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 on April 23, 2004. Last Updated on July 17, 2009 History of Changes

Results First Received: March 5, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
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) [ Time Frame: After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab), ]

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