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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01959698 | Carfilzomib, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Stage I-IV Diffuse Large B-cell Lymphoma | PHASE1 | ACTIVE NOT_RECRUITING | 29 | — | — | Apr 17, 2014 | Dec 1, 2026 | Jan 28, 2026 | 1 | United States |
Overall response rate (CR and PR) after 3 cycles of C R ICE in patients age of 18 to 75 with relapsed/refractory CD20-positive DLBCL treated with rituximab-based immunochemotherapy (e.g., R-CHOP, R-EPOCH, R-HyperCVAD, etc.) induction. Response was based on a Modified Cheson Criteria with Complete response (CR): All lesions with a longest diameter ≤ 15 mm or short axis ≤ 10 mm (Not palpable during the clinical examination, No visible nodule on imaging, And disappearance of all non-nodal target lesions Or in case of hypermetabolic disease on the baseline PET scan, negative PET scan whatever the appearance of lesions on CT) and Partial Response (PR): ≥ 50 % of sum of the products of the diameters (SPD) of target lesions or in the case of hypermetabolic lesions on the baseline PET scan, persistence of at least one PET-positive site without progression of other lesions on CT (≥ 50 % of SPD of target lesions (or longest diameter if a single nodule) No clinically enlarged liver or spleen)
| Arm | Type | Description |
|---|---|---|
| Treatment (carfilzomib, rituximab, chemotherapy) | EXPERIMENTAL | Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Carboplatin | DRUG | Given IV |
| Carfilzomib | DRUG | Given IV |
| Etoposide | DRUG | Given IV |
| Ifosfamide | DRUG | Given IV |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Pharmacological Study | OTHER | Correlative studies |
| Rituximab | BIOLOGICAL | Given IV |
Inclusion Criteria: * Histological confirmation of relapsed/refractory CD20 positive diffuse large B-cell lymphoma * Ann Arbor stage I to stage IV DLBCL at the time of relapsed/refractory disease to be eligible * Measurable or assessable disease is required; measurable tumor size (at least one node...