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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01497184 | Infusion of Allogeneic CD19-Specific T Cells From Peripheral Blood | PHASE1 | COMPLETED | 95 | — | — | Dec 1, 2011 | Mar 8, 2021 | Mar 13, 2025 | 1 | United States |
MTD is highest dose level where 2 of 6 treated participants have dose limiting toxicity (DLT). DLT defined as new adverse event attributable to donor lymphocyte infusion (DLI) grade 3 or \> involving cardiopulmonary, gastrointestinal, hepatic (excluding albumin), neurological, or renal common toxicity criteria (CTC) version 4 parameters, lasts \> 3 days and possibly related to DLI within 30 days of infusion.
| Arm | Type | Description |
|---|---|---|
| DLI (Adults) | EXPERIMENTAL | Arm 1: Allogeneic donor lymphocyte infusion (DLI) starting dose not to exceed 10\^6/m\^2 intravenously (IV) between 6 weeks - 12 weeks following date of allogeneic hematopoietic stem-cell transplantation (HSCT) as a planned DLI. |
| DLI any time | EXPERIMENTAL | Arm 2: DLI will be administered at any point after disease recurrence following HSCT. |
| DLI Pediatrics | EXPERIMENTAL | Arm 3: DLI administered intravenously between 6 weeks and 12 weeks following date of HSCT as a planned DLI in pediatric patients, aged 1-17 years-old. |
| DLI - Haplo-Identical Family Donor | EXPERIMENTAL | Arm 4: DLI administered as planned DLI or after recurrence in adult and pediatric patients undergoing transplant with a haplo-identical family donor. |
| Name | Type | Description |
|---|---|---|
| HSCT | PROCEDURE | Hematopoietic stem-cell transplant using cells from a matched family donor (matched related allogeneic HSCT) using a non-T cell depleted graft under standard of care procedures |
| DLI | GENETIC | Allogeneic donor lymphocyte infusion (DLI) starting dose not to exceed 10\^6/m\^2 intravenously between 6 weeks and 12 weeks following allogeneic HSCT. |
Inclusion Criteria: 1. Patients with a history of CD19+ lymphoid malignancies that are primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease. Patients in first remission...