R-CHOP-B Bevacizumab for Diffuse Large B Cell Lymphoma

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT00788606
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab, Rituximab — DRUG
    6 cycles of treatment. Bevacizumab at a dose of 15 mg/kg, diluted in normal saline will be administered as a intravenous infusion over 30 to 90 minutes on Day 1 of each cycle. Rituzimab 375 mg/m2 is given as a intravenous infusion after the administration of prednisolone and before the other cytotoxic drugs on Day 1 of each cycle.

Study Details

This study evaluates the use of the standard treatment R-CHOP plus the anti-VEGF drug, bevacizumab and whether this treatment is feasible in patients with stage II, III and IV diffuse large B cell lymphoma (DLBCL).

Key Dates

First listed
Nov 11, 2008
Start date
May 31, 2008
Status verified
Oct 2016
Primary completion
Jun 30, 2010
Completion
Jun 30, 2010

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: bevacizumab and Rituximab
    This study evaluates the feasibility using the anti-VEGF drug, bevacizumab, in combination with the standard treatment Rituximab in patients with stage II, III and IV diffuse large B cell lymphoma (DLBCL)

Primary Outcome Measure

The primary endpoint of this study is cardiac and bevacizumab-specific toxicity. Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events v3.0 [ Time Frame: 1 year ]

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