BTK inhibitors relapsed-refractory or intolerant mantle cell lymphomas MedDRA version: 20.0 Level: PT Classification code 10061275 Term: Mantle cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: REVLIMID
Product Name: REVLIMID/LENALIDOMIDE
Product Code: [IMP1 - 5 MG]
Pharmaceutical Form: Capsule, hard
Current Sponsor code: Fondazione Italiana Linfomi Onlus
Concentration unit: mg m
Sponsors
FONDAZIONE ITALIANA LINFOMI ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient has a confirmed diagnosis of MCL according to the WHO 2017 classification; • Previous treatment with BTKi monotherapy or BTKi containing regimens with R/R disease; and/or patients who discontinued BTKi monotherapy or BTKi containing regimens for adverse events and have active disease necessitating treatment; • Previous treatment with Lenalidomide is accepted if patient resulted responsive and interrupted Lenalidomide at least 12 months before enrollment to this study; • Patient age is = 18 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement by MCL; • Total bilirubin up to 2 x ULN unless due to liver involvement by MCL; • Alkaline phosphatase and transaminases up to 2 x ULN unless due to liver involvement by MCL; • Creatinine clearance = 30 ml/min; a dose reduction of Lenalidomide for patients with creatinine clearance = 30 mL/min but =65 years) yes F.1.3.1 Number of subjects for this age range 29
Exclusion criteria
Exclusion criteria: • Patient who have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study; • Patient has a history of CNS involvement with lymphoma; • Patient with previous history of malignancies (apart MCL) = 3 years before study accrual with the exception of currently treated basal cell and squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix; • History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances; • Patient has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, uncontrolled hypertension, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), active hemorrhage, psychiatric illness, active or uncontrolled infection that in the investigator opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form; • Creatinine clearance 2000 UI/ml is criteria of exclusion; - patient is HBsAg – HBsAb +; - patient is HBsAg – but HBcAb + • Patient with HCV active hepatitis are excluded from the study. Patient with no evidence of active hepatitis and/or advanced chronic liver disease according to liver biopsy or fibro-scan evaluation may be included into the study; • Previous treatment with Lenalidomide if patient resulted primary refractory to Lenalidomide or interrupted Lenalidomide less than 12 months before enrollment to this study; • Women who are pregnant or breast-feeding; • Known hypersensitivity to the active substances or to any of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective - To evaluate the antitumor efficacy of the association of KRD in terms of 12-month overall survival (OS).;Secondary Objective: Secondary Objectives To evaluate: - Overall response rate (ORR); Complete response (CR), Partial response (PR) and Stable Disease (SD) rate; - Effect of treatment on overall progression free survival (PFS); - Effect on long term OS; - Time to response (TTR); - Duration of treatment (DoT); - Safety profile of the combination.;Primary end point(s): 12-month OS;Timepoint(s) of evaluation of this end point: the probability of survival from the start date of treatment to 12 months, based on the Kaplan-Meier evaluation method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ORR, CR, PR and SD rate; PFS ( progression free survival); OS;Timepoint(s) of evaluation of this end point: The overall response rate, complete (CR), partial (PR) and stable disease (SD) responses will be defined according to the Lugano 2014 criteria. The best overall response will be defined as the best maximum response between the start date of the therapy and the last evaluation. Patients without a response assessment (for any reason) will be considered non-responders.; PFS will be defined as the time from the start of therapy to the date of recurrence, progression or death for any cause; Patients who respond and patients who are lost to follow-up will be censored on their last evaluation date.; OS will be defined as the time from the date of initiation of therapy to the date of death for any cause; patients who are lost to follow-up will be censored on their last evaluation date | — |
Countries
Italy, Netherlands, Poland, Spain, United Kingdom
Contacts
Public ContactUFFICI STUDI FIL
FONDAZIONE ITALIANA LINFOMI ONLUS
Outcome results
None listed