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Lenalidomide Plus Rituximab (R) in Non Follicular NHL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01830478
Recruitment Status : Unknown
Verified April 2013 by Gruppo Italiano Studio Linfomi.
Recruitment status was:  Active, not recruiting
First Posted : April 12, 2013
Last Update Posted : April 12, 2013
Information provided by (Responsible Party):
Gruppo Italiano Studio Linfomi

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.

Condition or disease Intervention/treatment Phase
Indolent Non Hodgkin Lymphoma Drug: Lenalidomide Drug: Rituximab Phase 2

Detailed Description:
Single arm, multicenter, open-label study divided in two phases: 1. Induction phase; 2. Follow-up phase. Enrolled patients will start the induction phase and receive the courses of R-Lenalidomide. At the end of the third cycle of R-Lenalidomide (week 12 of the study), the patients will be evaluated for tumor response (complete assessment); the patients with Progressive Disease (PD) will be withdrawn of the study. Two weeks after the end last courses of R-Lenalidomide (week 26 of the study) patients will be evaluated for tumor response (complete assessment). Patients with Complete Response (CR) and Partial Response (PR), and with a stable disease will undergo the follow up phase, while patients with PD will be withdrawn of the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Lenalidomide in Combination With Rituximab (R) for the Treatment of Indolent Non Follicular Non Hodgkin Lymphoma (NHL).
Study Start Date : April 2009
Actual Primary Completion Date : December 2010
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Lenalidomide and Rituximab
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
Lenalidomide 20 mg p.o. once daily, days 1-21 every 28 days, for 6 cycles
Other Name: Revlimid

Drug: Rituximab
Rituximab 375 mg/m2 intravenously, day 14 of every course for 6 cycles
Other Name: Mabthera

Primary Outcome Measures :
  1. Assess the efficacy [ Time Frame: Two weeks after the completion of Rituximab + Lenalidomide ]
    Evaluate the efficacy in term of Overall Response Rate (Complete Response + Partial Response) and Tumour Control Rate (Complete Response + Partial Response + Stable Disease)

Secondary Outcome Measures :
  1. Assess the safety [ Time Frame: From start of treatment for all follow up period (18 months) ]
    The safety will be evaluated on the basis of recorded toxicities graded on a scale of 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • HIV and Hepatitis B virus (HBV) positivity
  • Hepatitis C virus (HCV) positivity in presence of high level of virus replication and Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) > x 2.5 ULN
  • Central nervous system (CNS) involvement by lymphoma
  • Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
  • Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01830478

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Centro Oncologico Modenese
Modena, MO, Italy, 41124
Sponsors and Collaborators
Gruppo Italiano Studio Linfomi
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Principal Investigator: Stefano Sacchi, MD Gruppo Italiano Studi Linfomi
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Responsible Party: Gruppo Italiano Studio Linfomi Identifier: NCT01830478    
Other Study ID Numbers: INFL08
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors