Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MDS, MF and CMML (HSCT 002)

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Karen Ballen, MD
Study ID
NCT05233618
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tagraxofusp — DRUG
    inpatient on days 1-3 of cycles 1-4 and days 1-2 of additional cycles

Study Details

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.

Key Dates

Start date
Jul 13, 2022
Status verified
May 2025
Primary completion
Jul 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tagraxofusp (escalating doses)
    IV tagraxofusp on days 1-3 of cycles 1-4 and days 1-2 of additional cycles for up to 9 cycles (some participants could receive more if considered in their best interest)

Primary Outcome Measure

Incidence and severity of grade ≥ 3 adverse events [ Time Frame: Through about 30 days following last infusion of tagraxofusp ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Samantha Matusiak
[email protected]
Margaret Kasner, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22901
Samantha Brooks
[email protected]
4345541718
Karen Ballen, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
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By specialty
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By research site
Thomas Jefferson University· Philadelphia, PAUniversity of Virginia· Charlottesville, VA

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