MCLA-117 in Acute Myelogenous Leukemia (NCT03038230) | Clinical Trial Compass
TerminatedPhase 1
MCLA-117 in Acute Myelogenous Leukemia
Stopped: strategic considerations
United States, Belgium, France80 participantsStarted 2016-04
Plain-language summary
This is a First-in-Human, single arm, open-label, multi-national study designed to determine the safety, tolerability and preliminary efficacy of MCLA 117.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female age ≥18 years old;
✓. Signed informed consent form
✓. One of the two following:
✓. are in relapse to standard therapy following an initial response
✓. failed primary induction therapy with no CR (failed ≥2 courses of intensive induction therapy. Intensive chemotherapy defined as an intensity of ≥ 5+2)
✓. newly diagnosed untreated AML in patients ≥ 65 years of age with high risk cytogenetics, if they are not candidates for standard available induction chemotherapy
✓. AML secondary to MDS, either relapsed or refractory, previously treated with hypomethylating agents for at least 4 cycles;
✓. Relapsed or refractory AML unfit for intensive chemotherapy previously treated with a low intensity regimen (e.g. low dose Ara-c, hypomethylating agent, etc.) including Venetoclax for at least 2 cycles;
Exclusion criteria
✕. Diagnosis of chronic myelogenous leukemia in blast crisis;
✕. Prior hematopoietic stem cell transplantation (this exclusion applies for dose escalation Part 1 and Cohort A of Part 2);
✕. For patients in Cohort B of Part 2, prior hematopoietic stem cell transplantation is allowed under certain circumstances.
✕
What they're measuring
1
Number of participants with Dose Limiting Toxicities (DLT)
. Treatment with anticancer medications, investigational drugs or radiotherapy is allowed within 2 weeks or 5 half-lives prior to start of MCLA-117;
✕. Previous receipt of live vaccines in the 4 weeks prior to study drug administration;
✕. Chronic concurrent need of use of corticosteroids \> 10 mg/day of oral prednisone or the equivalent, except topical preparations (e.g., topical creams, steroid inhaler, nasal spray or ophthalmic solution);
✕. Use of immunosuppressant medications within 4 weeks of MCLA-117 administration;
✕. Clinically active central nervous system (CNS) leukemia;