← Back to all trials
Completed
NCT03588078
Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine
Conditions: Myelodysplastic Syndrome With Gene Mutation, Acute Myeloid Leukemia With Gene Mutations, Myeloproliferative Neoplasm, Chronic Myelomonocytic Leukemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 53
Sponsor: Groupe Francophone des Myelodysplasies
Location: Bruno Quesnel Lille
Summary
The main purpose of this study is to determine the safe and efficacy of APR-246 in combination with azacitidine as well as to see complete remission of this patients
Eligibility Criteria
Inclusion Criteria:
1. Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements.
2. Patient has adequate organ function as defined by the following laboratory values:
1. Serum creatinine ≤ 2 x upper limit of normal (ULN)
2. Total serum bilirubin \< 1.5 x ULN or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome or hemolysis or who required regular blood transfusions
3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN
3. Age ≥18 years at the time of signing the informed consent form
4. Documented diagnosis of myelodysplastic syndrome (MDS), MDS/ myeloproliferative neoplasm (MPN), chronic myelomonocytic leukemia (CMML) by World Health organization (WHO) criteria or non-proliferative AML (ie with WBC \< 20 G/l)
5. Documentation of a TP53 gene mutation by next-generation sequencing (NGS) based on central or local evaluation.
6. Revised International Prognostic Scoring System (IPSS-R) criteria for Intermediate, High-risk or Very High-risk.
7. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 is required.
8. If of childbearing potential, negative pre-treatment urine or serum pregnancy test.
9. If of childbearing potential (males and females), willing to use an effective form of contraception such as latex condom, hormonal birth control, intrauterine device or double barrier method during chemotherapy treatment and for at least six months thereafter.
Exclusion Criteria:
1. Patient has a known history of HIV or active hepatitis B or active hepatitis C infection (testing not mandatory).
2. Patient has any of the following cardiac abnormalities (as determined by treating MD):
1. symptomatic congestive heart failure
2. myocardial infarction ≤ 6 months prior to enrollment
3. unstable angina pectoris
4. serious uncontrolled cardiac arrhythmia
5. QTc ≥ 470 msec (≥ 500 msec in the presence of RBBB) calculated from a mean of 3 ECG readings using Fridericia's correction (QTcF = QT/RR0.33)
6. bradycardia (\
Source: ClinicalTrials.gov (NCT03588078). StuddyBuddy aggregates publicly available trial information.