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NCT03515512 · ClinicalTrials.gov registry record · Phase 1
IDH2 Inhibition Using Enasidenib as Maintenance Therapy for IDH2-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation
A Phase 1 study of Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 4
- Study locations
NCT03515512: Completed Phase 1 study of Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, sponsored by Massachusetts General Hospital.
NCT03515512 is a Phase 1 study of Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia that has completed, run by Massachusetts General Hospital. The registered enrollment target is 23 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (80% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03515512, a Phase 1 study of Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 4
- Study locations
Study Summary
This research study is studying a targeted therapy drug as a possible treatment for IDH2 mutant acute myeloid leukemia or chronic myelomonocytic leukemia while undergoing hematopoietic stem cell transplantation. The drug involved in this study is: -Enasidenib.
Primary Outcome
The maximum tolerated dose of Enasidenib in this patient population. The Maximum Tolerated Dose (MTD) is defined as the highest dose level at which 0 or 1 of six patients experiences a dose-limiting toxicity (DLT). MTD is determined using a standard 3 + 3 dose escalation cohort, where 3 participants will be enrolled on the starting dose of 50 mg daily and if no DLT is experienced after a full 28-day cycle, 3 additional participants will be enrolled at the next dose level of 100mg daily. If durin
Conditions Studied
Interventions
- DRUG Enasidenib
Study Locations (4)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
Maryland
- Johns Hopkins Cancer Center - Baltimore
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-07-17 |
| Est. Completion | 2023-02-13 |
| Phase | Phase 1 |
What the finished NCT03515512 record still lists
NCT03515512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Enasidenib is the first listed.
NCT03515512 reports a single indexed study location in Massachusetts, Maryland, Ohio.
Frequently Asked Questions
What is clinical trial NCT03515512 about?
NCT03515512 is a clinical study titled "IDH2 Inhibition Using Enasidenib as Maintenance Therapy for IDH2-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation". This research study is studying a targeted therapy drug as a possible treatment for IDH2 mutant acute myeloid leukemia or chronic myelomonocytic leukemia while undergoing hematopoietic stem cell transplantation. The drug involved in this study is: -Enasidenib.
What is the current status of trial NCT03515512?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2018-07-17. Estimated completion is 2023-02-13.
What conditions does trial NCT03515512 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia.
What interventions are being tested in trial NCT03515512?
The interventions under investigation include: Enasidenib (DRUG).
Who is sponsoring clinical trial NCT03515512?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03515512 being conducted?
This trial has 4 study locations across Maryland, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03515512's enrollment target sits among peer trials
23 233rd of 306 higher than 72 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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