell Transplantation |
| CD56-Enriched Donor Lymphocyte Infusion | BIOLOGICAL | CD56-Enriched Donor Lymphocyte Infusion |
| Bendamustine | DRUG | Pre-Transplantation Bendamustine |
| Fludarabine | DRUG | Pre-Transplantation Fludarabine |
| Rituximab | DRUG | Pre-Transplantation Rituximab (Rituximab for lymphoma diagnosis only) |
General Inclusion Criteria (For Treatment Groups) * Patient age 18 - 75 years * ECOG 0 - 2 * HIV-positive patients are allowed if these criteria are met: 1. No history of opportunistic infections 2. CD4+ cell count greater or equal to 250 cells/mm3 3. No history of non-malignancy AIDS-defini...