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NCT01983969 · ClinicalTrials.gov registry record · Phase 1
Aza-SAHA-GBM With AutoSCT for Refractory Lymphoma
A Phase 1 study of Lymphoma and Advanced Cancers, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT01983969: Completed Phase 1 study of Lymphoma and Advanced Cancers, sponsored by M.D. Anderson Cancer Center.
NCT01983969 is a Phase 1 study of Lymphoma and Advanced Cancers that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 61 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01983969, a Phase 1 study of Lymphoma and Advanced Cancers, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of azacitidine that can be given with vorinostat, gemcitabine, busulfan, and melphalan, with a stem cell transplant, and with or without rituximab. Researchers also want to learn about the safety and level of effectiveness of this combination.
Primary Outcome
Maximum tolerated dose (MTD) of azacitidine based on DLT was defined as any Grade 4 nonhematologic and noninfectious toxicity or any grade 3 mucositis or skin toxicity lasting \> 3 days at peak severity. For dose finding, the continunal reassessment method was used with a target DLT probability per cohort of 25%. Azacitidine doses were chosen adaptively for sucessive cohorts with a minimum size of 2 patients. Toxicity scoring followed the National Cancer Institute Common Toxicity Criteria, versi
Conditions Studied
Interventions
- DRUG Melphalan
- DRUG Busulfan
- DRUG Azacitidine
- DRUG Gemcitabine
- DRUG Vorinostat
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2013-11-07 |
| Est. Completion | 2017-11-22 |
| Phase | Phase 1 |
What the finished NCT01983969 record still lists
NCT01983969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Melphalan is the first listed.
NCT01983969 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01983969 about?
NCT01983969 is a clinical study titled "Aza-SAHA-GBM With AutoSCT for Refractory Lymphoma". The goal of this clinical research study is to find the highest tolerable dose of azacitidine that can be given with vorinostat, gemcitabine, busulfan, and melphalan, with a stem cell transplant, and with or without rituximab. Researchers also want to learn about the safety and level of effectivenes...
What is the current status of trial NCT01983969?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2013-11-07. Estimated completion is 2017-11-22.
What conditions does trial NCT01983969 study?
This clinical trial studies the following conditions: Lymphoma, Advanced Cancers.
What interventions are being tested in trial NCT01983969?
The interventions under investigation include: Melphalan (DRUG), Busulfan (DRUG), Azacitidine (DRUG), Gemcitabine (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT01983969?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01983969 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
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Where NCT01983969's enrollment target sits among peer trials
61 126th of 299 higher than 172 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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