Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia (NCT04742101) | Clinical Trial Compass
CompletedPhase 1/2
Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia
France, Hungary, Poland57 participantsStarted 2021-03-10
Plain-language summary
The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S65487 with azacitidine in patients with acute myeloid leukaemia.
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:
* Male or female participant aged ≥ 18 years old
* Participants with cytologically confirmed and documented treatment naïve, de novo or secondary AML defined by WHO 2016 classification (Arber, 2016). Secondary AML includes:
* Previous myelodysplastic syndrome transformed
* AML due to exposure to potentially leukemogenic therapies or agents (e.g. radiation therapy, alkylating agents, topoisomerase II inhibitors) with the primary malignancy in remission for at least 3 years
* Participants not eligible for standard induction chemotherapy
* Aged ≥ 75 years old
* Or Age ≥18 years with at least one of the following comorbidities:
* Clinically significant heart or lung comorbidities, as reflected by at least one of:
* Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected
* Forced expiratory volume in 1 second (FEV1) ≤65% of expected
* Other contraindication(s) to anthracycline therapy (must be documented)
* Other comorbidity that the Investigator judges as incompatible with intensive remission induction chemotherapy, which must be documented
* ECOG (Eastern Cooperative Oncology Group) performance status should be (criterion should be rechecked at inclusion visit) ECOG ≤ 2.
* Written informed consent obtained prior any study-specific procedure as described in section 13.3 of the protocol.
* Adequate renal and hepatic function
* Circulating White Blood Cell Count (WBC count) \< 25\*109 G/L (with or without use of h…
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
Dose Limiting Toxicity (DLT) (phase I part)
Timeframe: Through the end of first cycle (each cycle is 28 days)
2
Adverse Event (phase I part)
Timeframe: Through study completion, an average of 3 years ans 5 months
3
Complete Remission (CR) rate (phase II part)
Timeframe: Through study completion, up to 3 years and 5 months
Trial details
NCT IDNCT04742101
SponsorInstitut de Recherches Internationales Servier