CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
Cyclophosphamide +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01193842
NCT01193842Phase 2Completed

A Sequential Phase I/Randomized Phase II Trial of Vorinostat and Risk-Adapted Chemotherapy With Rituximab in HIV-Related B-Cell Non-Hodgkin's Lymphoma

National Cancer Institute (NCI)·interventional·Posted Sep 2, 2010·Updated Nov 21, 2023

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Doxorubicin Hydrochloride, and 7 other interventions for AIDS-Related Plasmablastic Lymphoma and 15 related conditions. Completed, enrolled 107 participants across 35 sites.

Detailed Summary

This partially randomized phase I/II trial studies the side effects and the best dose of vorinostat when given together with combination chemotherapy and rituximab to see how well it works compared to combination chemotherapy alone in treating patients with human immunodeficiency virus-related diffuse large B-cell non-Hodgkin lymphoma or other aggressive B-cell lymphomas. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving vorinostat together with combination chemotherapy and rituximab may kill more cancer cells.

Study Details

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2010
Enrollment StartOct 6, 2010
Primary CompletionNov 12, 2016
Study CompletionMay 19, 2022
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 15.8 years ago

Interventions

Cyclophosphamidedrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Prednisonedrug

Given PO

Rituximabbiological

Given IV

Vincristine Sulfatedrug

Given IV

Vorinostatdrug

Given PO