BENDAMUSTINE, LENALIDOMIDE AND RITUXIMAB (R2-B)COMBINATION AS A SECOND-LINE THERAPY FOR FIRST RELAPSED-REFRACTORY MANTLE CELL LYMPHOMAS: A PHASE II STUDY

Phase 1

• Conditions: Patients with first relapsed/refractory mantle cell lymphoma (MCL); MedDRA version: 14.1Level: HLTClassification code 10026798Term: Mantle cell lymphomasSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-005461-21-IT
• Lead Sponsor: FONDAZIONE ITALIANA LINFOMI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-08
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1-Patient has a diagnosis of MCL according to the WHO classification; 2-Patient age is = 18 years; 3-Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of = 2; 4-Understands and voluntarily signs an informed consent form; 5-Able to adhere to the study visit schedule and other protocol requirements; 6-Patients treated with one prior regimen and relapsed, or refractory to front line therapy; front line consolidation with autologous stem cell transplantation is considered to be part of first line therapy; 7-Patient has at least one site of measurable nodal disease at baseline = 2.0 cm in the longest transverse diameter as determined by CT scan (MRI is allowed only if CT scan can not be performed). Note: Patients with bone marrow involvement are eligible; 8-Adequate haematological counts: ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement by MCL; 9-Conjugated bilirubin up to 2 x ULN unless due to liver involvement by MCL; 10-Alkaline phosphatase and transaminases up to 2 x ULN unless due to liver involvement by MCL; 11-Creatinine clearance = 30 ml/min; a dose reduction of Lenalidomide for patients with creatinine clearance = 30 mL/min but < 50 mL/min is planned; 12-Written informed consent was obtained from the patient prior to any study-specific screening procedures; 13-Patient has the ability to swallow capsules or tablets; 14-Life expectancy = 6 months; 15-Male and Female patients: accordance to comply with Lenalidomide Risk Management Plan for pregnancy prevention.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1-Patients who have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in nontreatment studies is allowed, if it will not interfere with participation in this study; 2-Patient has a history of CNS involvement with lymphoma; 3-Patients with previous history of malignancies (a part MCL) = 3 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; 4-History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances; 5-Patient has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol; 6-Creatinine clearance < 30 ml/min; 7-Patient has a known history of HIV seropositivity; 8-Patient has active HBV hepatitis. The following categories of HBV positive patients but with non evidence of active hepatitis may be considered for the study and treated with R2-B (see also Section 8.1.8): - patient is HBsAg + with HBV DNA < 2000 UI/ml (inactive carriers); HBV DNA > 2000 UI/ml is criteria of exclusion; - patient is HBsAg – HBsAb +; - patient is HBsAg – but HBcAb + 9-Patients 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 (see also Section 8.1.9); 10-Patients have received previous treatment with either Bendamustine and/or Lenalidomide.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified