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Rituximab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immunologic Factors

In this group, the patients will receive regular Rituximab treatment accompanied with multiple NK immunotherapy. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

In this group, the patients will receive regular Rituximab to decrease tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Each time 10 billion cells, 4 times in all,i.v.

NK immunotherapy

Jibing Chen, MD, PhD

The aim of this study is the safety and efficacy of Rituximab plus NK immunotherapy to recurrent B lymphoma.

By enrolling patients with B lymphoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Rituximab and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Combination of Rituximab and NK Immunotherapy for B Lymphoma

It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)

Shenzhen Hank Bioengineering Institute

Fuda Cancer Hospital, Guangzhou

Lymphoma, Non-Hodgkin

Bortezomib

Rituximab -CHOP plus Velcade

christian Gisselbrecht, MD PHD

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

The association of the monoclonal antibody Rituximab to chemotherapy regimen of B-cell lymphoma is associated with an increase response rate and event free survival when compared to chemotherapy alone (Coiffier et al NEJM 2002). It has been observed in almost all histological type of B-cell lymphomas. No significant increase of toxicity was observed especially in the most used regimen CHOP and the association R-CHOP is a standard for most B-cell malignancies CD20 positive.

However, in patients with diffuse large cell lymphoma progress should be made as the complete response rate is below 75% in most situation and in low grade lymphoma, although patients respond well to chemotherapy complete remission rate averaged generally 50% (Marcus et al 2003), Czuczman et al 1999) .

There is a need to improve this association with new innovative agent. Before running randomized study it is important to evaluate the like hood of getting improvement by phase 2 study testing tolerance and efficacy on a well established regimen.

Bortezomib (Velcade formerly PS 341) is a proteasome inhibitor which has shown promising activity in the treatment of refractory myeloma. As single agent in indolent lymphomas, administered twice per weeks for 2 weeks followed by one week rest period it has already showed activity in phase 2 study. It is well tolerated and main toxicity was neuropathy and thrombocytopenia.

Proteasome inhibitors can act through multiple mechanisms to arrest tumor growth, tumor spread, and angiogenesis. In vitro studies have shown a synergistic effect of the association of Velcade and doxorubicin on myeloma cell lines resistant to chemotherapy.

Association of Velcade to standard chemotherapy regimen is under study with the aim of improving on the results.

Association of Velcade to one of the most efficient treatment of B-cell lymphoma, R-CHOP, might increase the response rate.

However, different schedules should be explored in order to better appreciate efficacy and toxicity.

This randomized phase 2 study is designed to evaluate the response rate and the toxicity of two schedules of administration of Velcade in association with R-CHOP. The aim of the study is to establish a well tolerated regimen giving a response rate in the limit upper/lower of what is observed with conventional R-CHOP used in all the different histological subtypes of B cell lymphomas patients requiring treatment.

The heterogeneity of the population will preclude any meaningful subgroup analysis.

It is important to evaluate tolerability before exploring the efficacy of this new regimen in large randomized studies or in specific phases II study which will need 50 patients for each subgroup of patients.

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

Association pour le Développement de la Recherche Clinique et Informatique en Onco-Hématologie

Lymphoma Study Association

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combination of Rituximab and NK Immunotherapy for B Lymphoma	NCT02843061	B-cell Lymphoma...	Rituximab NK immunotherap...	30 Years - 70 Years	Fuda Cancer Hospital, Guangzhou
Association of Velcade to R-CHOP in the Treatment of B Cell Lymphoma	NCT00169468	B Cell Lymphoma	Rituximab -CHOP...	18 Years - 80 Years	Lymphoma Study Association

Spots Global Cancer Trial Database for b lymphoma

Every month we try and update this database with for b lymphoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for b lymphoma

Every month we try and update this database with for b lymphoma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for b lymphoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.