The research project is trying to find out if we can improve the results of best available chemotherapy for Chronic Lymphocytic Leukaemia (CLL) by the addition of a new drug called lenalidomide.
An Australasian and French Phase III, Multicentre, Randomised Trial Comparing Lenalidomide Consolidation versus No Consolidation in Patients With Chronic Lymphocytic Leukaemia and Residual Disease Following Induction Chemotherapy
Australasian Leukaemia and Lymphoma Group (ALLG)
192 participants
May 27, 2011
Interventional
Conditions
Summary
to assess the effect of lenalidomide consolidation (vs observation with no further therapy) in previously untreated CLL patients with measurable disease after at least 4 cycles of FCR therapy.
Eligibility
Inclusion Criteria4
- B-cell Chronic Lymphocytic Leukaemia (CLL) confirmed according to World Health Organisation (WHO) Criteria. Age 18 years or older. Pre-Fludarabine chlorambucil (FC)/Fludarabine chlorambucil rituximab (FCR) chemotherapy blood sample desirable. Completed 4 to 6 cycles of FC or FCR, and within 3 – 6 months of last dose of chemotherapy. Achieved partial response or better following chemotherapy. Evidence of residual disease: at least one of clinical or CT lymphadenopathy >1.5cm, clinical or Computed Axial Tomography Scan (CT) hepatomegaly or splenomegaly, positive bone marrow histology (including the persistence of three or
- more lymphoid nodules, regardless of immunohistochemical features), or detectable minimal residual disease (MRD) in blood or
- marrow obtained from flow cytometry result performed at Westmead Hospital Flow Cytometry Unit. Adequate haematological recovery following chemotherapy (haemoglobin (Hb) > 110g/L, neutrophils > 1.5 x 10^9/L,
- platelets >100 x 10^9/L). Alkaline phosphatase and transaminases lessthan or equal to 2 x Upper Limit of Normal (ULN). Creatinine clearance greaterthan or equal to 30 ml/min at Screening (calculated by Cockcroft-Gault formula. Females of childbearing potential must use an effective method of contraception or practice absolute abstinence for 4 weeks prior to lenalidomide therapy, during treatment and 4 weeks after treatment discontinuation Male patients must use contraception during lenalidomide treatment and for 1 week after Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. Life expectancy greater than 6 months. Patient’s written informed consent. Subjects must agree not to donate blood, semen or sperm while on study treatment and for 1 week after treatment discontinuation. Subjects must agree not to share their medication and to return unused supplies.
Exclusion Criteria2
- Prior chemotherapy other than any of the following:
- a) chlorambucil given for CLL up to a cumulative dose 70mg/m2 b) FC and FCR induction chemotherapy. Active second malignancy currently requiring treatment (except for non-melanoma skin cancer or cervical cancer in-situ). Known hypersensitivity with anaphylactic reaction to lenalidomide. Class III or IV cardiac disease defined by the New York Heart Association (NYHA). Severe or debilitating pulmonary disease. Severe or debilitating central nervous system disease or cerebral dysfunction. Transformation to aggressive B-cell malignancy, e.g. diffuse large cell lymphoma, Richter’s syndrome or prolymphocytic leukaemia. Active bacterial, viral or fungal infection at Screening. Human Immuno-deficiency Virus (HIV) infection. Positivity for Hepatitis B Virus (HBV) surface antigen or HBV surface antibody unless due to vaccination. Any coexisting medical or psychological condition that would preclude participation in the required study procedures. Pregnancy and lactation. Vaccination with a ‘live’ vaccine at any time during the study Trial participant not accessible for duration of trial including follow up.
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Interventions
After initial chemotherapy (the standard routine chemotherapy given to patients with CLL) patients will be randomised to either follow-up or to new medication Lenalidomide. Patients randomised to followup will visit their clinician regularly and have blood tests for the same amount of time as those randomised to Lenalidomide. Those randomised to Lenalidomide will commence at 5mg (2.5 mg for those with renal impairment) and, if tolerated, escalate to a maximum of 10mg (5mg in renally impaired) in 2.5mg increments every 2 cycles. At day 28 patient will undergo blood tests to ensure safe to continue with treatment. A new cycle will commence at the appropriate dose. This will occur for 24 months (2years).
Locations(1)
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ACTRN12610000060044