Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MDS, MF and CMML (HSCT 002)
NCT05233618 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2025-05-28
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
- Myelofibrosis
- Chronic Myelomonocytic Leukemia
- Acute Myeloid Leukemia
Interventions
- DRUG
-
Tagraxofusp
inpatient on days 1-3 of cycles 1-4 and days 1-2 of additional cycles
Sponsors & Collaborators
-
Karen Ballen, MD
lead OTHER
Principal Investigators
-
Karen Ballen · UVA
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-13
- Primary Completion
- 2026-07-01
- Completion
- 2026-10-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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