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NCT05233618 · ClinicalTrials.gov registry record · Phase 1
Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MDS, MF and CMML (HSCT 002)
A Phase 1 study of Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, sponsored by Karen Ballen, MD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 2
- Study locations
NCT05233618 is a Phase 1 study of Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia that is actively recruiting participants, run by Karen Ballen, MD. The registered enrollment target is 44 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (62% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05233618, a Phase 1 study of Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, is actively recruiting participants, sponsored by Karen Ballen, MD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 2
- Study locations
Study Summary
In this study, tagraxofusp (Tag) is given to patients with CD 123+ myelofibrosis (MF), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML) after allogeneic stem cell transplant (HCT) to help prevent relapse. Patients will receive up to about 9 cycles of treatment with Tag and have a bone marrow biopsy after cycle 4 and about 1 year after HCT.
Conditions Studied
Interventions
- DRUG Tagraxofusp
Study Locations (2)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2026-10-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05233618
The ClinicalTrials.gov registry entry for NCT05233618 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (62% lower). The listed sponsor is Karen Ballen, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Tagraxofusp is the first listed.
NCT05233618 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Pennsylvania, Virginia.
Frequently Asked Questions
What is clinical trial NCT05233618 about?
NCT05233618 is a clinical study titled "Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MDS, MF and CMML (HSCT 002)". In this study, tagraxofusp (Tag) is given to patients with CD 123+ myelofibrosis (MF), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML) after allogeneic stem cell transplant (HCT) to help prevent relapse. Patients will receive up to about 9 cycles of treatment with Tag and ha...
What is the current status of trial NCT05233618?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2022-07-13. Estimated completion is 2026-10-01.
What conditions does trial NCT05233618 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelofibrosis.
What interventions are being tested in trial NCT05233618?
The interventions under investigation include: Tagraxofusp (DRUG).
Who is sponsoring clinical trial NCT05233618?
This trial is sponsored by Karen Ballen, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05233618 being conducted?
This trial has 2 study locations across Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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