NCT00129090

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2005

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

11.6 years

First QC Date

August 10, 2005

Last Update Submit

May 23, 2023

Conditions

Non-Hodgkin's Lymphoma (NHL)

Outcome Measures

Primary Outcomes (1)

  • time to treatment failure

    At 3 year follow up rate of treatments and time to treatment failure will be determined

    3 years after study inclusion

Study Arms (1)

R-CHOEP14 with 12x Rituximab

EXPERIMENTAL

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 )

Drug: R-CHOEP 14 with 12x Rituximab

Interventions

R-CHOEP 14 with 12x RituximabDRUG

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)

Also known as: 12 x Rituximab with 8 cycles of standard CHOEP-14
R-CHOEP14 with 12x Rituximab

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AK St. Georg

Hamburg, 20099, Germany

Location

Related Publications (3)

  • Oertel 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: 38538861DERIVED

  • 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. 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: 33667420DERIVED

  • 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). 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: 23168367DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Norbert Schmitz, Prof.

    German High-Grade Non-Hodgkin's Lymphoma Study Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2005

First Posted

August 11, 2005

Study Start

March 1, 2003

Primary Completion

October 1, 2014

Study Completion

October 1, 2017

Last Updated

May 25, 2023

Record last verified: 2023-05

Locations

DE(1)