Trial purpose
Cancer treatment
Tumor type
Haematological
Age
65 - 75
Clinical summary
Summary
This is a study investigating the tolerance of oral fludarabine, oral cyclophosphamide and i.v. rituximab (poFCivR) in previously untreated elderly (? 65 years old) patients with chronic lymphocytic leukaemia. Patients will be randomly assigned to one of three treatment groups: fludarabine and rituximab alone or fludarabine and rituximab with either 3 or 5 days of oral cyclophosphamide. The primary endpoint will be the proportion of patients completing 6 treatment cycles.
Conditions
This trial is treating people with Chronic Lymphocytic Leukaemia
Eligibility
Inclusion
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.
Exclusion
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.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Australasian Leukaemia and Lymphoma Group (ALLG)
Scientific Title
An Australasian, phase II, multicentre, randomised, dose intensification study investigating oral fludarabine, oral cyclophosphamide and i.v. rituximab (poFCivR) tolerance in previously untreated elderly (= 65 years old) patients with chronic lymphocytic leukaemia (CLL) (Other IDs: ALLG CLL5).
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