Association of Velcade to R-CHOP in the Treatment of B Cell Lymphoma
Phase II Study of the Association of Velcade to R-CHOP in the Treatment of B Cell Lymphoma
1 other identifier
interventional
48
1 country
4
Brief Summary
The primary objective of this study is to evaluate the response rate and toxicity of the association R-CHOP with two schedules of administration of Velcade, in B-cell CD 20 + lymphoma patients, aged from 18 to 80 years The goal is to get a response rate at least at what observed with R-CHOP alone and will be evaluates with a sequential test. The other objective is to evaluate the toxicity
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2005
Shorter than P25 for phase_2
4 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
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedAugust 23, 2018
August 1, 2018
1 year
September 13, 2005
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of complete remission
1 year
Number of SAE
1 year
Secondary Outcomes (3)
Duration of response
1 year
Progression free survival
1 year
Overall survival
1 year
Interventions
Eligibility Criteria
You may qualify if:
- Patients with one of the following B-cell Lymphoma CD 20 positive : Mantle cell, Marginal zone, lymphocytic, follicular requiring treatment, Histological transformation from low grade to high grade, diffuse large cell without adverse prognostic factors defined by the international prognostic index (IPI)
- Aged from 18 to 80 years
- Untreated with chemotherapy except with Chlorambucil or Cyclophosphamide per os alone less than 6 months
- Previous radiotherapy except if localized
- Performance status \< 3
- Signed inform consent
You may not qualify if:
- Other type of lymphomas: Burkitt, T cell, CD 20 negative
- Central nervous system or meningeal involvement
- Contraindication to any drug contained in the chemotherapy regimen
- HIV disease, active hepatitis B or C
- Treatment with polychemotherapy before except with Chlorambucil or Cyclophosphamide per os less than 6 months
- Prior extended radiotherapy
- Any serious active disease or co-morbid medical condition (according to investigator's decision )
- Renal deficiency (clearance \< 30 ml/mn), liver deficiency (bilirubin \> 30 mmol/l) unless related to lymphoma
- Neuropathy\> grade 2 within 14 days before enrollment
- Platelets \< 30.109/l within 14 days before enrollment
- Neutrophils \< 1.0 109/l within 14 days before enrollment
- Women with pregnancy or without adequate method of contraception
- Any history of active cancer during the last two years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hôpital Saint-Louis
Paris, Paris 10, 75475, France
Institut Gustave Roussy
Villejuif, Villejuif Cedex, 94805, France
Hôpital Henri Mondor
Créteil, 94010, France
Hôpital Lyon Sud
Pierre-Bénite, 69310, France
Related Publications (4)
Czuczman MS, Grillo-Lopez AJ, White CA, Saleh M, Gordon L, LoBuglio AF, Jonas C, Klippenstein D, Dallaire B, Varns C. Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. J Clin Oncol. 1999 Jan;17(1):268-76. doi: 10.1200/JCO.1999.17.1.268.
PMID: 10458242BACKGROUNDCoiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.
PMID: 11807147BACKGROUND44. Marcus R, et al. (2003). An International Multi-Centre, Randomized, Open-Label, Phase III Trial Comparing Rituximab Added to CVP Chemotherapy to CVP Chemotherapy Alone in Untreated Stage III/IV Follicular Non-Hodgkins Lymphoma. Blood, 102, issue 11, (abstract 87).
BACKGROUNDO'Connor O, Wright J, Moskowitz CH, Muzzy J, MacGregor-Cortelli B, Hamlin P, Straus D, Trehu E, Schenkein DP, Zelenetz AD. Promising activity of the proteasome inhibitor bortezomib (VELCADE) in the treatment of indolent non-Hodgkin's lymphoma and mantle cell lymphoma: ASH poster session 517-II. J Natl Compr Canc Netw. 2004 Nov;2 Suppl 4:S21-2.
PMID: 19791425BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
christian Gisselbrecht, MD PHD
Lymphoma Study Association
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
January 1, 2005
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
August 23, 2018
Record last verified: 2018-08