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NCT07320235 · ClinicalTrials.gov registry record · Phase 1
Imetelstat Combinations in Relapsed AML
A Phase 1 study of Relapsed Acute Myeloid Leukemia, sponsored by Douglas Tremblay.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT07320235 is a Phase 1 study of Relapsed Acute Myeloid Leukemia that is actively recruiting participants, run by Douglas Tremblay. The registered enrollment target is 36 participants, below the 53-participant average among 5 other Relapsed Acute Myeloid Leukemia trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07320235, a Phase 1 study of Relapsed Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Douglas Tremblay.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
IMAGINE is a two-part trial to evaluate the safety and preliminary efficacy of imetelstat in combination with azacitidine with or without venetoclax in patients with relapsed or refractory AML. The trial will consist of a safety run-in phase (Part A) employing a 3+3 design to monitor dose-limiting toxicities of imetelstat when administered in combination with a fixed dose of azacitidine. Part B will consist of a phase 1b trial employing a BOIN12 design to determine the optimal biological dose of imetelstat, starting at a lower dose level, in combination with azacitidine and venetoclax. Total of up to 36 participants will be accrued over 54 months at Mount Sinai Hospital. Estimated duration of trial is 114 months including recruitment, screening, treatment, and follow-up.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Imetelstat
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2026-01 |
| Est. Completion | 2035-06-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07320235
The ClinicalTrials.gov registry entry for NCT07320235 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 53-participant average among 5 other Relapsed Acute Myeloid Leukemia trials with a reported enrollment target (32% lower). The listed sponsor is Douglas Tremblay, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Relapsed Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT07320235 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT07320235 about?
NCT07320235 is a clinical study titled "Imetelstat Combinations in Relapsed AML". IMAGINE is a two-part trial to evaluate the safety and preliminary efficacy of imetelstat in combination with azacitidine with or without venetoclax in patients with relapsed or refractory AML. The trial will consist of a safety run-in phase (Part A) employing a 3+3 design to monitor dose-limiting t...
What is the current status of trial NCT07320235?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2026-01. Estimated completion is 2035-06-15.
What conditions does trial NCT07320235 study?
This clinical trial studies the following conditions: Relapsed Acute Myeloid Leukemia.
What interventions are being tested in trial NCT07320235?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Imetelstat (DRUG).
Who is sponsoring clinical trial NCT07320235?
This trial is sponsored by Douglas Tremblay, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07320235 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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