Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma
- Sponsor
- German High-Grade Non-Hodgkin's Lymphoma Study Group
- Study ID
- NCT00129090
- Phase
- PHASE3
- Status
- Completed
Conditions
- Non-Hodgkin's Lymphoma (NHL)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- R-CHOEP 14 with 12x Rituximab — DRUGafter amendment 3 patients receive 4x 375mg/m2 in cycle 1 (day 0,1,4,8), 2x 375/m2 in cycle 2 (day1,8) and 1x 375mg/m2 cycle 3-8 (day 1 of each cycle)
Study Details
According to amendment 3 this study addresses the question if intensification of administration of rituximab in standard treatment for patients with newly diagnosed aggressive B-Non Hodgkin Lymphoma (B-NHL) and high risk (aaIPI 2 or 3) results in a better time to treatment failure (TTTF)
Key Dates
- Start date
- Mar 31, 2003
- Status verified
- May 2023
- Primary completion
- Oct 31, 2014
- Completion
- Oct 31, 2017
Study Design
- Enrollment
- 450 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: R-CHOEP14 with 12x Rituximab8 cycles of standard CHOP with etoposide in 14-day intervals. Patients with CD20+ lymphoma receive 12 doses of Rituximab (day 0,1,4,8 of cycle 1, day 1 and 8 of cycle 2, day1 of cycle 3-8 )
Primary Outcome Measure
time to treatment failure [ Time Frame: 3 years after study inclusion ]