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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02529813 | CD19-Specific T-cells in Treating Patients With Advanced Lymphoid Malignancies | PHASE1 | COMPLETED | 26 | — | — | Dec 16, 2015 | Nov 8, 2021 | Jun 30, 2022 | 1 | United States |
Will be defined as the highest dose for which the posterior probability of toxicity is closest to 25%. Demographic and clinical characteristics will be summarized using descriptive statistics by dose level. The number of patients with dose limiting toxicities will be reported at each dose level.
| Arm | Type | Description |
|---|---|---|
| Arm I (CD19 positive chimeric antigen receptor T-cells) | EXPERIMENTAL | LYMPHODEPLETING CHEMOTHERAPY: Patients may receive standard chemotherapy comprised of fludarabine phosphate IV over 1 hour and cyclophosphamide IV over 3 hours on days -5 to -3 or cyclophosphamide IV every 12 hours on days -5 to -3 at the discretion of the treating physician. Within 30 days post completion of lymphodepletion, patients receive CD19 positive chimeric antigen receptor T-cells IV over 15-30 minutes on day 0, or split into two portions on days 0 and 1. |
| Name | Type | Description |
|---|---|---|
| Cyclophosphamide | DRUG | Given IV |
| Fludarabine Phosphate | DRUG | Given IV |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Tisagenlecleucel | BIOLOGICAL | Given IV |
Inclusion Criteria: * Patients with a history of CD19+ lymphoid malignancy defined as acute lymphoblastic leukemia, acute biphenotypic leukemia, non-Hodgkin's lymphoma, small lymphocytic lymphoma, or chronic lymphocytic leukemia with active disease defined by presence of \> 5% malignant blasts in b...