Efficacy of R-CHOP vs R-CHOP/R-DHAP in Untreated MCL
Efficacy of 6x R-CHOP Followed by Myeloablative Radiochemotherapy and Autologous Stem Cell Transplantation vs. 3 x (R-CHOP/R-DHAP) Followed by a High Dose ARA-C Containing Myeloablative Regimen and Autologous Stem Cell Transplantation
1 other identifier
interventional
360
3 countries
3
Brief Summary
The aim of this study is to determine whether alternating courses of cyclophosphamide, doxorubicin, vincristine, prednisone/dexamethasone, cytarabine, cisplatin (CHOP/DHAP) plus rituximab followed by total body irradiation \[TBI\]/high dose cytarabine \[ARA-C\]/melphalan-peripheral blood stem cell transplantation (TAM-PBSCT) can improve the time to treatment failure compared to CHOP plus rituximab followed by standard PBSCT (dexamethasone, carmustine, cytarabine, etoposide, and melphalan \[Dexa-BEAM\]/TBI/high dose cyclophosphamide) in patients with untreated mantle cell lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2004
Longer than P75 for phase_3
3 active sites
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
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 10, 2012
July 1, 2009
10.4 years
September 13, 2005
September 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to treatment failure after start of therapy
Secondary Outcomes (5)
complete remission (CR) rate
overall survival
progression-free survival
adverse events
serious infectious complications
Study Arms (2)
1
ACTIVE COMPARATORinduction: R-CHOP consoldiation : TBI/Cyclo
2
EXPERIMENTALinduction: R-CHOP/DHAP consolditaion: TBI/TAM
Interventions
Eligibility Criteria
You may qualify if:
- Histologically proven diagnosis of mantle cell lymphoma (World Health Organization \[WHO\] classification)
- Clinical stage II - IV (Ann Arbor)
- Previously untreated patients
- Age 18 - 65 years
- WHO performance \< 2
- Measurable disease (also: patients with isolated bone marrow involvement)
- Informed consent according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/European Union Good Clinical Practice (ICH/EU GCP) and national/local regulations
You may not qualify if:
- Age \> 65 years
- WHO performance status \> 2
- Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
- Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon
- Serious disease interfering with a regular therapy according to the study protocol:
- cardiac (e.g. manifest heart failure, coronary heart disease, uncontrolled hypertension)
- pulmonary (e.g. chronic lung disease with hypoxemia)
- endocrine (e.g. severe, not sufficiently controlled diabetes mellitus)
- renal insufficiency (unless caused by the lymphoma): creatinine \> 2x normal value and/or creatinine clearance \< 50 ml/min)
- impairment of liver function (unless caused by the lymphoma): transaminases \> 3x normal or bilirubin \> 2,0 mg/dl
- Patients with unresolved hepatitis B or C infection or known HIV infection
- Prior organ, bone marrow or peripheral blood stem cell transplantation
- Concomitant or previous malignancies within the last 5 years other than basal cell skin cancer or in situ uterine cervix cancer.
- Pregnancy or lactation
- Any psychological, familiar, sociological, or geographical condition potentially hampering compliance with the study protocol and follow up schedule
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- European Mantle Cell Lymphoma Networklead
- German Low Grade Lymphoma Study Groupcollaborator
- Lymphoma Study Associationcollaborator
Study Sites (3)
Groupe D´Etudes des Lymphomes De l´Adulte (GELA)
Paris, F-75743, France
German Low Grade Study Group (Glsg)
Munich, D-81377, Germany
The Maria Sklodowska Memorial, Cancer Center - Inst. of Oncology
Warsaw, PL-02-781, Poland
Related Publications (7)
Dreyling M, Lenz G, Hoster E, Van Hoof A, Gisselbrecht C, Schmits R, Metzner B, Truemper L, Reiser M, Steinhauer H, Boiron JM, Boogaerts MA, Aldaoud A, Silingardi V, Kluin-Nelemans HC, Hasford J, Parwaresch R, Unterhalt M, Hiddemann W. Early consolidation by myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission significantly prolongs progression-free survival in mantle-cell lymphoma: results of a prospective randomized trial of the European MCL Network. Blood. 2005 Apr 1;105(7):2677-84. doi: 10.1182/blood-2004-10-3883. Epub 2004 Dec 9.
PMID: 15591112BACKGROUNDLenz G, Dreyling M, Hoster E, Wormann B, Duhrsen U, Metzner B, Eimermacher H, Neubauer A, Wandt H, Steinhauer H, Martin S, Heidemann E, Aldaoud A, Parwaresch R, Hasford J, Unterhalt M, Hiddemann W. Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves response and time to treatment failure, but not long-term outcome in patients with previously untreated mantle cell lymphoma: results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005 Mar 20;23(9):1984-92. doi: 10.1200/JCO.2005.08.133. Epub 2005 Jan 24.
