Induction Chemotherapy (R-CHOP Vs. R-FC) Followed by Interferon Maintenance Versus Rituximab Maintenance in MCL (MCLelderly)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by European Mantle Cell Lymphoma Network
Sponsor:
Collaborators:
German Low Grade Lymphoma Study Group
Lymphoma Study Association
HOVON - Dutch Haemato-Oncology Association
Nordic Lymphoma Group
Information provided by (Responsible Party):
Dr. M. Dreyling (co-chairman), European Mantle Cell Lymphoma Network
ClinicalTrials.gov Identifier:
NCT00209209
First received: September 13, 2005
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

The aim of this study is to answer the following independent questions in the treatment of mantle cell lymphomas:

  • Can rituximab-fludarabine, cyclophosphamide (R-FC) improve the reduction of lymphoma mass compared to rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) and so become a new standard for initial cytoreductive therapy?
  • Can maintenance with rituximab substitute the interferon maintenance and even improve the progression free survival in patients after successful initial cytoreductive therapy?

Condition Intervention Phase
Lymphoma, Mantle-Cell
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Drug: Fludarabine
Drug: Interferon-alpha
Drug: pegylated formula Interferon-alpha 2b
Procedure: chemotherapy: R-CHOP
Procedure: chemotherapy: R-FC
Procedure: Interferon maintenance
Procedure: Rituximab maintenance
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 Maintenance Therapy With Rituximab After Induction Chemotherapy (R-CHOP vs. R-FC) for Elderly Patients With Mantle Cell Lymphoma Not Suitable for Autologous Stem Cell Transplantation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • First randomisation: Reduction of lymphoma mass measured by the complete remission (CR) rate
  • Second randomisation: progression-free survival after end of initial chemotherapy

Secondary Outcome Measures:
  • Survival after registration / first randomisation / second randomisation
  • Survival after start / end of initial therapy
  • Time to treatment failure after start of initial therapy
  • Progression free survival after registration / first randomisation / second randomisation
  • Side-effects of initial therapy
  • Side-effects of maintenance therapy

Estimated Enrollment: 570
Study Start Date: January 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
  1. randomisation: R-CHOP
  2. randomisation: IFN maintenance
Drug: Rituximab
antibody
Drug: Cyclophosphamide
chemotherapy
Drug: Doxorubicin
chemotherapy
Drug: Vincristine
chemotherapy
Drug: Prednisone
coricosteroide
Drug: Interferon-alpha
cytokine
Drug: pegylated formula Interferon-alpha 2b
cytokine
Procedure: chemotherapy: R-CHOP
immuno-chemotherapy
Procedure: Interferon maintenance
cytokine
Experimental: 2
  1. randomisation: R-FC
  2. randomisation: Rituximab maintnenance
Drug: Rituximab
antibody
Drug: Cyclophosphamide
chemotherapy
Drug: Fludarabine
chemotherapy
Procedure: chemotherapy: R-FC
immuno-chemotherapy
Procedure: Rituximab maintenance
antibody

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven mantle cell lymphoma according to the World Health Organization (WHO) classification, preferably confirmed by central pathology review before entering the study
  • Clinical stage II, III or IV
  • Previously untreated patients
  • Above the age of 65 years and older or patients at the age between 60 and 65, if not eligible for high dose chemotherapy
  • WHO performance grade 0, 1 or 2
  • 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
  • Measurable disease. If, for example only bone marrow (BM) infiltration, patients can only undergo a second randomization if a CR is obtained.

Exclusion Criteria:

  • WHO performance of 3 or more
  • Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
  • Leukocytes <2.0x 10^9/l or thrombocytes <100x 10^9/l, unless clearly related to mantle cell lymphoma (MCL) bone marrow infiltration
  • Patients previously treated for lymphoma
  • Patients without measurable lesions; if, for example only bone marrow infiltration, patients may be included, but can only undergo a second randomization in case of a CR
  • Patients with stage I disease
  • Patients with central nervous system involvement
  • Patients with a history of autoimmune hemolytic anaemia or autoimmune thrombocytopenia
  • Patients with serious cardiac disease (uncontrolled arrhythmias, unstable angina, severe congestive heart failure)
  • Patients with serious pulmonary, neurological, endocrinological or other disorder interfering with full dosing of CHOP or FC chemotherapy
  • Liver enzymes >3x normal or bilirubin >2.5x normal (not due to lymphoma)
  • Creatinine >2x normal value, corrected for age and weight (not due to lymphoma)
  • Patients with unresolved hepatitis B or C infection or known HIV positive infection
  • Uncontrolled infection
  • Patients with a serious depression that needed therapy within the last 5 years
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Concomitant or previous malignancies other than basal cell or squamous cell skin cancer, in situ cervical cancer and other cancer for which the patient has been disease-free for at least 5 years
  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: NCT00209209

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
Czech Republic
General University Hospital, 1St Department of Medicine Recruiting
Praha, Czech Republic, CZ-12808
Contact: Marek Trnény, MD    0042-2-2496-2061    trneny@cesnet.cz   
Principal Investigator: Marek Trnény, MD         
Denmark
Nordic Lymphoma Group Recruiting
Copenhagen, Denmark, DK-2100
Contact: Christian Geisler, MD    +45-3545-1146    geisler@rh.dk   
Principal Investigator: Christian Geisler, MD         
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: Martin Dreyling, PhD         
Italy
Ospedale Ferratotto, Divisione Di Ematologia Recruiting
Catania, Italy, I-95124
Contact: Francesco Di Raimondo, PhD    +39-095-7435911      
Principal Investigator: Francesco Di Raimondo, PhD         
Netherlands
HOVON - Dutch Haemato-Oncology Association (HOVON-Datacenter) Recruiting
Rotterdam, Netherlands, NL-3008 AE
Contact: Christel van Hooije    +31-10-4391568      
Contact: Hanneke C. Kluin-Nelemans, PhD    +31-50-3612354    j.c.kluin.nelemans@int.azg.nl   
Principal Investigator: Hanneke C. Kluin-Nelemans, 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
HOVON - Dutch Haemato-Oncology Association
Nordic Lymphoma Group
Investigators
Principal Investigator: Hanneke C. Kluin-Nelemans, PhD University Hospital Groningen, Dept. of Hematology
Study Chair: Martin Dreyling, PhD University Hospital Grosshadern/LMU, Dept. of Medicine III
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. M. Dreyling (co-chairman), Professor of Medicine, European Mantle Cell Lymphoma Network
ClinicalTrials.gov Identifier: NCT00209209     History of Changes
Other Study ID Numbers: MCL2004-1
Study First Received: September 13, 2005
Last Updated: September 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by European Mantle Cell Lymphoma Network:
Lymphoma, Mantle-Cell
Elderly patients
Chemotherapy
Maintenance 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
Interferon-alpha
Interferons
Rituximab
Alkylating Agents
Anti-Infective Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014