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NCT01421173 · ClinicalTrials.gov registry record · Phase 1
Vorinostat With Gemcitabine, Busulfan, and Melphalan With Stem Cell Transplant (SCT) in Relapsed or Refractory Lymphoid Malignancies
A Phase 1 study of Lymphoma, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT01421173: Completed Phase 1 study of Lymphoma, sponsored by M.D. Anderson Cancer Center.
NCT01421173 is a Phase 1 study of Lymphoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 78 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421173, a Phase 1 study of Lymphoma, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of vorinostat that can be given with gemcitabine, busulfan, and melphalan with a stem cell transplant. Researchers also want to learn about the safety and level of effectiveness of this combination. Busulfan and melphalan are designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may help to increase the effect of busulfan and melphalan on cancer cells by not allowing these cells to repair the DNA damage caused by busulfan or melphalan. Vorinostat is designed to open up the DNA and allow greater access to drugs that bind to DNA, such as gemcitabine, busulfan and melphalan.
Primary Outcome
No more than 2 patients enrolled at one time in new dose level, until toxicities of at least 1 of those are assessed \& determined not to be DLT, no more patients enrolled at new dose level. Dose escalation of vorinostat starts at level 1a (200 mg/day) and Gemcitabine (2175 mg/m2/day). If level tolerable, dose proceeds from level 2a (300 mg) to level 11a (1000 mg) at increase of 100 mg per level. If level 1a were not tolerable, i.e., greater than 20% DLTs (determined by Continual Reassessment Me
Conditions Studied
Interventions
- DRUG Melphalan
- DRUG Busulfan
- DRUG Gemcitabine
- DRUG Vorinostat
- PROCEDURE Stem Cell Infusion
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT01421173 record still lists
NCT01421173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Melphalan is the first listed.
NCT01421173 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01421173 about?
NCT01421173 is a clinical study titled "Vorinostat With Gemcitabine, Busulfan, and Melphalan With Stem Cell Transplant (SCT) in Relapsed or Refractory Lymphoid Malignancies". The goal of this clinical research study is to find the highest tolerable dose of vorinostat that can be given with gemcitabine, busulfan, and melphalan with a stem cell transplant. Researchers also want to learn about the safety and level of effectiveness of this combination. Busulfan and melphala...
What is the current status of trial NCT01421173?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2011-08. Estimated completion is 2015-09.
What conditions does trial NCT01421173 study?
This clinical trial studies the following conditions: Lymphoma.
What interventions are being tested in trial NCT01421173?
The interventions under investigation include: Melphalan (DRUG), Busulfan (DRUG), Gemcitabine (DRUG), Vorinostat (DRUG), Stem Cell Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT01421173?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01421173 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01421173's enrollment target sits among peer trials
78 106th of 299 higher than 191 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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.
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