Clinical trial · Interventional
Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma
A Randomized Phase III Study to Compare Conventional Chemotherapy (CHOEP-14) + Rituximab vs High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation (Mega-CHOEP-21) + Rituximab in Younger Patients With Aggressive NHL
NCT00129090CI-TRIAL-00066690completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-CHOEP 14 with 12x Rituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-CHOEP14 with 12x Rituximab
- description
- 8 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 )
- interventionNames
- Drug: R-CHOEP 14 with 12x Rituximab
Primary outcomes (1)
- measure
- time to treatment failure
- timeFrame
- 3 years after study inclusion
- description
- At 3 year follow up rate of treatments and time to treatment failure will be determined
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 18-60 years of age * Risk group International Prognostic Index (IPI) 2 and 3 (age adjusted) * Performance status: Eastern Cooperative Oncology Group (ECOG) 0-3 * Patient's written informed consent * Aggressive non-Hodgkin's lymphoma with CD20+ histology Exclusion Criteria: * Already initiated lymphoma therapy * Serious accompanying disorder or impaired organ function * Bone marrow involvement \> 25% * Known hypersensibility to the medications to be used * Known HIV-positivity * Active hepatitis infection * Suspicion that patient compliance will be poor * Simultaneous participation in other trials * Prior chemo- or radiotherapy for previous disorder * Other concomitant tumour disease
References
Publications (3)
- DERIVEDOertel M, Ziepert M, Frontzek F, Nacke N, Altmann B, Nickelsen M, Glass B, Poeschel V, Ruebe C, Lenz G, Schmitz N, Eich HT. Radiotherapy in younger patients with advanced aggressive B-cell lymphoma-long-term results from the phase 3 R-MegaCHOEP trial. Leukemia. 2024 May;38(5):1099-1106. doi: 10.1038/s41375-024-02231-9. Epub 2024 Mar 27. PMID 38538861
- DERIVEDFrontzek F, Ziepert M, Nickelsen M, Altmann B, Glass B, Haenel M, Truemper L, Held G, Bentz M, Borchmann P, Dreyling M, Viardot A, Kroschinsky FP, Metzner B, Staiger AM, Horn H, Ott G, Rosenwald A, Loeffler M, Lenz G, Schmitz N. Rituximab plus high-dose chemotherapy (MegaCHOEP) or conventional chemotherapy (CHOEP-14) in young, high-risk patients with aggressive B-cell lymphoma: 10-year follow-up of a randomised, open-label, phase 3 trial. Lancet Haematol. 2021 Apr;8(4):e267-e277. doi: 10.1016/S2352-3026(21)00022-3. Epub 2021 Mar 2. PMID 33667420
- DERIVEDSchmitz N, Nickelsen M, Ziepert M, Haenel M, Borchmann P, Schmidt C, Viardot A, Bentz M, Peter N, Ehninger G, Doelken G, Ruebe C, Truemper L, Rosenwald A, Pfreundschuh M, Loeffler M, Glass B; German High-Grade Lymphoma Study Group (DSHNHL). Conventional chemotherapy (CHOEP-14) with rituximab or high-dose chemotherapy (MegaCHOEP) with rituximab for young, high-risk patients with aggressive B-cell lymphoma: an open-label, randomised, phase 3 trial (DSHNHL 2002-1). Lancet Oncol. 2012 Dec;13(12):1250-9. doi: 10.1016/S1470-2045(12)70481-3. Epub 2012 Nov 16. PMID 23168367