EUCTR2008-000044-14-ITActive, not recruitingNot Applicable
SALVAGE TREATMENT WITH LENALIDOMIDE AND DEXAMETHASONE (LEN-DEX) IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA (MCL) - ND
IIL INTERGRUPPO ITALIANO LINFOMI ONLUS0 sitesStarted: November 7, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Diagnosis of MCL;voluntarily sign an informed consent form; Able to adhere to the study ;  Age>18;Patients treated with at least one prior treatment regimen, not eligible for or relapsed after more intensive treatments (stem cell transplant); Patients with refractory or relapsed disease; Measurable and/or valuable disease;Adequate haematological counts: ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement by MCL; Conjugated bilirubin up to 2 x ULN unless due to liver involvement by MCL;  Alkaline phosphatase and transaminases up to 2 x ULN unless due to liver involvement by MCL;  Creatinine clearance ≥ 50 ml/min; HIV negativity;HCV negativity; HBV negativity or patients with HBcAb +, HbsAg -, HBs Ab+/- and anti HBV prophylaxis with lamivudine;  Non peripheral neuropathy or CNS disease;  Life expectancy > 6 months;  Performance status < 2 according to ECOG scale; Disease free of prior malignancies (a part MCL) with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ?in situ? of the cervix or breast;Written informed consent;Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study Before starting study drug: Female Subjects:oFCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. o Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure.oMust agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from the study. Male Subjects:o Must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy. oWill be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure. Must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from the study. During study participation and for 28 days following discontinuation from the study: Female Subjects: oFCBP with regular cycles oIn addition to the required pregnancy testing;oCounseling about pregnancy precautions and the potential risks of fetal exposure must be conducted at a minimum of every 28 days.o Pregnancy testing and counseling must be performed if a subject misses her period or if her pregnancy test or her menstrual bleeding is abnormal. Male Subjects: Counseling about the requirement for latex condom use during sexual contact with females of childbearing potential and the potential risks of fetal exposure must be conducted at a minimum of every 28 days.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this ag
Exclusion Criteria
- • 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 non-treatment studies is allowed, if it will not interfere with participation in this study;  CNS disease (meningeal and/or brain involvement by lymphoma);  TVP in the last year;  History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances;  Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug);  Creatinine clearances < 50 ml/min;  HIV positivity;  HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- in anti HBV prophilaxis with lamivudine;  Pregnant or lactating women;  Hypersensitivity reactions to previous thalidomide (if any);  Prior rash ≥ 3 while taking thalidomide (if any);  Active opportunistic infection;  Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent;
Investigators
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