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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: Recruiting Phase 1 study of Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, sponsored by Karen Ballen, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Severity is based upon CTCAE v5 criteria.
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 |
What NCT05233618 shows while recruiting
NCT05233618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (62% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05233618's enrollment target sits among peer trials
44 163rd of 306 higher than 142 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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