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Accueil » Trouver des essais cliniques » Study of a New Intravenous Drug, Called S65487, in Patients With Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia

Study of a New Intravenous Drug, Called S65487, in Patients With Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia

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Code de protocole Servier: CL1-65487-002 Sponsor: Institut de Recherches Internationales Servier Identifiant Clinicaltrials.gov: NCT03755154 Numéro EudraCT: 2018-004170-97

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Comment participer à cette étude
Si vous pensez être éligible pour cette étude (voir
critères d'éligibilité
ci-dessous), vous pouvez identifier le site le plus proche de chez vous et le contacter directement. Si vous ne trouvez pas de site près de chez vous, veuillez contacter l'Institut de Recherches Internationales Servier (I.R.I.S.).
Nom: Institut de Recherches Internationales Servier, Département des études cliniques
Numéro de téléphone: +33 1 55 72 60 00
L'étude a 11 centres

Description de l'étude

This study is designed in two parts: one part for dose escalation, one part for dose expansion.The dose escalation part will be followed by expansion part at the MTD(s)/RP2D(s)

This study will utilize an adaptative Bayesian Logistic Regression model to guide dose escalation and estimate the MTD(s) based on the Dose Limiting Toxicity (DLT) relationship(s) for S65487 in the indications.
Titre officiel: Phase I, Open Label, Non-randomised, Non-comparative, Multi-center Study, Evaluating S65487, a Bcl-2 Inhibitor Intravenously Administered, in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia
Indications
Relapsed or Refractory Acute Myeloid Leukemia Relapsed or Refractory Non-Hodgkin Lymphoma Relapsed or Refractory Multiple Myeloma Relapsed or Refractory Chronic Lymphocytic Leukemia
Interventions / Traitements
  • S65487- initial scheme
  • S65487 - alternative scheme
Autres numéros d'identification
  • CL1-65487-002

Critères d'éligibilité

Age éligible pour l’étude

18 ans et plus (Adulte, Adulte plus âgé)

Sexe

Homme/Femme

Accepte les volontaires en bonne santé

Non

  • * Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML, excluding acute promyelocytic leukaemia with relapsed or refractory disease without established alternative therapy. Or patients with measurable confirmed Multiple Myeloma (IMWG) with relapsed or refractory disease who have previously received at least three lines of treatment and without established alternative therapy. Or patients with histologically and measurable confirmed Non Hodgkin Lymphoma defined as Diffuse Large B cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), High-Grade B cell Lymphoma with relapsed or refractory disease who have received at least two lines of therapy (including rituximab) and without established alternative therapy. Or patients with Chronic Lymphocytic Leukemia (CLL) who have relapsed or are refractory (except treatment failure), as defined per iwCLL, from venetoclax treatment and without established alternative therapy.
  • * ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
  • * For NHL, MM patients and CLL patients: haematological function (independent of any growth factor support) based on the last assessment performed before inclusion, defined as: absolute neutrophil count (ANC) ≥ 1 x 109/L, haemoglobin ≥ 8 g/dL, platelet count ≥ 50 x 109/L for NHL and MM patients, platelet count ≥ 30 x 109/L for CLL patients.
  • * For AML patients: circulating Blood White Cell count (WBC count) < 25 x 109/L (with or without use of hydroxycarbamide/leukapheresis) based on the last assessment performed before inclusion.
  • * Adequate renal function based on the last assessment performed before inclusion, assessed as Glomerular Filtration Rate (GFR) using Modification of Diet in Renal Disease (MDRD) Formula.
  • * Adequate hepatic function based on the last assessment performed before inclusion.

  • * Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
  • * Participation in another interventional study at the same time or another interventional study requiring investigational treatment intake within 3 weeks or at least 5 half-lives (whichever is longer) prior to the first S65487 administration.
  • * Participant already enrolled in the study (informed consent signed) and has received at least one dose of S65487.
  • * Patients who have not recovered from toxicity of previous anticancer therapy, including grade ≥ 2 non-hematologic toxicity, prior to the first IMP administration (including peripheral neurotoxicity). Certain toxicities will not be considered in this category (e.g. alopecia).
  • * Patients refractory to a previous treatment with a Bcl-2 inhibitor.
  • * For AML patients : Allogenic stem cell transplant within 3 months before the first IMP administration and/or patients who still receive immunosuppressive treatment within 3 months before the first IMP administration and/or patients with active Graft-versus-host disease within 3 months before the first IMP administration and/or patient who receive donor lymphocyte infusion (DLI) within 3 months before the first IMP administration.
  • * For NHL, MM and CLL patients : Prior allogenic stem cell transplant before the first IMP administration and/or Autologous stem cell transplant within 3 months before the first IMP administration.

Comment l'étude est-elle conçue ?

Allocation
Non randomisé
Modèle d'étude interventionnelle
Parallèle
Groupe de participants / Bras de traitement
Expérimental: S65487 - initial scheme
Intervention / Traitement
Traitement: S65487- initial scheme
S65487 is administered as single agent via i.v. infusion once a week on a 3-week cycle.
Groupe de participants / Bras de traitement
Expérimental: S65487 - alternative scheme
Intervention / Traitement
Traitement: S65487 - alternative scheme
S65487 is administered in 3 to 5 i.v. infusions the first week of each cycle then once a week on the rest of the 3-week cycle.

Mots clés

Fournis par Servier
Leukemia Lymphoma Myeloma Dose-escalation
Autres termes
Recurrence Leukemia, Myeloid, Acute Lymphoma, Non-Hodgkin Multiple Myeloma Leukemia, Lymphocytic, Chronic, B-Cell Leukemia Lymphoma Neoplasms, Plasma Cell