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Closed (no longer recruiting)Last updated: 7 February 2024

This phase I trial is evaluating the combination of a new intravenous drug (S64315) and an oral chemotherapy drug (venetoclax) in patients with Acute Myeloid Leuakemia (AML)An International Phase Ib Multicentre Study to Characterize the Safety and Tolerability of Intravenously Administered S64315 a Selective Mcl-1 Inhibitor, in Combination With Orally Administered Venetoclax a Selective Bcl-2 Inhibitor in Patients With Acute Myeloid Leukaemia

Clinical summary

Conditions

This trial is treating patients with Acute Myeloid Leukaemia (AML).

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Servier

Scientific Title

An International Phase Ib Multicentre Study to Characterize the Safety and Tolerability of Intravenously Administered S64315 a Selective Mcl-1 Inhibitor, in Combination With Orally Administered Venetoclax a Selective Bcl-2 Inhibitor in Patients With Acute Myeloid Leukaemia

Eligibility

Inclusion

  1. Male or female aged ≥ 18 years;
  2. Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML as defined by World Health Organization (WHO) 2016 classification (Arber, 2016), excluding acute promyelocytic leukaemia (APL, French-American British M3 classification):

    • With relapsed or refractory disease without established alternative therapy or
    • Secondary to MDS treated at least by hypomethylating agent and without established alternative therapy or
    • ≥ 65 years not previously treated for AML and who are not candidates for intensive chemotherapy nor candidates for established alternative therapy
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  4. Able to comply with study procedures
  5. Adequate renal function within 7 days before the inclusion of the patient defined as:

    • Serum creatinine ≤ 1.5 x ULN (upper normal limit) or calculated creatinine clearance (determined by MDRD) > 50 mL/min/1.73m2

  6. Adequate hepatic function within 7 days before the inclusion of the patient defined as:

    • AST and ALT ≤ 1.5 x ULN
    • Total serum bilirubin level ≤ 1.5 x ULN, except for patients with known Gilbert's syndrome, who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN

Exclusion

  1. Participant already enrolled and treated in the study
  2. Pregnancy, breastfeeding or possibility of becoming pregnant during the study
  3. Participation in another interventional study requiring investigational treatment intake at the same time or within 2 weeks or at least 5 halflives (whichever is longer) prior to first dose of IMP (participation in non-interventional registries or epidemiological studies is allowed). In case of biologic agents with a long half life such as CART cells, immune checkpoint antibodies, bispecific antibodies a flat wash-out of 28 days will be acceptable
  4. Presence of ≥ CTCAE Grade 2 toxicity (except alopecia of any grade) due to prior cancer therapy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE, version 4.03).
  5. Known carriers of HIV antibodies
  6. Known history of significant liver disease
  7. Uncontrolled hepatitis B or C infection
  8. Known active acute or chronic pancreatitis
  9. History of myocardial infarction (MI), unstable angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment
  10. Any factors that could increase the risk of QTc prolongation or risk of arrhythmic events.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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