Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MDS, MF and C… (NCT05233618) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MDS, MF and CMML (HSCT 002)
United States44 participantsStarted 2022-07-13
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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.
. Patient is in morphologic remission according to bone marrow biopsy completed within 30 days prior to planned start of study treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of grade ≥ 3 adverse events
Timeframe: Through about 30 days following last infusion of tagraxofusp
2
Dose limiting toxicities
Timeframe: During cycles 1 and 2 (each cycle is 28 days) of study treatment for each participant
3
Percent of planned tagraxofusp dose received
Timeframe: Through cycle 4 (each cycle is 28 days) of study treatment for each participant
. Provision of signed and dated informed consent form
. Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria
. Treatment with any disease-related therapy, including radiation therapy or investigational agent, within 14 days of study entry
. Previous treatment with tagraxofusp or known hypersensitivity to any components of the drug product
. 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.
. Known active or suspected disease involvement of the central nervous system (CNS)
. Receiving \> 10 mg prednisone daily for GVHD
. Overall Grade 2 or greater acute GVHD (per Magic criteria) at time of registration