RECRUITING

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

Conditions

Myelofibrosis Chronic Myelomonocytic Leukemia Acute Myeloid Leukemia Hematopoietic Stem Cell Transplant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-13

Study Completion:2026-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05233618

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. The patient is ≥18 years old and ≤ 75 years old. 2. The patient has a life expectancy of \>6 months. 3. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. 4. 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) 5. 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. 6. Receipt of first allogeneic stem cell transplant (related, unrelated, haploidentical or cord blood) 60-120 days prior to study registration 7. Patient is in morphologic remission post-HCT and at the time of study registration 8. Provision of signed and dated informed consent form 9. Stated willingness to comply with all study procedures and availability for the duration of the study 10. 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. 11. 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. 12. Agreement to adhere to Lifestyle Considerations throughout study duration	1. Treatment with any disease-related therapy, including radiation therapy or investigational agent, within 14 days of study entry 2. Previous treatment with tagraxofusp or known hypersensitivity to any components of the drug product 3. Active malignancy and/or cancer history (excluding myeloproliferative disorders and concomitant myeloid malignancies as specified in the inclusion criteria) that can confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of entry) and/or ongoing active malignancy or substantial potential for recurrence must be discussed with the Sponsor before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of progressive disease. 4. Known active or suspected disease involvement of the central nervous system (CNS) 5. Receiving \> 10 mg prednisone daily for GVHD 6. Overall Grade 2 or greater acute GVHD (per Magic criteria) at time of registration 7. Pregnant or breast feeding 8. Requirement of supplemental oxygen 9. Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within 6 months of study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication) 10. Uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study 11. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements 12. Known positive status for human immunodeficiency virus or active or chronic Hepatitis B or Hepatitis C 13. Receiving treatment for known or suspected fungal infection (prophylaxis is acceptable) 14. Known positive SARS-COV-2 test within 3 weeks of study entry. Exception: Tests that reflect past, resolved infection where the patient is determined to NOT be infectious, according to an infectious disease specialist, do not exclude the patient from participation. 15. Pedal edema ≥ grade 2

Inclusion Criteria

Exclusion Criteria

1. The patient is ≥18 years old and ≤ 75 years old.
2. The patient has a life expectancy of \>6 months.
3. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
4. 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)
5. 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.
6. Receipt of first allogeneic stem cell transplant (related, unrelated, haploidentical or cord blood) 60-120 days prior to study registration
7. Patient is in morphologic remission post-HCT and at the time of study registration
8. Provision of signed and dated informed consent form
9. Stated willingness to comply with all study procedures and availability for the duration of the study
10. 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.
11. 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.
12. Agreement to adhere to Lifestyle Considerations throughout study duration

1. Treatment with any disease-related therapy, including radiation therapy or investigational agent, within 14 days of study entry
2. Previous treatment with tagraxofusp or known hypersensitivity to any components of the drug product
3. Active malignancy and/or cancer history (excluding myeloproliferative disorders and concomitant myeloid malignancies as specified in the inclusion criteria) that can confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of entry) and/or ongoing active malignancy or substantial potential for recurrence must be discussed with the Sponsor before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of progressive disease.
4. Known active or suspected disease involvement of the central nervous system (CNS)
5. Receiving \> 10 mg prednisone daily for GVHD
6. Overall Grade 2 or greater acute GVHD (per Magic criteria) at time of registration
7. Pregnant or breast feeding
8. Requirement of supplemental oxygen
9. Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within 6 months of study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication)
10. Uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study
11. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements
12. Known positive status for human immunodeficiency virus or active or chronic Hepatitis B or Hepatitis C
13. Receiving treatment for known or suspected fungal infection (prophylaxis is acceptable)
14. Known positive SARS-COV-2 test within 3 weeks of study entry. Exception: Tests that reflect past, resolved infection where the patient is determined to NOT be infectious, according to an infectious disease specialist, do not exclude the patient from participation.
15. Pedal edema ≥ grade 2

Contacts and Locations

Study Contact

Danyelle Coley

CONTACT

14349825027

JCS6RZ@uvahealth.org

Samantha Brooks

CONTACT

4349823365

SNB3GC@uvahealth.org

Principal Investigator

Karen Ballen

PRINCIPAL_INVESTIGATOR

UVA

Study Locations (Sites)

Danyelle Coley

Charlottesville, Virginia, 22901

United States

Collaborators and Investigators

Sponsor: Karen Ballen, MD

Karen Ballen, PRINCIPAL_INVESTIGATOR, UVA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-13

Study Completion Date2026-10-01

Study Record Updates

Study Start Date2022-07-13

Study Completion Date2026-10-01

Terms related to this study

Keywords Provided by Researchers

Hematopoietic Stem Cell Transplant

Additional Relevant MeSH Terms

Myelofibrosis
Chronic Myelomonocytic Leukemia
Acute Myeloid Leukemia