Status:
UNKNOWN
Efficacy of R-CHOP vs R-CHOP/R-DHAP in Untreated MCL
Lead Sponsor:
European Mantle Cell Lymphoma Network
Collaborating Sponsors:
German Low Grade Lymphoma Study Group
Lymphoma Study Association
Conditions:
Lymphoma, Mantle-Cell
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ...
Detailed Description
Recently, a prospective randomized intergroup trial of the European MCL Network has shown that a myeloablative radio-chemotherapy followed by autologous stem cell transplantation (PBSCT) improves even...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00209222
Start Date
July 1 2004
End Date
December 1 2014
Last Update
September 10 2012
Active Locations (3)
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1
Groupe D´Etudes des Lymphomes De l´Adulte (GELA)
Paris, France, F-75743
2
German Low Grade Study Group (Glsg)
Munich, Germany, D-81377
3
The Maria Sklodowska Memorial, Cancer Center - Inst. of Oncology
Warsaw, Poland, PL-02-781