- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01830478
Lenalidomide Plus Rituximab (R) in Non Follicular NHL
April 9, 2013 updated by: Gruppo Italiano Studio Linfomi
Phase II Study of Lenalidomide in Combination With Rituximab (R) for the Treatment of Indolent Non Follicular Non Hodgkin Lymphoma (NHL).
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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patients will be evaluated for tumor response (complete assessment); the patients with Progressive Disease (PD) will be withdrawn of the study.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and Partial Response (PR), and with a stable disease will undergo the follow up phase, while patients with PD will be withdrawn of the study.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
Interventional
Enrollment (Anticipated)
44
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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MO
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Modena, MO, Italy, 41124
- Centro Oncologico Modenese
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Lenalidomide 20 mg p.o. once daily, days 1-21 every 28 days, for 6 cycles
Other Names:
Rituximab 375 mg/m2 intravenously, day 14 of every course for 6 cycles
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the efficacy
Time Frame: Two weeks after the completion of Rituximab + Lenalidomide
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Evaluate the efficacy in term of Overall Response Rate (Complete Response + Partial Response) and Tumour Control Rate (Complete Response + Partial Response + Stable Disease)
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Two weeks after the completion of Rituximab + Lenalidomide
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the safety
Time Frame: From start of treatment for all follow up period (18 months)
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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
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From start of treatment for all follow up period (18 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stefano Sacchi, MD, Gruppo Italiano Studi Linfomi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Anticipated)
October 1, 2014
Study Registration Dates
First Submitted
April 5, 2013
First Submitted That Met QC Criteria
April 9, 2013
First Posted (Estimate)
April 12, 2013
Study Record Updates
Last Update Posted (Estimate)
April 12, 2013
Last Update Submitted That Met QC Criteria
April 9, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
- Rituximab
Other Study ID Numbers
- INFL08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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