Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma

Conditions

Non-Hodgkin's Lymphoma (NHL)

Brief summary

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)

Detailed description

This study was primarily designed to compare aggressive conventional chemotherapy with a repetitive high-dose (HD) therapy program using identical, effective drugs at highest possible dose and dose intensity with/without addition of rituximab (initially 4 treatment arms). In 2004 the first amendment had to be added in order to close two treatment arms without rituximab due to recent data revealing a significant advantage for rituximab-treated patients with CD20+lymphoma. A planned interim analysis in 2010 revealed inferiority of the high-dose treatment thus in the 2nd amendment the high-dose arm was closed and additionally the rituximab frequency was raised from 6 to 12 administrations as recent publications gave hint for advantage. The last amendment was added in 2010 to adjust for delayed recruitment mainly due to organisation problems. As the high-dose arm was closed only CD20+ B-lymphoma were included past amendment 2.

Oertel M, Ziepert M, Frontzek F, Nacke N, Altmann B, Nickelsen M, Glass B, Poeschel V, Ruebe C, Lenz G, Schmitz N, Eich HT.

2024-03-274 citations

10.1038/s41375-024-02231-9

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.

Frontzek 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.

2021-03-0227 citations

10.1016/s2352-3026(21)00022-3

Adding Etoposide to R-CHOP (R-CHOEP) Does Not Significantly Increase the Risk of Secondary Neoplasms in Patients with Aggressive B-Cell Lymphoma - Results from Randomized Phase 3 Trials of the German Lymphoma Alliance (GLA)

Fabian Frontzek, Marita Ziepert, Maike Nickelsen, Bettina Altmann, Bertram Glaß et al. (21 authors)

Blood2020-11-04

10.1182/blood-2020-138412

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).

Schmitz 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).

2012-11-16179 citations

10.1016/s1470-2045(12)70481-3

Interventions

DRUGR-CHOEP 14 with 12x Rituximab

after 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 design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
time to treatment failure	3 years after study inclusion	At 3 year follow up rate of treatments and time to treatment failure will be determined

Countries

Germany

Outcome results

None listed