Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage I, Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

This study has been completed.

Study NCT00049036 Information provided by AIDS Malignancy Clinical Trials Consortium

First Received on November 12, 2002. Last Updated on November 17, 2011 History of Changes

Results First Received: May 23, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Lymphoma
Interventions:	Biological: EPOCH + Concurrent rituximab Biological: EPOCH followed by 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
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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
EPOCH + Concurrent Rituximab	Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
EPOCH Followed by Rituximab	Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.

Participant Flow: Overall Study

	EPOCH + Concurrent Rituximab	EPOCH Followed by Rituximab
STARTED	51	55
COMPLETED	51	55
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
EPOCH + Concurrent Rituximab	Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
EPOCH Followed by Rituximab	Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.

Baseline Measures

	EPOCH + Concurrent Rituximab	EPOCH Followed by Rituximab	Total
Number of Participants [units: participants]	51	55	106
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	51	54	105
>=65 years	0	1	1
Age [units: years] Mean ± Standard Deviation	42.6 ± 8.4	42.6 ± 9.4	42.6 ± 8.9
Gender [units: participants]
Female	8	7	15
Male	43	48	91
Region of Enrollment [units: participants]
United States	51	55	106

Outcome Measures

1. Primary:

Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment [ Time Frame: 60 days ]

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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:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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: Jeannette Lee
Organization: AIDS Malignancy Consortium
phone: 501-526-6712
e-mail: jylee@uams.edu

Publications of Results:

Sparano JA, Lee JY, Kaplan LD, Levine AM, Ramos JC, Ambinder RF, Wachsman W, Aboulafia D, Noy A, Henry DH, Von Roenn J, Dezube BJ, Remick SC, Shah MH, Leichman L, Ratner L, Cesarman E, Chadburn A, Mitsuyasu R; AIDS Malignancy Consortium. Rituximab plus concurrent infusional EPOCH chemotherapy is highly effective in HIV-associated B-cell non-Hodgkin lymphoma. Blood. 2010 Apr 15;115(15):3008-16. Epub 2009 Dec 18.

Sparano JA, Lee J, Kaplan LD: Randomized phase II trial of infusional EPOCH chemotherapy given either concurrently with or sequentially followed by rituximab in HIV-associated lymphoma: AIDS Malignancy Consortium 034. [Abstract] 10th International Conference on Malignancies in AIDS and Other Acquired Immunodeficiencies, October 16-17, 2006, Bethesda, MD A-11, 2006.

Other Publications:

Chadburn A, Chen X, Chiu A, et al.: Neither germinal center (GC) vs non-germinal center (Non-GC) phenotype nor FOXP1 expression correlate with outcome in AIDS-associated diffuse large B-cell lymphoma (DLBCL): study of patients from AIDS Malignancies Consortium trials 010 and 034. [Abstract] Blood 108 (11): A-2023, 2006.

Responsible Party:	AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:	NCT00049036 History of Changes
Other Study ID Numbers:	CDR0000257660, U01CA070019, AMC-034, ECOG-AMC34
Study First Received:	November 12, 2002
Results First Received:	May 23, 2011
Last Updated:	November 17, 2011
Health Authority:	United States: Food and Drug Administration