Efficacy of R-CHOP vs R-CHOP/R-DHAP in Untreated MCL

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2009 by European Mantle Cell Lymphoma Network
Sponsor:
Collaborators:
German Low Grade Lymphoma Study Group
Lymphoma Study Association
Information provided by:
European Mantle Cell Lymphoma Network
ClinicalTrials.gov Identifier:
NCT00209222
First received: September 13, 2005
Last updated: September 7, 2012
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Lymphoma, Mantle-Cell
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Drug: Cisplatinum
Drug: Ara-C
Drug: Dexamethasone
Drug: BCNU
Drug: Melphalan
Drug: Etoposide
Drug: G-CSF
Procedure: chemotherapy: R-CHOP
Procedure: chemotherapy: R-DHAP
Procedure: chemotherapy: Dexa-BEAM
Procedure: stem cell harvest
Procedure: total body irradiation
Procedure: high-dose chemotherapy: Cyclophosphamide
Procedure: high-dose chemotherapy: Ara-C /Melphalan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by European Mantle Cell Lymphoma Network:

Primary Outcome Measures:
  • time to treatment failure after start of therapy

Secondary Outcome Measures:
  • complete remission (CR) rate
  • overall survival
  • progression-free survival
  • adverse events
  • serious infectious complications

Estimated Enrollment: 360
Study Start Date: July 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
induction: R-CHOP consoldiation : TBI/Cyclo
Drug: Rituximab
antibody
Drug: Cyclophosphamide
chemotherapy
Drug: Doxorubicin
chemotherapy
Drug: Vincristine
chemotherapy
Drug: Prednisone
corticosteroide
Drug: BCNU
chemotherapy
Drug: Melphalan
chemotherapy
Drug: Etoposide
chemotherapy
Drug: G-CSF
growth factor
Procedure: chemotherapy: R-CHOP
immuno-chemotherapy
Procedure: chemotherapy: Dexa-BEAM
chemotherapy
Procedure: stem cell harvest
procedure
Procedure: total body irradiation
radiation
Procedure: high-dose chemotherapy: Cyclophosphamide
chemotherapy
Experimental: 2
induction: R-CHOP/DHAP consolditaion: TBI/TAM
Drug: Rituximab
antibody
Drug: Cyclophosphamide
chemotherapy
Drug: Doxorubicin
chemotherapy
Drug: Vincristine
chemotherapy
Drug: Prednisone
corticosteroide
Drug: Cisplatinum
chemotherapy
Drug: Ara-C
chemotherapy
Drug: Dexamethasone
corticosteroide
Drug: Melphalan
chemotherapy
Drug: G-CSF
growth factor
Procedure: chemotherapy: R-CHOP
immuno-chemotherapy
Procedure: chemotherapy: R-DHAP
immuno-chemotherapy
Procedure: stem cell harvest
procedure
Procedure: total body irradiation
radiation
Procedure: high-dose chemotherapy: Ara-C /Melphalan
chemotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209222

Contacts
Contact: Michael Unterhalt, Dr. +49-89-7095 ext 4915 Michael.Unterhalt@med.uni-muenchen.de
Contact: Martin Dreyling, PhD +49-89-7095 ext 2202 Martin.Dreyling@med.uni-muenchen.de

Locations
France
Groupe D´Etudes des Lymphomes De l´Adulte (GELA) Recruiting
Paris, France, F-75743
Contact: Guylène Chartier    +33-1-42499811    Guylene.chartier@chu-stlouis.fr   
Contact: Olivier Hermine, PhD    +33-1-44 49 52 83    hermine@necker.fr   
Principal Investigator: Olivier Hermine, PhD         
Germany
German Low Grade Study Group (Glsg) Recruiting
Munich, Germany, D-81377
Contact: Michael Unterhalt, Dr.    +49-89-7095 ext 4915    Michael.Unterhalt@med.uni-muenchen.de   
Contact: Martin Dreyling, PhD    +49-89-7095 ext 2202    Martin.Dreyling@med.uni-muenchen.de   
Principal Investigator: Wolfgang Hiddemann, PhD         
Poland
The Maria Sklodowska Memorial, Cancer Center - Inst. of Oncology Recruiting
Warszawa, Poland, PL-02-781
Contact: Jan Walewski, MD    +48-22-546-2223    walewski@coi.waw.pl   
Contact: Marek P Nowacki, MD    +48-22-546-2223      
Principal Investigator: Jan Walewski, MD         
Sponsors and Collaborators
European Mantle Cell Lymphoma Network
German Low Grade Lymphoma Study Group
Lymphoma Study Association
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Dr. Martin Dreyling, University Hospital Grosshadern/European MCLNetwork
ClinicalTrials.gov Identifier: NCT00209222     History of Changes
Other Study ID Numbers: MCL2004-2
Study First Received: September 13, 2005
Last Updated: September 7, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by European Mantle Cell Lymphoma Network:
Lymphoma, Mantle-Cell
younger patients
chemotherapy
high dose therapy
C04.557.386.480.300.725.500
C15.604.515.569.480.300.725.500
C20.683.515.761.480.300.725.500

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Cytarabine
Dexamethasone
Melphalan
Alkylating Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Antiviral Agents
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 23, 2014