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

FONDAZIONE ITALIANA LINFOMI ONLUS0 sites42 target enrollmentJune 8, 2012

ConditionsPatients 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]

DrugsREVLIMID LEVACT*5FL 100MG 2,5MG/ML

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with first relapsed/refractory mantle cell lymphoma (MCL)
Sponsor: FONDAZIONE ITALIANA LINFOMI ONLUS
Enrollment: 42
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 8, 2012

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

FONDAZIONE ITALIANA LINFOMI ONLUS

Eligibility Criteria

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.