Informations générales (source: ClinicalTrials.gov)
Phase I / II, Open Label, Dose Escalation Part (Phase I) Followed by Non-comparative Expansion Part (Phase II), Multi-centre Study, Evaluating Safety, Pharmacokinetics and Efficacy of S65487, a Bcl2 Inhibitor Combined With Azacitidine in Adult Patients With Previously Untreated Acute Myeloid Leukemia Not Eligible for Intensive Treatment
Interventional
Phase 1/Phase 2
Institut de Recherches Internationales Servier (Voir sur ClinicalTrials)
mars 2021
décembre 2025
12 avril 2025
The purpose of this study is to assess the safety, tolerability and clinical activity of
the combination S65487 with azacitidine in patients with acute myeloid leukaemia.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | St�phane DE BOTTON | 20/06/2024 08:46:28 | Contacter | ||
Critères
Tous
Inclusion Criteria:
- Male or female participant aged ≥ 18 years old
- Participants with cytologically confirmed and documented treatment naïve, de novo or
secondary AML defined by WHO 2016 classification (Arber, 2016). Secondary AML
includes:
- Previous myelodysplastic syndrome transformed
- 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
- Participants not eligible for standard induction chemotherapy
- Aged ≥ 75 years old
- Or Age ≥18 years with at least one of the following comorbidities:
- 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
- Other contraindication(s) to anthracycline therapy (must be documented)
- Other comorbidity that the Investigator judges as incompatible with
intensive remission induction chemotherapy, which must be documented
- ECOG (Eastern Cooperative Oncology Group) performance status should be (criterion
should be rechecked at inclusion visit) ECOG ≤ 2.
- Written informed consent obtained prior any study-specific procedure as described in
section 13.3 of the protocol.
- Adequate renal and hepatic function
- Circulating White Blood Cell Count (WBC count) < 25*109 G/L (with or without use of
hydroxycarbamide/leukapheresis)
- Serum potassium, serum calcium, serum phosphates, serum magnesium within normal
limits with or without supplementation.
- Male or female participant aged ≥ 18 years old
- Participants with cytologically confirmed and documented treatment naïve, de novo or
secondary AML defined by WHO 2016 classification (Arber, 2016). Secondary AML
includes:
- Previous myelodysplastic syndrome transformed
- 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
- Participants not eligible for standard induction chemotherapy
- Aged ≥ 75 years old
- Or Age ≥18 years with at least one of the following comorbidities:
- 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
- Other contraindication(s) to anthracycline therapy (must be documented)
- Other comorbidity that the Investigator judges as incompatible with
intensive remission induction chemotherapy, which must be documented
- ECOG (Eastern Cooperative Oncology Group) performance status should be (criterion
should be rechecked at inclusion visit) ECOG ≤ 2.
- Written informed consent obtained prior any study-specific procedure as described in
section 13.3 of the protocol.
- Adequate renal and hepatic function
- Circulating White Blood Cell Count (WBC count) < 25*109 G/L (with or without use of
hydroxycarbamide/leukapheresis)
- Serum potassium, serum calcium, serum phosphates, serum magnesium within normal
limits with or without supplementation.
- Major surgery within 3 weeks prior to the first IMP administration, or participants
who have not recovered from side effects of the surgery
- Any radiotherapy within 3 weeks before the first IMP administration,
- 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
- Acute promyelocytic leukemia (APL, French-American-British M3 classification)
- 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 3, 2019 for
Acute Myeloid Leukemia
- Treatment with hypomethylating agents (decitabine/azacitidine) or Venetoclax for AHD
(antecedent hematologic disorders) in the 3 months prior to the first IMP intake