Trial · NCT00392834

Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma

NCT00392834, Phase 2, Completed, AIDS Malignancy Consortium; results first posted 2013-02-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma. Trials, record NCT00392834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00392834

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma
NCT number: NCT00392834
Status: Completed
Phases: Phase 2
Enrollment: 34 participants, actual
Lead sponsor: AIDS Malignancy Consortium
Conditions: Lymphoma
Interventions: filgrastim, pegfilgrastim, rituximab, cyclophosphamide, cytarabine, doxorubicin hydrochloride, etoposide, ifosfamide, leucovorin calcium, liposomal cytarabine, methotrexate, therapeutic hydrocortisone, vincristine sulfate
First posted: 2006-10-26
Last updated: 2018-06-06
Results first posted: 2013-02-28

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Overall Survival (OS) at 1 Year	1 year post treatment
Secondary	Complete Response Rate	6-8 weeks post treatment, every 4 months post-treatment for 2 years
Secondary	Failure-free Survival (FFS)	6-8 weeks post treatment, every 4 months post-treatment for 2 years
Secondary	Event-free Survival (EFS)	6-8 weeks post treatment, every 4 months post-treatment for 2 years
Secondary	Toxicity	baseline through 2 years post-treatment
Secondary	Incidence of Infection-related Deaths	baseline through 2 years post-treatment
Secondary	Correlation of C-flip Expression, p53 Mutations, and Multidrug Resistance Expression With OS, FFS, and EFS	baseline through 2 years post-treatment
Secondary	Utility of Flow Cytometry in Detecting Leptomeningeal Disease	baseline and 6-8 weeks post-treatment
Secondary	Degree of Disconcordance Between Flow Cytometry and CNS Cytology Results	baseline
Secondary	Biologic and Prognostic Significance of Epstein-Barr Virus (EBV) at Diagnosis and Correlation With OS, FFS, and EFS	baseline through 2 years post-treatment

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Overall Survival (OS) at 1 Year	1 year post treatment	Cumulative proportion surviving at 1 yr	NUMBER
SECONDARY	Complete Response Rate	6-8 weeks post treatment, every 4 months post-treatment for 2 years
SECONDARY	Failure-free Survival (FFS)	6-8 weeks post treatment, every 4 months post-treatment for 2 years
SECONDARY	Event-free Survival (EFS)	6-8 weeks post treatment, every 4 months post-treatment for 2 years
SECONDARY	Toxicity	baseline through 2 years post-treatment
SECONDARY	Incidence of Infection-related Deaths	baseline through 2 years post-treatment
SECONDARY	Correlation of C-flip Expression, p53 Mutations, and Multidrug Resistance Expression With OS, FFS, and EFS	baseline through 2 years post-treatment
SECONDARY	Utility of Flow Cytometry in Detecting Leptomeningeal Disease	baseline and 6-8 weeks post-treatment
SECONDARY	Degree of Disconcordance Between Flow Cytometry and CNS Cytology Results	baseline
SECONDARY	Biologic and Prognostic Significance of Epstein-Barr Virus (EBV) at Diagnosis and Correlation With OS, FFS, and EFS	baseline through 2 years post-treatment

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival (OS) at 1 Year	Regimen A (R-CODOX-M Chemotherapy)		1.0	95% Confidence Interval 1.0 to 1.0	Cumulative proportion surviving at 1 yr
Overall Survival (OS) at 1 Year	Regimen B (Rituximab and IVAC Chemotherapy)		0.82	95% Confidence Interval 0.62 to 0.92	Cumulative proportion surviving at 1 yr

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Regimen A (R-CODOX-M Chemotherapy)	2
Overall Study	STARTED	Regimen B (Rituximab and IVAC Chemotherapy)	32
Overall Study	COMPLETED	Regimen A (R-CODOX-M Chemotherapy)	2
Overall Study	COMPLETED	Regimen B (Rituximab and IVAC Chemotherapy)	32
Overall Study	NOT COMPLETED	Regimen A (R-CODOX-M Chemotherapy)	0
Overall Study	NOT COMPLETED	Regimen B (Rituximab and IVAC Chemotherapy)	0

Source ClinicalTrials.gov

Adverse events128

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Regimen A (R-CODOX-M Chemotherapy)	0	2	0
other	Anemia	Blood and lymphatic system disorders	Regimen B (Rituximab and IVAC Chemotherapy)	15	32	34
other	Febrile neutropenia	Blood and lymphatic system disorders	Regimen A (R-CODOX-M Chemotherapy)	0	2	0
other	Febrile neutropenia	Blood and lymphatic system disorders	Regimen B (Rituximab and IVAC Chemotherapy)	3	32	4
other	Diarrhea	Gastrointestinal disorders	Regimen A (R-CODOX-M Chemotherapy)	0	2	0
other	Diarrhea	Gastrointestinal disorders	Regimen B (Rituximab and IVAC Chemotherapy)	2	32	3
other	Oral mucositis	Gastrointestinal disorders	Regimen A (R-CODOX-M Chemotherapy)	0	2	0
other	Oral mucositis	Gastrointestinal disorders	Regimen B (Rituximab and IVAC Chemotherapy)	2	32	2
other	Nausea	Gastrointestinal disorders	Regimen A (R-CODOX-M Chemotherapy)	0	2	0
other	Nausea	Gastrointestinal disorders	Regimen B (Rituximab and IVAC Chemotherapy)	4	32	4

1 to 10 of 128Source ClinicalTrials.gov

See all 128 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regimen A (R-CODOX-M Chemotherapy)
Total, all-cause mortality	Regimen B (Rituximab and IVAC Chemotherapy)
Total, other adverse events	Regimen A (R-CODOX-M Chemotherapy)	0	2
Total, other adverse events	Regimen B (Rituximab and IVAC Chemotherapy)	22	32
Total, serious adverse events	Regimen A (R-CODOX-M Chemotherapy)	0	2
Total, serious adverse events	Regimen B (Rituximab and IVAC Chemotherapy)	23	32

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25957391	RESULT

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01CA070019	AMC OPERATIONS CENTER	LEE, JEANNETTE Y.	UNIVERSITY OF ALABAMA AT BIRMINGHAM	NATIONAL CANCER INSTITUTE	1995 to 2005

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Regimen A (R-CODOX-M Chemotherapy) vs Regimen B (Rituximab and IVAC Chemotherapy): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00392834

GET https://conductscience.org/api/trials/v1/NCT00392834/events?page=2

API reference For AI assistants