Phase I Study of S64315 Administred Intravenously in Patients With Acute Myeloid Leukaemia or Myelodysplastic Syndrome

Completed · Phase 1

Conditions studied: Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS)

In brief

The CL1-64315-001 study is a phase I, international, multicentre, open-label, non-randomised, non-comparative study. This study is designed in two parts: one part for dose escalation, one part for dose expansion.

Key facts

Study ID

NCT02979366

Run by

Institut de Recherches Internationales Servier

People needed

38

Starts

2017-03-15

Expected to finish

2020-05-11

Last updated by the study team

2022-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged ≥ 18 years;
• Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML, 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 or
• > 65 years not previously treated for AML and who are not candidates for intensive chemotherapy nor candidates for established alternative chemotherapy Or Patients with cytologically confirmed and documented MDS), in relapse or refractory after previous treatment line including at least one hypomethylating agent and have ≥10% bone marrow blasts;
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Circulating white blood cells < 10\^9 /L (with or without use of hydroxycarbamide).
• Adequate renal function defined as:
• Serum creatinine ≤ 1.5 x ULN (upper normal limit) or calculated creatinine clearance (determined by MDRD) > 50 mL/min/1.73m2.
• LDH < 2 x ULN
• Adequate hepatic function defined as:
• AST and ALT ≤ 1.5 x ULN
• Total bilirubin level ≤ 1.5 x ULN, except for patients with known Gilbert's syndrome (confirmed by the UGT1A1 polymorphism analysis), who are excluded if total bilirubin>3.0 x ULN or direct bilirubin > 1.5 x ULN
• Serum CK/CPK ≤2.5 x ULN.

You may not qualify if…

• Unlikely to cooperate in the study.
• Participant already enrolled in the study who has received at least one S64315 infusion.
• Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
• Participation in another interventional study requiring investigational treatment intake within 2 weeks or at least 5 half-lives (whichever is longer) prior to first dose of S64315 (participation in non-interventional registries or epidemiological studies is allowed).
• 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 (NCI-CTCAE, version 4.03)
• Unresolved ≥ CTCAE grade 2 diarrhoea or medical conditions associated with chronic diarrhoea (such as irritable bowel syndrome, inflammatory bowel disease)
• Known carriers of HIV antibodies
• Known history of significant liver disease
• Uncontrolled hepatitis B or C infection
• Known active or chronic pancreatitis
• History of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment.

Where it is running

• Patient Care Location: Smilow Cancer Hospital at Yale — New Haven, Connecticut, United States
• The University of Texas MD Anderson Cancer Center, Department of Leukemia, Division of Cancer Medicine — Houston, Texas, United States
• The Alfred Hospital Department of Haematology — Melbourne, Australia
• Royal Melbourne Hospital, Department of Clinical Haematology and BMT Service — Melbourne, Australia
• Institut Paoli-Calmettes Departement d'Hématologie — Marseille, France
• Hôpital Saint-Antoine Département d'Hematologie Clinique et de Thérapie cellulaire — Paris, France
• Institut Universitaire du Cancer Toulouse Oncopole — Toulouse, France
• Hospital Universitario Vall d' Hebron/VHIO Hematology Department — Barcelona, Spain
• Hospital Universitario La Fe Hematology Department — Valencia, Spain

Full record on ClinicalTrials.gov

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