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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01538472 | Y Zevalin and BEAM in Autologous Stem Cell Transplantation (ASCT) for Lymphoma | PHASE1 | COMPLETED | 40 | — | — | Sep 1, 2003 | Nov 1, 2011 | Sep 11, 2014 | 1 | United States |
Overall survival reported as number of days participants alive following treatment up to 5 years with annual follow up till disease progression. Evaluations done every 3 months for 1 year and then every 6 months for 5 years to check on the status of the disease, with long-term follow up as needed.
Number of participants alive 3 years following treatment. Evaluations done every 3 months for 1 year and then every 6 months to check on the status of the disease.
| Arm | Type | Description |
|---|---|---|
| Y Zevalin + BEAM | EXPERIMENTAL | Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation. G-CSF 5 mg/kg given daily starting Day 0 till recovery of granulocytes of 4.0 \* 109/L. |
| Name | Type | Description |
|---|---|---|
| Y Zevalin | DRUG | Starting dose: 0.4 mCi/kg by vein after Rituxan infusion on Day -14. |
| In Zevalin | DRUG | Imaging dose: 5 mCi by vein following Rituxan infusion on Day -21. |
| Rituxan | DRUG | 250 mg/m2 by vein on Day -21 and on Day -14. 1000 mg/m2 by vein on Days +1 and +8. |
| BCNU | DRUG | 300 mg/m2 by vein on Day -6. |
| VP -16 | DRUG | 200 mg/m2 by vein every 12 hours on Days -5, -4, -3, and -2. |
| Ara-C | DRUG | 200 mg/m2 by vein every 12 hours on Days -5, -4, -3,and -2. |
| Melphalan | DRUG | 140 mg/m2 by vein on Day -1. |
| Stem Cell Infusion | PROCEDURE | Autologous stem cell infusion on Day 0. |
| G-CSF | DRUG | 5 mg/kg by vein daily starting Day 0 till recovery of granulocytes of 4.0 x 109/L. |
Inclusion Criteria: 1. Relapsed CD20-positive B-cell non-Hodgkin's lymphoma (NHL) (demonstrated in lymph nodes or bone marrow), chemosensitive (at least Partial Remission (PR)). 2. No anti-cancer therapy started within three weeks, prior to study initiation, and fully recovered from all toxicities ...