Etude : IDA53 / FILOCLL09

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Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : IDA53 / FILOCLL09

Situation thérapeutique : Induction

Traitement : Thérapie ciblée

Cadre réglementaire : RIPH1

Dernière MÀJ : 23/12/2021
CIM10 - Localisation(s)
Informations principales
Titre : Evaluation of the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia With p53 Dysfunction

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C92 - Leucémie myéloïde
Informations complémentaires
Schéma : This study will take place in several periods and phases of treatment:
- Observational period of selection of 28 days maximum
- Treatment period constituted:
-> a first phase of treatment with ibrutinib alone (28 days): pre-phase,
-> a formal protocol phase during which the two study drugs (ibrutinib and daratumumab) will be used together until progression of the disease or intolerance to treatment.
- 2-year follow-up period that will begin after protocol processing has been stopped.

On treatment arm:
- Experimental: Ibrutinib + daratumumab
-> Prephase (D-27 to D0): ibrutinib 420 mg/day
-> Cycle 1 (4 weeks): ibrutinib 420 mg/day from D1 to D28 + daratumumab 8 mg/kg D1 and D2, then 16 mg/kg at D8, D15, D22.
-> Cycle 2 (4 weeks): ibrutinib 420 mg/day D1 to D28 + daratumumab 16 mg/kg at D1, D8, D15 and D22.
-> Cycles 3 to 6 (4 weeks) : ibrutinib 420 mg/day D1 to D28 + daratumumab 16 mg/kg at D1 and D15.
-> Cycles ≥ 7 (4 weeks) : ibrutinib 420 mg/day D1 to D28 + daratumumab 16 mg/kg at D1.

Phase : II

Stade : NA

Rechute, Réfractaire
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Immunophenotypically confirmed diagnosis of CLL (criteria iwCLL Hallek et al. 2018)
- Progressive CLL according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
- Relapsed or refractory disease (≥ 1 previous line of treatment) with P53 genetic alteration (17p deletion and/or TP53 mutation).
- Age > 18 years
- Eastern Cooperative Oncology Group electrocorticogram (ECOG) status 0-2
- Negative serum pregnancy test one week prior to treatment for premenopausal women
- Cumulative Illness Rating Scale (CIRS) ≤ 6
- Life expectancy > 3 months.
- Possibility of follow-up
- Ability to understand the protocol
- Written informed consent of patient and treating physician

Critères de non-inclusion : - Previous treatment with ibrutinib.
- Patient refusal to perform bone marrow biopsy for evaluation point
- Prior other malignancy (except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥ 2 years).
- Known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) < 50 % of predicted normal. FEV testing is required for patients suspected of having COPD.
- Moderate or severe persistent asthma within the two last years or currently uncontrolled asthma of any classification (American Lung Association criteria). Current controlled intermittent asthma or controlled mild persistent asthma is not an exclusion criterion.
- Patients with active bacterial, viral, or fungal infection requiring systemic treatment.
- Patients with known infection with human immunodeficiency virus (HIV) or human T-lymphotropic virus type 1 (HTLV-1)
- Active B or C hepatitis (positive Hepatitis B Virus surface antigen (HBsAg) or Hepatitis B Virus (HBV) DNA for HBV; Positive Hepatitis C virus (HCV) RNA for HCV)
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation.
- Concomitant dual antiplatelet therapy
- Concomitant treatment with both antiplatelet and anticoagulation therapy
- Treatment with other investigational agent or participating to another trial within 30 days prior to entering the study
- Hemoglobin < 8 g/dL
- Absolute neutrophil count (ANC) < 1000/mm3
- Platelets < 30000/mm3
- Inadequate renal function: creatinine clearance < 50 ml/min (Cockcroft and Gault)
Inadequate liver function: Aspartate Transaminase (ASAT), Alanine aminotransferase (ALT) > 2.5 x Upper Limit of Normal (ULN)
- Total bilirubin > 1.5 x ULN unless rise is due to Gilbert's syndrome or of non-hepatic origin.
- Active auto-immune haemolytic anemia
- Richter's transformation
- Evidence of central nervous system (CNS) involvement
- Pregnant or breastfeeding women.
- -Adult under law-control
- Fertile male and female patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study
- No affiliate to social security
Informations relatives au promoteur
Promoteur :
French Innovative Leukemia Organisation
Type de sponsor : Institutionnel
CHU BRETONNEAU Centre Henry Kaplan Hématologie Cellulaire 2, Boulevard Tonnelé
37000 TOURS

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Institut d'Hématologie Bas-Normand (IHBN) - Avenue de la Cote de Nacre - 14000 CAEN

Investigateur :
Jean-Pierre VILQUE

Emmanuel GIRARD

Statut de l'essai : OUVERT

MAJ : 23/12/2020