PMID: 15668467BACKGROUNDHermine O, Jiang L, Walewski J, Bosly A, Thieblemont C, Szymczyk M, Pott C, Salles G, Feugier P, Hubel K, Haioun C, Casasnovas RO, Schmidt C, Bouabdallah K, Ribrag V, Kanz L, Durig J, Metzner B, Sibon D, Cheminant M, Burroni B, Klapper W, Hiddemann W, Unterhalt M, Hoster E, Dreyling M; European Mantle Cell Lymphoma Network. High-Dose Cytarabine and Autologous Stem-Cell Transplantation in Mantle Cell Lymphoma: Long-Term Follow-Up of the Randomized Mantle Cell Lymphoma Younger Trial of the European Mantle Cell Lymphoma Network. J Clin Oncol. 2023 Jan 20;41(3):479-484. doi: 10.1200/JCO.22.01780. Epub 2022 Dec 5.
PMID: 36469833DERIVEDHermine O, Hoster E, Walewski J, Bosly A, Stilgenbauer S, Thieblemont C, Szymczyk M, Bouabdallah R, Kneba M, Hallek M, Salles G, Feugier P, Ribrag V, Birkmann J, Forstpointner R, Haioun C, Hanel M, Casasnovas RO, Finke J, Peter N, Bouabdallah K, Sebban C, Fischer T, Duhrsen U, Metzner B, Maschmeyer G, Kanz L, Schmidt C, Delarue R, Brousse N, Klapper W, Macintyre E, Delfau-Larue MH, Pott C, Hiddemann W, Unterhalt M, Dreyling M; European Mantle Cell Lymphoma Network. Addition of high-dose cytarabine to immunochemotherapy before autologous stem-cell transplantation in patients aged 65 years or younger with mantle cell lymphoma (MCL Younger): a randomised, open-label, phase 3 trial of the European Mantle Cell Lymphoma Network. Lancet. 2016 Aug 6;388(10044):565-75. doi: 10.1016/S0140-6736(16)00739-X. Epub 2016 Jun 14.
PMID: 27313086DERIVEDDelfau-Larue MH, Klapper W, Berger F, Jardin F, Briere J, Salles G, Casasnovas O, Feugier P, Haioun C, Ribrag V, Thieblemont C, Unterhalt M, Dreyling M, Macintyre E, Pott C, Hermine O, Hoster E; European Mantle Cell Lymphoma Network. High-dose cytarabine does not overcome the adverse prognostic value of CDKN2A and TP53 deletions in mantle cell lymphoma. Blood. 2015 Jul 30;126(5):604-11. doi: 10.1182/blood-2015-02-628792. Epub 2015 May 28.
PMID: 26022239DERIVEDHoster E, Klapper W, Hermine O, Kluin-Nelemans HC, Walewski J, van Hoof A, Trneny M, Geisler CH, Di Raimondo F, Szymczyk M, Stilgenbauer S, Thieblemont C, Hallek M, Forstpointner R, Pott C, Ribrag V, Doorduijn J, Hiddemann W, Dreyling MH, Unterhalt M. Confirmation of the mantle-cell lymphoma International Prognostic Index in randomized trials of the European Mantle-Cell Lymphoma Network. J Clin Oncol. 2014 May 1;32(13):1338-46. doi: 10.1200/JCO.2013.52.2466. Epub 2014 Mar 31.
PMID: 24687837DERIVEDPott C, Hoster E, Delfau-Larue MH, Beldjord K, Bottcher S, Asnafi V, Plonquet A, Siebert R, Callet-Bauchu E, Andersen N, van Dongen JJ, Klapper W, Berger F, Ribrag V, van Hoof AL, Trneny M, Walewski J, Dreger P, Unterhalt M, Hiddemann W, Kneba M, Kluin-Nelemans HC, Hermine O, Macintyre E, Dreyling M. Molecular remission is an independent predictor of clinical outcome in patients with mantle cell lymphoma after combined immunochemotherapy: a European MCL intergroup study. Blood. 2010 Apr 22;115(16):3215-23. doi: 10.1182/blood-2009-06-230250. Epub 2009 Dec 23.
PMID: 20032498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier Hermine, PhD
University Hospital Necker, Dept. of Adult Hematology
- STUDY CHAIR
Wolfgang Hiddemann, PhD
University Hospital Großhadern/LMU, Dept. of Medicine III
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
July 1, 2004
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
September 10, 2012
Record last verified: 2009-07