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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00968760 | CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies | PHASE1 | COMPLETED | 34 | — | — | Jun 20, 2011 | Apr 23, 2020 | Dec 19, 2023 | 1 | United States |
The MTD is the highest dose at which at least 6 participants treated with the proportion of participants having dose limiting toxicities (DLT) \< 1/3. DLT is defined as a new adverse event of grade \>3 involving cardiopulmonary, gastrointestinal, hepatic (excluding albumin), neurological, or renal Common Terminology Criteria for Adverse Events (CTCAE) version 4 parameters that is probably or definitely related to the infused T-cell product.
| Arm | Type | Description |
|---|---|---|
| CD19-specific T cell Infusion without IL-2 | EXPERIMENTAL | Conditioning Regimen of Chemotherapy (Carmustine, Cytarabine, Etoposide, and Melphalan), Stem Cell Transplant, and Gene Transfer Group 1 - low dose of T cells without IL-2. Group 3 - higher dose of T cells without IL-2. |
| CD19-specific T cell Infusion with IL-2 | EXPERIMENTAL | Conditioning Regimen of Chemotherapy (Carmustine, Cytarabine, Etoposide, and Melphalan), Stem Cell Transplant, and Gene Transfer Group 2 - higher dose of T cells with IL-2. Group 4 - higher dose of T cells with IL-2. |
| Name | Type | Description |
|---|---|---|
| Leukapheresis | PROCEDURE | Leukapheresis #1 - For Collecting T Cells Leukapheresis #2 - For Collecting Stem Cells, month following #1 Blood drawn through vein, passed through a machine to collect specific blood cells, then remaining blood returned, about 3 hours to complete. |
| Stem Cell Transplant | PROCEDURE | Stem cell infusion by vein over 30-45 minutes on Day 0 |
| CD19-specific T Cell Infusion | PROCEDURE | T Cell Infusion (Gene Transfer) by vein over 15-30 minutes sometime between Day +2 through Day +7. |
| IL-2 | DRUG | Group 2 or 4, IL-2 dose of 0.3 x 10\^6 U/m\^2 injected under skin, once a day for up to 14 days; first dose on day of T cell infusion. |
| Carmustine | DRUG | 300 mg/m\^2 IV over 1 hour on Day -6 |
| Etoposide | DRUG | 200 mg/m\^2 IV over 3 hours every 12 hours on Days -5 to -2 |
| Cytarabine | DRUG | 200 mg/m\^2 by vein over 1 hour every 12 hours on Days -5 to -2. |
| Melphalan | DRUG | 140 mg/m\^2 IV over 30 minutes on Day -1 |
Inclusion Criteria: 1. Patients with a history of CD19+ lymphoid malignancies that are beyond first remission or primary refractory to treatment. 2. Age 18 to 75 years. 3. Zubrod performance 0-1 or Karnofsky greater than or equal to 80%. 4. Patient able to provide written informed consent. 5. Patie...