Avastin Plus Rituximab for Patients With B-Cell Non-Hodgkin's Lymphoma

This study has been completed.

Study NCT00081861 Information provided by M.D. Anderson Cancer Center

First Received: April 23, 2004 Last Updated: July 17, 2009 History of Changes

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Condition:	Lymphoma
Interventions:	Drug: Avastin Drug: Rituximab

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: April 2004 through November 2006. All participants recruited at U.T. M.D. Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Avastin + Rituximab	No text entered.

Participant Flow: Overall Study

	Avastin + Rituximab
STARTED	13
COMPLETED	13^[1]
NOT COMPLETED	0

[1]	2 participants received first treatment dose but were not eligible for response due to toxicity.

Baseline Characteristics

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Reporting Groups

	Description
Avastin + Rituximab	No text entered.

Baseline Measures

	Avastin + Rituximab
Number of Participants [units: participants]	13
Age [units: years] Median ( Full Range )	67 ( 34 to 79 )
Gender [units: participants]
Female	6
Male	7
Region of Enrollment [units: Participants]
United States	13

Outcome Measures

1. Primary:

Number of Participants With Response (Complete Response or Progressive Disease) [ After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab), ]

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Measure Type	Primary
Measure Title	Number of Participants With Response (Complete Response or Progressive Disease)
Measure Description	Response measured from first documentation of response to first detection of progression. Response criteria is according to the International Working Group Recommendations for lymphoma.
Time Frame	After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab),
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Avastin + Rituximab	No text entered.

Measured Values

	Avastin + Rituximab
Number of Participants Analyzed [units: participants]	13
Number of Participants With Response (Complete Response or Progressive Disease) [units: Participants]
Complete Response	2
Less Than Complete Response	2
Progressive Disease	7
Not Evaluated	2

No statistical analysis provided for Number of Participants With Response (Complete Response or Progressive Disease)

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Barbara Pro, MD / Associate Professor
Organization: U.T. M.D. Anderson Cancer Center
phone: 713-792-2860

No publications provided

Responsible Party:	U.T. M.D. Anderson Cancer Center ( Barbara Pro, MD / Associate Professor )
Study ID Numbers:	2003-0520
Study First Received:	April 23, 2004
Results First Received:	March 5, 2009
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00081861 History of Changes
Health Authority:	United States: Food and Drug Administration