CompletedPhase 2

BST-236 as a Single Agent in Adults With Relapsed or Refractory AML or HR-MDS

France38 participantsStarted 2021-05-01

Plain-language summary

To assess the efficacy, and safety of BST-236 in patients unfit for intensive chemotherapy with AML or HR MDS that failed or relapsed following first line therapy

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

. Documented diagnosis of MDS, according to World Health Organization (WHO) classification (Appendix 1) and assessed as higher risk MDS, prior to first line hypomethylating agents (HMA) treatment, according to the Revised International Prognostic Scoring System (IPSS-R) (IPSS-R overall score ≥ 4.5) Or Diagnosed AML according to the 2016 revision to the WHO classification of myeloid neoplasms and acute leukemia: ≥20% blasts in peripheral blood or bone marrow
. Adult ≥18 years of age
. Failure/relapse following prior first-line AML or MDS treatment, defined as:
. For MDS:
. For AML:
. The participant is not able to receive an allogeneic bone marrow transplantation (BMT) at the time of study enrolment (BMT may be an option once the patient completed the study).
. Not eligible for intensive chemotherapy;
. Age ≥75 years Or

Exclusion criteria

. MDS or AML evolving from a pre-existing myeloproliferative neoplasm (MPN)
. MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN

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

Overall hematological response

Timeframe: 2 months

Trial details

NCT IDNCT04827719

SponsorGroupe Francophone des Myelodysplasies

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-13

View on ClinicalTrials.gov More Myelodysplastic Syndromes trials