Phase I/II trial of S65487 plus azacitidine in acute myeloid leukemia

Phase 1

Active, not recruiting

• Conditions: Previously untreated Acute Myeloid Leukemia (AML); MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003061-19-FR
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-16
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. Male or female participant aged = 18 years old according to section 5.1.2
2. Participants with cytologically confirmed and documented treatment naïve, de novo or secondary AML defined by WHO 2016 classification (Arber, 2016). Secondary AML includes:
a. Previous myelodysplastic syndrome transformed
b. AML due to exposure to potentially leukemogenic therapies or agents (e.g. radiation therapy, alkylating agents, topoisomerase II inhibitors) with the primary malignancy in remission for at least 3 years
3. Participants not eligible for standard induction chemotherapy
a. Aged = 75 years old
b. Or Age =18 years with at least one of the following comorbidities:
i. Clinically significant heart or lung comorbidities, as reflected by at least one of:
- Lung diffusing capacity for carbon monoxide (DLCO) =65% of expected
- Forced expiratory volume in 1 second (FEV1) =65% of expected
ii. Other contraindication(s) to anthracycline therapy (must be documented)
iii. Other comorbidity that the Investigator judges as incompatible with intensive remission induction chemotherapy, which must be documented
4. ECOG (Eastern Cooperative Oncology Group) performance status should be (criterion should be rechecked at inclusion visit) ECOG = 2.
5. Written informed consent obtained prior any study-specific procedure as described in section 13.3 of the protocol.
6. Adequate renal and hepatic function
7. Circulating White Blood Cell Count (WBC count) < 25*109 G/L (with or without use of hydroxycarbamide/leukapheresis)
8. Serum potassium, serum calcium, serum phosphates, serum magnesium within normal limits with or without supplementation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 73

Exclusion Criteria

9. Major surgery within 3 weeks prior to the first IMP administration, or participants who have not recovered from side effects of the surgery
10. Any radiotherapy within 3 weeks before the first IMP administration,
11. Allogenic stem cell transplant within 3 months before the first IMP administration and/or participants with active Graft-versus-host disease within 3 months before the first IMP administration and/or participants who still receive immunosuppressive treatment within 3 months before the first IMP administration and/or participant who receive donor lymphocyte infusion (DLI) within 3 months before the first IMP administration
12. Acute promyelocytic leukemia (APL, French-American-British M3 classification)
13. Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;17) as per the National Comprehensive Cancer Network (NCCN) Guidelines Version 2, 2016 for Acute Myeloid Leukemia
14. Treatment with hypomethylating agents (decitabine/azacitidine) or Venetoclax for AHD (antecedent hematologic disorders) in the 3 months prior to the first IMP intake

Study & Design

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