Etude : FILOCLL09 IDA53 / IDA53

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Type d'étude
Présentation de l'étude
Acronyme : FILOCLL09 IDA53

Nom : IDA53

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 24/01/2020
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.
Selection period (before starting treatment): exams performing to verify patients' eligibility.

Collection of the medical history,
Clinical examination with measurement of height and weight, vital signs (temperature, pulse / heart rate, blood pressure),
Conventional blood tests to check all the functions of the body such as kidney, liver, etc
Viral serologies (Human Immunodeficiency Virus (HIV) and hepatitis B and C) (10 ml).
Blood Pregnancy Test for women who may have children,
Specific blood tests to evaluate the disease and in particular to characterize the cells of LLC (mutational profile, search for chromosomal abnormalities and analysis of residual disease rate to have a reference point before the start of treatment will be made on leukemic cells),
CT scan (thorax, abdomen and pelvis) to accurately search for and evaluate a deep tumor syndrome (lymph nodes, spleen in particular),
Urine examination,
Cardiological examination with an electrocardiogram (ECG)..
Treatment period: the treatment period is divided into successive cycles of 28 days.

Before starting ibrutinib and before each daratumumab cycle, a complete clinical examination and blood work will be performed.

After 12 months of treatment, an evaluation report will be made with a complete clinical examination, a complete blood test, an urinalysis if necessary, a Computed Tomography (CT) scan, a myelogram and if necessary a marrow biopsy. Regularly after this assessment (every 6 months until the end of the study), a report will be made with clinical examination, complete blood test, ECG, CT scan and if necessary, myelogram possibly associated with a marrow biopsy if justified and not previously carried out.

After the end of the protocol treatment (progression of the disease, intolerance of the protocol treatment), a last evaluation will be carried out within 30 days after the last taking of the protocol treatment. This evaluation includes a complete clinical examination, biological tests (complete blood test) and a CT scan.

Follow-up period the completed treatment you will then be followed in consultation every 6 months for 2 years to evaluate the duration of the response to treatment and thus meet the objectives of the study.

Phase : II

Stade : NA

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 :
Centre Henri Becquerel - Rue d'Amiens CS 11516 - Cedex 1 - 76000 ROUEN

Investigateur :

Sandrine VAUDAUX

Statut de l'essai : OUVERT

MAJ : 24/01/2020