Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation

  • STATUS
    Recruiting
  • End date
    Jan 8, 2024
  • participants needed
    48
  • sponsor
    Tian Yi Zhang
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Updated on 8 June 2022
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anemia

Summary

This is a phase 1b/2, open-label, single arm study to evaluate if enasidenib is safe and effective in improving anemia and decreasing transfusion needs in subjects diagnosed with lower risk myelodysplastic syndrome (MDS) or nonproliferative chronic myelomonocytic leukemia (CMML) without a mutation in isocitrate dehydrogenase type 2 (IDH2 wildtype). Other objectives include assessment of improvements in platelet production and characterization of the mechanism of action of enasidenib in enhancing endogenous erythropoiesis.

Description

Primary Objective(s)- To determine the efficacy (response rate) of enasidenib in improving anemia and decreasing RBC transfusion dependence.

Secondary Objective(s)- To determine the tolerability, safety and durability of the erythroid response and identify laboratory parameters as clinical markers of response.

Details
Condition Leukemia, Leukemia, Myeloid, Monocytic Leukemia
Treatment Enasidenib mesylat dose escalation
Clinical Study IdentifierNCT05282459
SponsorTian Yi Zhang
Last Modified on8 June 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Documented diagnosis of 1) MDS according to WHO/FAB classification that meets IRSS-R classification of very low or lower risk disease; and a diagnosed as de novo or secondary MDS (MDS RS eligible if refractory to or declined luspatercept therapy)
OR 2) Dysplastic (nonproliferative) CMML with WBC <13.0/microL)
No disease modifying therapy (HMA, hydrea) within 2 months of starting study
Age ≥ 18 years of age
ECOG ≤ 3
Negative for IDH2 mutation by NGS or multiplex PCR (SNaPshot)
Has symptomatic anemia defined as hemoglobin < 10.0 g/dL with any of the following
oTachypnea oShortness of breath oFatigue oMalaise oWorsening of
cardiovascaular function oAsthenia oDyspnea on exertion oAngina oOther subject
symptoms the subject reports as being associated with being anemic
Stated willingness to comply with all study procedures and availability for the duration of the study
Ability to take oral medication and be willing to adhere to the medication regimen
Females of reproductive potential need to either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with highly effective contraception without interruption, 28 days prior to starting enasidenib, during the study therapy, and for 30 days after last dose of enasidenib
For males of reproductive potential: agreement to use of condoms
Adequate organ function defined as
Hepatic function: total bilirubin <1.5 x ULN (unless attributable to Gilbert's disease), AST or ALT < 3x ULN
Renal function: creatinine clearance >30 mL/minute, calculated by Cockcroft-Gault formula
Ability to understand and the willingness to sign the IRB approved informed consent
document
Women of childbearing potential must have negative urine or serum pregnancy test

Exclusion Criteria

Use of concurrent other erythropoietic agents (including epoetin, darbepoetin), G-CSF within 30 days of study enrollment
Less than 3 months of life expectancy
Treatment with iron chelation therapy within 56 days of study start
Significant cardiac disease (NYHA Class IV congestive heart failure, or unstable angina or myocardial infarction within the last 6 months
Harbor IDH2 somatic mutations by NGS or PCR
Pregnant or breast feeding
Any uncontrolled bacterial, fungal, viral or other infection
No known HIV+ or active hepatitis B or C infection, defined as positive viral load for HBV or HCV or a positive surface antigen (HBsAg) test for hepatitis B
Have other causes of anemia: deficiencies in iron, B12, folate; nutritional deficiencies related to gastric surgery, anorexia nervosa, excessive zinc supplementation; gastrointestinal bleed. If nutritional deficiencies can be corrected, potential participant can be rescreened and enrolled if nutritionally replete and still meets eligibility criteria
Any other medical history, including laboratory results, deemed by the Principal Investigator likely to interfere with their participation in the study, or to interfere with the interpretation of the results
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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