Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma
Recruitment status was: Active, not recruiting
Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide, and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be assessed.
- Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma.
- Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated with clinical response to RT-PEPC therapy.
- Assess the quality of life of patients receiving RT-PEPC treatment
|Non-Hodgkin's Lymphoma||Drug: Rituximab, Thalidomide, Prednisone, Etoposide, Procarbazine, Cyclophosphamide||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma|
- effect of drug combination on mantle cell lymphoma [ Time Frame: duration of study ]
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Drug: Rituximab, Thalidomide, Prednisone, Etoposide, Procarbazine, Cyclophosphamide
- PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.
- Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.
- Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.
- Daily low dose thalidomide (50-100 mg/d)
- PEPC QOD or fractionated weekly basis.
- Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.
- Daily low dose thalidomide (50-100mg/d)
- PEPC QOD or fractionated weekly basis
- Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months
Induction phase (month 1-3)
Maintenance phase (month 4-12)
Post-Month 12 Maintenance phase (post-month 12 until disease progression)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151281
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||John P Leonard, MD||Weill Medical College of Cornell University|