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NCT01193842 · ClinicalTrials.gov registry record · Phase 1
Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
NCT01193842: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01193842 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 107 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01193842, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
Study 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.
Primary Outcome
Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study a
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Doxorubicin Hydrochloride
- DRUG Etoposide
- OTHER Pharmacological Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2010-10-06 |
| Est. Completion | 2022-05-19 |
| Phase | Phase 1 |
What the finished NCT01193842 record still lists
NCT01193842 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01193842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01193842 about?
NCT01193842 is a clinical study titled "Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas". 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 diffu...
What is the current status of trial NCT01193842?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2010-10-06. Estimated completion is 2022-05-19.
What interventions are being tested in trial NCT01193842?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Doxorubicin Hydrochloride (DRUG), Etoposide (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT01193842?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01193842's enrollment target sits among peer trials
107 531st of 2000 higher than 1,470 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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