Phase I/II Study of Tagraxofusp in Combination With Decitabine for Patients With Myelomonocytic/M… (NCT05038592) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Phase I/II Study of Tagraxofusp in Combination With Decitabine for Patients With Myelomonocytic/Myeloproliferative Neoplasm and High Risk Myelodysplastic Syndromes
United States64 participantsStarted 2022-03-04
Plain-language summary
This phase I/II trial studies the side effects, best dose, and effect of tagraxofusp and decitabine in treating patients with chronic myelomonocytic leukemia. Tagraxofusp consists of human interleukin 3 (IL3) linked to a toxic agent called DT388. IL3 attaches to IL3 receptor positive cancer cells in a targeted way and delivers DT388 to kill them. Chemotherapy drugs, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tagraxofusp and decitabine may help to control the disease in patients with chronic myelomonocytic leukemia.
Who can participate
Age range
18 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 participant is ≥ 18 years old
* Diagnosis of myelodysplastic/myeloproliferative neoplasm (MDS/MPN) according to World Health Organization (WHO) and:
* Phase 1 dose escalation portion: CMML-1 or CMML-2 by WHO or higher-risk MDS (defined as IPSS-Revised score \>3.5 or with TP53 mutations) with \>5% blasts or MDS/MPN (other than CMML) with \>5% bone marrow blasts and no response after 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 (decitabine-cedazuridine) or relapse or progression after any number of cycles
* Phase 2 dose expansion portion:
* Relapsed cohort (Cohort A): CMML-1 or CMML-2 or higher-risk MDS (defined as IPSS-Revised score \>3.5 or with TP53 mutations) with \>5% blasts or MDS/MPN (other than CMML) with \>5% bone marrow blasts by WHO and no response after 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 (decitabine-cedazuridine) or relapse or progression after any number of cycles
* Hypomethylating agents (HMA) naive cohort (Cohort B): previously untreated CMML-1 or CMML-2 and intermediate-2 or high-risk IPSS or higher-risk MDS (defined as IPSS-Revised score \>3.5 or with TP53 mutations) with \>5% blasts or MDS/MPN (other than CMML) with \>5% bone marrow blasts.
* The patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
* Left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition scan or 2-dimensional (2-D) echocardiogram (ECHO) within 2…
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
Maximum tolerable dose (Phase I)
Timeframe: At end of cycle 1 (1 cycle = 28 days)
2
Incidence of dose limiting toxicities (Phase I)
Timeframe: Up to end of cycle 1 (1 cycle = 28 days)
3
Overall response (OR) (Phase II)
Timeframe: After 2 cycles of therapy (1 cycle = 28 days)