First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, A… (NCT03594955) | Clinical Trial Compass
TerminatedPhase 1/2
First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome
Stopped: Sponsor decision
United States, France7 participantsStarted 2018-10-24
Plain-language summary
Primary Objective:
* Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in participants with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic syndrome (HR-MDS), or B-cell acute lymphoblastic leukemia (B-ALL), and determine the recommended phase 2 dose (RP2D) for the subsequent Expansion part.
* Expansion part: To assess the activity of single agent SAR440234 at the RP2D in participants with R/R AML or HR-MDS.
Secondary Objective:
* To characterize the safety profile including cumulative adverse drug reactions.
* To evaluate the potential immunogenicity of SAR440234.
* To assess any preliminary evidence of hematologic response in the Dose Escalation Part.
Who can participate
Age range
16 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:
* Confirmed diagnosis of Acute Myeloblastic leukemia (AML) (except acute promyelocytic leukemia), or myelodysplastic syndrome (MDS) with a risk category of intermediate or higher. Participants must had exhausted available treatment options and might not be eligible for any treatment known to provide clinical benefit.
* Participants with AML must had relapsed or refractory disease that had been resistant to available therapies.
* Participants with B-ALL (B acute lymphoid leukemia) in second or subsequent relapse: should had completed previously greater than or equal to (\>=) 1 cycle of a salvage regimen. Participants must had exhausted available treatment options and must not be eligible for any treatment known to provide clinical benefit.
* Participants with HR-MDS (high risk myelodysplastic syndrome) must have greater than (\>) 10 percentage blasts in the bone marrow at the time of enrollment and fit one of the following categories: Not eligible for induction therapy and having completed \>=2 cycles of therapy or not eligible for allogeneic stem cell transplant and had completed \>=1 course of induction therapy.
* Signed written informed consent.
Exclusion criteria:
* Aged less than 16 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status \>2.
* Participants with inadequate biological tests.
* White blood cell count \> 30,000 per cubic millimeter.
* History of active or chronic autoimmune conditions that had required or requires the…
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 Escalation Part: Number of Participants With Dose Limiting Toxicities (DLTs)
Timeframe: Cycle 1 (42 days)
2
Dose Escalation Part: Number of Participants With Allergic Reactions/Hypersensitivity and Cytokine Release Syndrome/Acute Infusion Reactions
Timeframe: First IMP administration (Day 1) up to last dose of IMP + 30 days (i.e., up to 72 days)
3
Expansion Part: Percentage of Participants With Overall Response (OR) Per International Working Group (IWG) Criteria
Timeframe: From the date of first IMP administration until disease progression or death, whichever came earlier (up to 42 days)
4
Expansion Part: Duration of Response (DOR)
Timeframe: From 1st documentation of response to date of first documentation of disease progression or death, whichever came earlier (up to 42 days)
5
Expansion Part: Number of Participants With Disease-free Survival
Timeframe: First IMP administration to date of first documentation of disease progression or relapse or death, whichever came earlier (up to 42 days)