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	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-Cell Lymphoma

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase I Treatment Closed 18 and over Pharmaceutical / Industry TCD10173
EudraCT 2007-003737-16, NCT00644124

Trial Description

Summary

The purpose of this study is to determine the selected dose of aflibercept when it is combined with R-CHOP treatment (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate) administered every 2 weeks or every 3 weeks, in non Hodgkin B-cell lymphoma, and to determine how the body handles aflibercept when it is administered with R-CHOP.

Eligibility Criteria

Inclusion Criteria:

Patients with non-Hodgkin B-cell lymphoma, good condition, not previously treated

Exclusion Criteria:

Contraindication to any drug contained in the R-CHOP (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate)

Less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of inclusion

Cerebral or leptomeningeal involvement.

History of another neoplasm (Adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for > 5 years are allowed)

Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to the first drug intake

Any acute or chronic medical condition, which could impair the ability of the patient to participate to the study or could interfere with interpretation of study results

Uncontrolled diabetes mellitus

Uncontrolled hypertension

Abnormal kidney function

Evidence of clinically significant bleeding diathesis, non-healing wound or underlying coagulopathy

Pregnant or breast-feeding woman, or patient with reproductive potential (male, female) without an effective method of contraception

History of hypersensitivity to any Trap agents or recombinant proteins

Trial Contact Information

Trial Lead Organizations/Sponsors

Sanofi-Aventis - US - Bridgewater

Regeneron Pharmaceuticals

Corinne Haioun, MD

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00644124
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.