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NCT02196857 · ClinicalTrials.gov registry record · Phase 2
Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MS) With FLT3-ITD Mutation
A Phase 2 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02196857: Completed Phase 2 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT02196857 is a Phase 2 study of Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 16 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02196857, a Phase 2 study of Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can help to control the disease in patients with Acute Myeloid Leukemia (AML) and high risk Myelodisplastic Syndrome (MDS) with FLT3-ITD mutation. The safety of this drug combination will also be studied.
Primary Outcome
Criteria for response per the International Working Group for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Complete Response (CR) was defined as \</= 5% blasts in the bone marrow (BM) with peripheral blood (PB) demonstrating greater thatn 1x10\^9/L platelets with no detectable extramedullary disease. CR with incomplete recovery of PB counts (CRi) is the above criteria but neutrophil or platelet counts less than the stated values. Partial Response (PR) required all of the hema
Conditions Studied
Interventions
- DRUG Sorafenib
- DRUG Azacytidine
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-02-06 |
| Est. Completion | 2018-11-27 |
| Phase | Phase 2 |
What the finished NCT02196857 record still lists
NCT02196857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Sorafenib is the first listed.
NCT02196857 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02196857 about?
NCT02196857 is a clinical study titled "Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MS) With FLT3-ITD Mutation". The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can help to control the disease in patients with Acute Myeloid Leukemia (AML) and high risk Myelodisplastic Syndrome (MDS) with FLT3-ITD mutation. The safety of this drug combination will also be studied.
What is the current status of trial NCT02196857?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2015-02-06. Estimated completion is 2018-11-27.
What conditions does trial NCT02196857 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT02196857?
The interventions under investigation include: Sorafenib (DRUG), Azacytidine (DRUG).
Who is sponsoring clinical trial NCT02196857?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02196857 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 Leukemia
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 NCT02196857's enrollment target sits among peer trials
16 195th of 233 higher than 31 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia 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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A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes
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