Lenalidomide Plus Rituximab (R) in Non Follicular NHL

NCT01830478 | Unknown Phase 2

• 1 other identifier: INFL08
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether lenalidomide in association with rituximab is effective in the treatment of patients with indolent non follicular NHL relapsed after \>=2, but less than 4 prior lines of (immuno)chemotherapy.

Conditions

Indolent Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Assess the efficacy

  Evaluate the efficacy in term of Overall Response Rate (Complete Response + Partial Response) and Tumour Control Rate (Complete Response + Partial Response + Stable Disease)

  Two weeks after the completion of Rituximab + Lenalidomide

Secondary Outcomes (1)

• Assess the safety

  From start of treatment for all follow up period (18 months)

Study Arms (1)

Lenalidomide and Rituximab

EXPERIMENTAL

Lenalidomide 20 mg once daily on days 1-21 of 28 days cycle for up to 6 courses and Rituximab 375 mg/m2 at day 14 of every course.

Drug: Lenalidomide; Drug: Rituximab

Interventions

Lenalidomide DRUG

Lenalidomide 20 mg p.o. once daily, days 1-21 every 28 days, for 6 cycles

Also known as: Revlimid

Lenalidomide and Rituximab

Rituximab DRUG

Rituximab 375 mg/m2 intravenously, day 14 of every course for 6 cycles

Also known as: Mabthera

Lenalidomide and Rituximab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmed diagnosis of B-Cell non follicular NHL according to REAL/WHO Classification: small lymphocytic lymphoma, lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia, nodal marginal zone lymphoma, splenic marginal zone lymphoma, extranodal non-gastric marginal zone lymphoma
• Availability of tissue biopsy mandatory when suspected pathological sites (nodal or extranodal) are easily accessible and in presence of extranodal non-gastric marginal or nodal marginal zone lymphoma diagnosis. In the other cases bone marrow biopsy, when representative, may be considered sufficient for defining lymphoma histotype
• Disease relapsing after \>=2, but less than 4 prior lines of (immuno)chemotherapy. At least one of previous treatment had to include rituximab
• Presence of at least one of the following criteria for the definition of active disease: systemic symptoms, bulky disease, progressive marrow failure and/or splenomegaly and/or lymph adenopathy
• Age 18-75
• Life expectancy \> 6 months
• Eastern Cooperative Oncology Group (ECOG) \<=2
• Left ventricular ejection fraction (LVEF) \>=45%
• Creatinine clearance \>= 50 mL/min calculated by Cockcroft-Gault estimation; patients with creatinine clearance \>= 30 and \< 50 mL/min, at physician discretion could enter the study starting at lenalidomide dose level -2 (10 mg)
• Total bilirubin up to 2 x upper limit of normal(ULN). Total bilirubin values higher than 2 x ULN are admitted if related to localization of the disease
• Alkaline phosphatase up to 2 x ULN and transaminases up to 3 x ULN
• Female and male patients must agree to participate in pregnancy prevention program signing informed Consent (paragraph 5.4.)
• Written informed Consent

You may not qualify if:

• Previously untreated patients
• Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL)
• Women and men not agreeing to take adequate contraceptive precautions during and for at least 4 weeks after cessation of therapy
• Pregnant or lactating women
• History of other malignancies within 3 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer, low grade, early stage localized prostate cancer treated surgically with curative intent, good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent
• Active bacterial, viral or fungal infection requiring systemic therapy
• Concurrent co-morbid medical condition which might exclude administration of therapy
• Cardiac insufficiency (NYHA grade III/IV)
• Myocardial infarction within 6 months of entry on the study
• Severe chronic obstructive pulmonary disease with hypoxemia
• Severe diabetes mellitus difficult to control with adequate insulin therapy
• Hypertension that is difficult to control
• Creatinine clearance \< 30 mL/min calculated by Cockcroft-Gault estimation
• Absolute neutrophil count (ANC) \<= 1 x 109/L, unless due to lymphoma involvement and not responding to 5 days of Granulocyte colony-stimulating factor (G-CFS) treatment
• Platelets count \<=75.000/mm3, unless due to lymphoma involvement

Sponsors & Collaborators

• Gruppo Italiano Studio Linfomi: lead

Study Sites (1)

Centro Oncologico Modenese

Modena, MO, 41124, Italy

Location

MeSH Terms

Interventions

Lenalidomide; Rituximab

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Stefano Sacchi, MD

  Gruppo Italiano Studi Linfomi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 12, 2013
• Study Start: April 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: October 1, 2014
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

IT (1)