Phase I Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myelofibrosis and Chronic Myelomonocytic Leukemia

Who is this study for? Patients with CD 123+ acute myeloid leukemia, myelofibrosis and chronic myelomonocytic leukemia
What treatments are being studied? Tagraxofusp
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• The patient is ≥18 years old and ≤ 75 years old.

• The patient has a life expectancy of \>6 months.

• The patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.

• The patient has adequate baseline organ function, including cardiac, renal, and hepatic function within 28 days of start of therapy:

‣ Left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition scan (MUGA) or 2-dimensional (2-D) echocardiogram (ECHO) and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG)

⁃ Serum Creatinine ≤ 1.5 mg/dL

⁃ Bilirubin ≤1.5 mg/dL

⁃ Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN)

⁃ Absolute neutrophil count (ANC) ≥0.5 × 10⁹/L

⁃ Platelets ≥ 80,000/mm\^3

⁃ Serum albumin ≥3.2 (note that albumin infusions are not permitted in order to enable eligibility)

• Patient meets the 2016 WHO diagnostic criteria for MF, is CD 123+, and has an IPSS/DIPSS/DIPSS-plus intermediate-1 with anemia (Hb \< 10g/dl), splenomegaly (\> 12 cm), leukocytosis (WBC \> 25K) intermediate-2 or high-risk disease pre transplant.

• Or

• Patient has a 2016 WHO-defined diagnosis of CMML (persistent monocytosis ≥1 × 10⁹/L for at least 3 months, with other causes excluded, and monocytes ≥10% of WBC in peripheral blood, no criteria and no previous history of CML, ET, PV, and acute promyelocytic leukemia) pre transplant and is CD123+

• Or

• Patient has 2016 WHO-defined CMML-1 (2-4% blasts in peripheral blood and/or 5-9% blasts in bone marrow) and CMML-2 (5-19% blasts in peripheral blood and/or 10-19% blasts in bone marrow, and/or presence of Auer rods) pre transplant and is CD 123+

• Or

• Patient has CD 123+ AML in morphologic remission pre transplant

• Or

• Patient has Intermediate or high risk MDS by IPSS-R or moderate or high risk by IPSS-M pre transplant and has had no morphologic progression of disease post-transplant.

• Receipt of first allogeneic stem cell transplant (related, unrelated, haploidentical or cord blood) 60-120 days prior to study registration

• Patient is in morphologic remission according to bone marrow biopsy completed within 30 days prior to planned start of study treatment

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• For females and males of reproductive potential: agreement to use adequate contraception for at least one month prior to screening, during study participation and for an additional one week after the end of study drug administration. Other (non-study) medications may require participants to use adequate contraception for longer.

⁃ For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Other (non-study) medications may require participants to use adequate contraception for longer.

⁃ Agreement to adhere to Lifestyle Considerations throughout study duration

Locations
United States
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Samantha Brooks
SNB3GC@uvahealth.org
4349823365
Time Frame
Start Date: 2022-07-13
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 44
Treatments
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)
Sponsors
Leads: Karen Ballen, MD

This content was sourced from clinicaltrials.gov

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