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Lenalidomide Plus Rituximab (R) in Non Follicular NHL

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Studio Linfomi

Tracking Information
First Submitted Date  ICMJE April 5, 2013
First Posted Date  ICMJE April 12, 2013
Last Update Posted Date April 12, 2013
Study Start Date  ICMJE April 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2013)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lenalidomide Plus Rituximab (R) in Non Follicular NHL
Official Title  ICMJE Phase II Study of Lenalidomide in Combination With Rituximab (R) for the Treatment of Indolent Non Follicular Non Hodgkin Lymphoma (NHL).
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Indolent Non Hodgkin Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Lenalidomide
  • Drug: Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 9, 2013)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2014
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01830478
Other Study ID Numbers  ICMJE INFL08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gruppo Italiano Studio Linfomi
Study Sponsor  ICMJE Gruppo Italiano Studio Linfomi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefano Sacchi, MD Gruppo Italiano Studi Linfomi
PRS Account Gruppo Italiano Studio Linfomi
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP