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Pilot Study to Establish Safety & Efficacy of a Combination of Dexamethasone and Lenalidomide in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia (CLL)
Bu çalışma, nüks etmiş ya da tedaviye dirençli kronik lenfositik lösemi (chronic lymphocytic leukaemia, CLL) olan hastalarda Lenalidomide ve Dexamethasone kombinasyonunun güvenliliğini ve etkililiğini araştırmıştır. Çalışmaya 18 yaş üstü, daha önce 1-3 basamak tedavi almış hastalar alınmıştır. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Diagnosis of relapsed or refractory CLL as defined by the NCIWG criteria, requiring treatment * 1-3 lines of prior therapy * Fludarabine- or Alemtuzumab-based therapy inappropriate * WHO Performance status ≤2 * Age ≥ 18 years * Life expectancy \> 6 months * Male and female subjects must meet the inclusion criteria for the Lenalidomide Pregnancy Prevention Risk Management Plan. * Male and female subjects must agree to follow the Lenalidomide Pregnancy Prevention Risk Management Plan (including contraception 4 weeks before, during and 4 weeks after treatment for females of child-bearing potential). * Signed informed consent Exclusion Criteria: * Previously untreated CLL * Fit patients for whom alemtuzumab or fludarabine- based therapy would be appropriate * Creatinine clearance \< 30ml/min calculated by Cockcroft-Gault * Bilirubin \> 1.5 x upper limit of normal * Patients with marrow suppression resulting in significant cytopenia (Neutrophils \<0.5 x 109/l, Platelets \<30 x 109/l). * Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy or other investigational therapy within 4 weeks prior to study Day 1. * Known infection with HIV, hepatitis B or hepatitis C. * Uncontrolled glaucoma, diabetes mellitus, hypertension or symptomatic peptic ulcer disease * Peripheral neuropathy \> grade 1 * Proven or suspected transformation to aggressive B-cell malignancy (e.g. large -B-cell lymphoma, Richter's syndrome, or PLL). * Second malignancy requiring treatment other than non metastatic skin or prostate tumours * Any medical condition that would require long-term use (\>1 month) of systemic corticosteroids at a dose greater than 5mg/day of prednisolone during study treatment. * Active uncontrolled bacterial, viral or fungal infections Cardiac failure, myocardial infarction within 6 months prior to study day 1, or evidence of ischaemia on ECG within 30 days prior to study day 1. * Epileptic disorders requiring anticonvulsant therapy * Major surgery, other than diagnostic surgery within 4 weeks prior to Study Day 1. * Pregnant or currently breastfeeding. * Patients who for other reasons are not expected to complete the study * Subjects with a known allergy to allopurinol