An Australian, phase II , multicentre, randomised, open-label, dose intensification study of three patient cohorts, investigating varying dose schedules, each of 6 x 28day cycles, with monitoring continuing for 12 months into the post treatment period.
- Conditions
- Chronic Lymphocytic Leukaemia (CLL)Cancer - Leukaemia - Chronic leukaemia
- Registration Number
- ACTRN12608000404325
- Lead Sponsor
- Australasian Leukaemia and Lymphoma Group
- Brief Summary
The diagnosis and treatment of CLL may have a great impact on the quality of life (QoL) due to a variety of reasons including disease-related symptoms, infection, effects of therapy and the emotional, socio-economic, and functional effects of living with an 'incurable' illness. The main aim of any treatment is to maximize QoL by inducing remission with minimal short- and long-term toxicity. Balancing disease and symptom control with QoL in elderly patients receiving CLL therapy regimens can be challenging. There is little published QoL data in elderly CLL patients receiving the FCR (fludarabine, cyclophosphamide, rituximab) immunochemotherapy regimen. Our prior study showed no significant difference in health related QoL for first-line therapy of CLL with monotherapy between chlorambucil, fludarabine and cladribine (Mulligan, SP et al. Leuk Lymphoma, 2014).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1. B-CLL confirmed according to National Cancer Institute (NCI) Working Group Criteria.
2. Binet stage B or C, or progressive symptomatic stage A (see Protocol Appendix I).
3. Age = 65 years old.
4. Judged to be in need of systemic therapy (see Protocol Appendix II).
5. No previous treatment (chemotherapy, radiotherapy or immunotherapy) for CLL.
6. Alkaline phosphatase and transaminases = 2 x ULN.(Upper Limits of Normal)
7. Creatinine clearance = 50 ml/min (as calculated by (estimated Glomerular Filtration Rate) eGFR; eGFR also calculated by
Cockcroft and Gault formula for final analysis; see Protocol Appendix III).
8. Females of childbearing potential or fertile males must take contraceptive measures during
and at least 6 months after cessation of therapy.
9. (Eastern Cooperative Group) ECOG performance status 0-1.
10. Cumulative Illnes Rating Scale CIRS score < 6 (see Protocol Appendix IV).
11. Life expectancy > 6 months.
12. Patient’s written informed consent.
1. Age < 65 years old.
2. Non-progressive or stable Binet stage A.
3. Clinically significant auto-immune cytopenia, Coombs-positive haemolytic anaemia (as
discerned by treating physician).
4. Active second malignancy currently requiring treatment (except for non-melanoma skin
cancer or cervical cancer in situ or tumour treated curatively by surgery > 5 years ago)
5. Concomitant disease requiring prolonged use of glucocorticoids (> 1 month).
6. Known hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or
any of the study drugs.
7. ECOG performance status 2-3.
8. Class III or IV cardiac disease defined by the NYHA.
9. Severe or debilitating pulmonary disease.
10. Severe or debilitating central nervous system disease or cerebral dysfunction.
11. Transformation to aggressive B-cell malignancy, e.g. diffuse large cell lymphoma, Richter’s
syndrome or prolymphocytic leukaemia.
12. Active bacterial, viral or fungal infection; patients who have known Human Immunodeficiency
Virus (HIV) infection or active hepatitis B virus (HBV) or hepatitis C virus
(HCV) infection.
13. Total bilirubin > 2 x ULN.
14. Creatinine clearance < 50 ml/min (as calculated by eGFR).
15. Any coexisting medical or psychological condition that would preclude participation in the
required study procedures.
16. Treatment with any other investigational agent, or participation in another clinical trial
within 30 days prior to entering this study.
17. Pregnancy and lactation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method