EUCTR2008-008202-52-PT
Active, not recruiting
Phase 1
DOUBLE BLIND RANDOMIZED PHASE III STUDY OF LENALIDOMIDE (REVLIMID®) MAINTENANCE VERSUS PLACEBO IN RESPONDING ELDERLY PATIENTS WITH DLBCL AND TREATED WITH R-CHOP IN FIRST LINE - REMARC
YSARC0 sites650 target enrollmentJuly 27, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- YSARC
- Enrollment
- 650
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For patients registered at the time of initial diagnosis:
- •Patient with histologically proven CD20\+ diffuse large B\-cell
- •lymphoma (DLBCL) (WHO classification 2008\) including clinical subtypes
- •(primitive mediastinal, intravascular, etc.). Patients with De Novo
- •Transformed DLBCL from low grade lymphoma (Follicular, other..) may
- •also be included. Patients with DLBCL associated with some small cell
- •infiltration in bone marrow may also be included
- •\- Or CD20\+ B\-cell lymphoma with intermediate features between DLBCL
- •and Burkitt or with intermediate features between DLBCL and classical
- •Hodgkin lymphoma
Exclusion Criteria
- •For all patients:
- •Any other histological type of lymphoma, Burkitt included.
- •Any history of treated or non\-treated small B\-cell lymphoma
- •Central nervous system or meningeal involvement by lymphoma
- •Contraindication to any drug contained in the chemotherapy regimen
- •For example: cardiac contra\-indication to anthracyclines (alteration of
- •Left Ventricular Function defined by LVEF\<50%) neurological
- •contraindication
- •to vincristine (peripheral neuropathy of WHO grade \= 2\).
- •Myocardial infarction during last 3 months or unstable coronary
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
STUDY OF LENALIDOMIDE IN MAINTENANCE VERSUS PLACEBO IN RESPONDING ELDERLY PATIENTS WITH B CELL LYMPHOMA AND PREVIOUSLY TREATED WITH R-CHOPDiffuse Large B Cell LymphomaMedDRA version: 14.1Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2008-008202-52-PLYSARC650
Active, not recruiting
Phase 1
STUDY OF LENALIDOMIDE IN MAINTENANCE VERSUS PLACEBO IN RESPONDING ELDERLY PATIENTS WITH B CELL LYMPHOMA AND PREVIOUSLY TREATED WITH R-CHOPEUCTR2008-008202-52-ATYSARC725
Active, not recruiting
Phase 1
STUDY OF LENALIDOMIDE IN MAINTENANCE VERSUS PLACEBO IN RESPONDING ELDERLY PATIENTS WITH B CELL LYMPHOMA AND PREVIOUSLY TREATED WITH R-CHOPDiffuse Large B Cell LymphomaMedDRA version: 20.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2008-008202-52-BEYSARC725
Active, not recruiting
Phase 3
Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With Diffuse Large B cell Lymphoma (DLBCL) and Treated With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)Diffuse large B cell lymphoma (DLBCL) in elderly patientsCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphomaACTRN12611000085976Australasian Leukaemia and Lymphoma Group54
Active, not recruiting
Phase 1
Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma.ntreated Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2010-022445-20-GRBristol-Myers Squibb International Corporation862