First in Human Testing of Dose-escalation of SAR440234 in Patients with Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome

Phase 1

• Conditions: eukaemia; MedDRA version: 20.1Level: PTClassification code 10024288Term: LeukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-004148-39-FR
• Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-21
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

- Confirmed diagnosis of Acute Myeloblastic leukemia (AML) (except acute promyelocytic leukemia), or myelodysplastic syndrome (MDS) with a risk category of intermediate or higher.
- Patients with AML must be unlikely to benefit from cytotoxic chemotherapy.
- Patients with B-ALL (B acute lymphoid leukemia) in second or subsequent relapse.
- Patients with HR-MDS (high risk myelodysplastic syndrome) must have received =1 cycle of hypomethylating therapy or induction therapy and have =10% bone marrow blasts.
- Signed written informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- Age <16 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status >2.
- Patients with inadequate biological tests.
- Graft-versus-host disease following allogeneic stem cell transplantation requiring treatment with more than 10 mg of oral prednisone or equivalent daily. The stem cell transplant and/or donor lymphocyte infusion should have been performed more than 3 months before study treatment start.
- Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
- Previous treatment with radiotherapy or immunotherapeutic agents in the 4 weeks prior to IMP administration
- Previous treatment with any other investigational agent in the 4 weeks prior to IMP administration
- Receiving, at the time of first IMP administration, of concurrent steroids >10 mg/day of oral prednisone or the equivalent for =3 months
- Requirement for tociluzimab for any other diagnosis.
- Evidence of active central nervous system leukemia at the time of enrollment.
- Acquired immunodeficiency syndrome (AIDS-related illnesses) or HIV disease requiring antiretroviral treatment.
- Active hepatitis B viral infection or hepatitis C viral infection; HIV infection.
- Women of childbearing potential, male with a partner of childbearing potential who do not agree to use effective methods of birth control.
- Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the patient or may interfere with compliance or interpretation of the study results.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified