A randomised, phase IIB trial in previously untreated patients with chronic lymphocytic leukaemia (CLL) to compare fludarabine, cyclophosphamide and rituximab (FCR) with FC, mitoxantrone and low dose rituximab (FCM-miniR)

eeds Teaching Hospitals NHS Trust (UK)0 个研究点目标入组 206 人开始时间: 2008年9月25日最近更新: 2022年4月4日

适应症

试验速览

•1. Both males and females, at least 18 years old
•2. B-CLL with a characteristic immunophenotype
•3. Binet's Stages B, C or Progressive Stage A
•4. Requiring therapy by the International Workshop on CLL (IWCLL) criteria in that they must have at least one of the following: Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia
•5. Massive (i.e. 6 cm below the left costal margin) or progressive or symptomatic splenomegaly
•6. Massive nodes (i.e. 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
•7. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months as long as the lymphocyte count is over 30 x 10^9/L
•8. A minimum of any one of the following disease-related symptoms must be present:
•8.1. Unintentional weight loss more than or equal to 10% within the previous 6 months
•8.2. Significant fatigue (i.e. Eastern Cooperative Oncology Group PS 2 or worse; cannot work or unable to perform usual activities)
•8.3. Fevers of greater than 38.0°C for 2 or more weeks without other evidence of infection
•8.4. Night sweats for more than 1 month without evidence of infection
•9. No prior therapy for CLL
•10. World Health Organization (WHO) performance status (PS) of 0, 1 or 2
•11. Able to provide written informed consent

•1. Prior therapy for CLL
•2. Active infection
•3. Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanised monoclonal antibodies
•4. Pregnancy, lactation or women of child-bearing potential unwilling to use medically approved contraception whilst receiving treatment
•5. Men whose partners are capable of having children but who are not willing to use appropriate medically approved contraception during the study, unless they are surgically sterile
•6. Central nervous system (CNS) involvement with CLL
•7. Mantle cell lymphoma
•8. Other severe, concurrent diseases or mental disorders
•9. Known HIV positive
•10. Patient has active or prior hepatitis B or C
•11. Active secondary malignancy excluding basal cell carcinoma
•12. Persisting severe pancytopenia (neutrophils <0.5 x 10^9/l or platelets <50 x 10^9/l) or transfusion dependent anaemia unless due to direct marrow infiltration by CLL
•13. Active haemolysis (patients with haemolysis controlled with prednisolone at a dose 10 mg or less per day can be entered into the trial)
•14. Patients with a creatinine clearance of less than 30 ml/min (either measured or derived by the Cockcroft formula)

发起方

eeds Teaching Hospitals NHS Trust (UK)