RIAltO: A Randomised Investigation of Alternative Ofatumumabcontaining regimens in less fit patients with CLL
- CLL requiring treatment by NCI/IWCLL 2008 criteria. At least one of the following criteria:
- Progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia.
- Massive (i.e. 6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
- Massive (i.e. 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
- Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months.
- No prior therapy for CLL
- Full-dose R-FC considered inappropriate for at least one of the following reasons
- Age 75 or greater
- WHO performance status 2 or 3
- Cardiac impairment (NYHA class II)
- Respiratory impairment (bronchiectasis or moderate COPD)
- Renal impairment (estimated Glomerular Filtration Rate (eGFR) 10-30 ml/min)
- Any other significant co-morbidity or factor that makes R-FC inappropriate
- Considered able to tolerate Chl at the dose used in the LRF CLL4 trial (10mg/m2 d1-7)
- Written informed consent
- Neutrophil count less than 1.0 x 109/l or platelet count less than 50 x 109/l unless due to CLL*
- Uncontrolled auto-immune haemolytic anaemia or thrombocytopenia
- Active infection
- Seropositivity for HIV, HCV or HBV (surface antigen or core antibody)
- Severe renal impairment (eGFR less than 10ml/min)
- Severe hepatic impairment (serum bilirubin more than twice the upper limit of normal) unless due to CLL or Gilbert’s syndrome.
- Concurrent treatment with glucocorticoids equivalent to more than prednisolone 20mg od
- Prior treatment with monoclonal antibody therapy within the last 3 months.
- Yellow fever vaccination within 4 weeks prior to treatment start
- Known hypersensitivity to ofatumumab, bendamustine or chlorambucil or any of their excipients
- CNS involvement with CLL
- History of Richter transformation
- Concomitant malignancies within the last 3 years except successfully treated non-melanoma skin cancer or carcinoma in situ.
- Major surgery within 28 days prior to randomisation
- WHO performance status 4
- Severe cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), and arrhythmia (excluding extra systoles or minor conduction abnormalities) unless controlled by therapy.
- Any serious underlying medical or psychological conditions, which could impair the ability of the patient to participate in the trial or compromise ability to give informed consent
- Treatment within a clinical trial within 30 days prior to trial entry.
- Adult patient under tutelage (not competent to sign informed consent).
- Pregnant or lactating women.
Tel: 0113 2068513
Tel: 0113 2067436
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Other trials currently active for Chronic Lymphocytic Leukaemia
A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletion
A Phase II Trial of Ofatumumab, Dexamethasone and Lenalidomide Followed by Randomisation to Lenalidomide Maintenance Versus No Further Treatment for High-Risk CLL.
CLL Lenalidomide Maintanence 002 – The Continuum Trial
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) AS MAINTENANCE THERAPY FOR PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA FOLLOWING SECOND-LINE THERAPY (The Continuum Trial)