ISRCTN51382468CompletedPhase 2
Combination fludarabine and cyclophosphamide (FC) plus Ofatumumab at Standard or Mega dose In Chronic lymphoid leukemia (CLL): a phase II, multi-centre, randomised, open, parallel group trial
eeds Teaching Hospitals NHS Trust (UK)0 sites62 target enrollmentStarted: September 21, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 62
Study Overview
Brief Summary
2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27645620 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34028800/ (added 04/06/2021)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. At least 18 years old
- •2. Chronic lymphocytic leukaemia requiring therapy
- •3. Previous treatment with at least one chemotherapeutic regime
- •4. Be capable of giving written informed consent
- •5. World Health Organisation (WHO) performance status (PS) of 0, 1, or 2
- •6. Life expectancy of at least 12 weeks
- •7. Considered fit enough to receive fludarabine-based combinations
Exclusion Criteria
- •1. Fludarabine refractory: defined as no response to or relapse within 6 months of fludarabine alone or in combination with cyclophosphamide (FC)
- •2. Relapse within 12 months of FC with rituximab (FCR)
- •3. Deletion of chromosome 17p on fluorescent in-situ hybridisation (FISH) [will be performed in Haematological Malignancy Diagnostic Service (HMDS) at screening]
- •4. Previous treatment with ofatumumab either alone or in combination with chemotherapy
- •5. Toxicity attributable to purine analogues such as autoimmune haemolytic anaemia,
- •neurological toxicity or allergy
- •6. Active infection
- •7. Other severe, concurrent (particularly cardiac or pulmonary) diseases or mental disorders that could interfere with their ability to participate in the study
- •8. Patients with a creatinine clearance of less than 30ml/min (either measured or derived by the Cockcroft-Gault formula)
- •9. Pregnant, lactating or women of child bearing potential unwilling to use medically approved contraception whilst receiving treatment and for 12 months after treatment has finished
- •10. Men whose partners are capable of having children but who are not willing to use
- •appropriate medically approved contraception whilst receiving treatment and for 12 months after treatment has finished, unless they are surgically sterile
- •11. Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per Investigator assessment)
- •12. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrolment, whichever is longer, or currently participating in any other interventional clinical study
- •13. Other past or current malignancy. Subjects who have been free of malignancy for at least 2 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
- •14. Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy
- •15. Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C
- •16. History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
- •17. Known human immunodeficiency (HIV) positive
- •18. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomisation, congestive heart failure New York Heart Association (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
- •19. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the Investigator may represent a risk for the patient.
- •20. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded
- •21. Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to conf
Investigators
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