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NCT02323607 · ClinicalTrials.gov registry record · Phase 1
Pacritinib and Chemotherapy in Treating Patients With Acute Myeloid Leukemia and FLT3 Mutations
A Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia, sponsored by Bhavana Bhatnagar.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT02323607: Completed Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia, sponsored by Bhavana Bhatnagar.
NCT02323607 is a Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia that has completed, run by Bhavana Bhatnagar. The registered enrollment target is 13 participants, below the 54-participant average among 19 other Recurrent Adult Acute Myeloid Leukemia trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02323607, a Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia, has completed, sponsored by Bhavana Bhatnagar.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of pacritinib when given together with chemotherapy in treating patients with acute myeloid leukemia that have an abnormal change (mutation) in the fms-related tyrosine kinase 3 (FLT3) gene. Pacritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, and decitabine, 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. Giving pacritinib and chemotherapy may be a better treatment for acute myeloid leukemia with FLT3 mutations.
Primary Outcome
Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. Toxicities will be tabulated by type and grade and displayed in summary form. Further, all adverse event data that are graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment will be reviewed for completeness.
Conditions Studied
Interventions
- DRUG Decitabine
- OTHER Laboratory Biomarker Analysis
- DRUG Cytarabine
- DRUG Pacritinib
- DRUG Daunorubicin Hydrochloride
Study Locations (1)
Ohio
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2016-01-12 |
| Est. Completion | 2018-07-12 |
| Phase | Phase 1 |
What the finished NCT02323607 record still lists
NCT02323607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 54-participant average among 19 other Recurrent Adult Acute Myeloid Leukemia trials with a reported enrollment target (76% lower).
The record links to 4 conditions, with Recurrent Adult Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Decitabine is the first listed.
NCT02323607 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02323607 about?
NCT02323607 is a clinical study titled "Pacritinib and Chemotherapy in Treating Patients With Acute Myeloid Leukemia and FLT3 Mutations". This phase I trial studies the side effects and best dose of pacritinib when given together with chemotherapy in treating patients with acute myeloid leukemia that have an abnormal change (mutation) in the fms-related tyrosine kinase 3 (FLT3) gene. Pacritinib may stop the growth of cancer cells by b...
What is the current status of trial NCT02323607?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2016-01-12. Estimated completion is 2018-07-12.
What conditions does trial NCT02323607 study?
This clinical trial studies the following conditions: Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia.
What interventions are being tested in trial NCT02323607?
The interventions under investigation include: Decitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Pacritinib (DRUG), Daunorubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02323607?
This trial is sponsored by Bhavana Bhatnagar, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02323607 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02323607's enrollment target sits among peer trials
13 18th of 19 higher than 2 of 19 other Recurrent Adult Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Adult Acute Myeloid 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.
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