Status:
COMPLETED
Combination Chemotherapy With or Without Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia
Lead Sponsor:
Cancer Research UK
Conditions:
Leukemia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping th...
Detailed Description
OBJECTIVES: Primary * Assess the efficacy and safety of fludarabine, cyclophosphamide, and mitoxantrone hydrochloride with or without rituximab in patients with previously treated chronic lymphocyti...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia requiring therapy
- Previously treated with ≥ 1 chemotherapeutic regimen
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 12 weeks
- Creatinine clearance ≥ 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use effective contraception for 4 weeks before, during, and for 6 months after completion of study treatment
- Fertile male patients must use effective contraception during and for 6 months after completion of study treatment
- No history of anaphylaxis after exposure to rat or mouse-derived complementary-determining region (CDR)-grafted humanized monoclonal antibodies
- No toxicity attributable to purine analogues (e.g., autoimmune hemolytic anemia, neurological toxicity, or allergy)
- No active infection
- No other severe (particularly cardiac or pulmonary) diseases or mental disorders that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior fludarabine (or other purine analogues) combined with cyclophosphamide and mitoxantrone hydrochloride
- No prior rituximab, either alone or in combination with chemotherapy
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00337246
Start Date
July 1 2005
End Date
March 1 2011
Last Update
August 2 2013
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5SS
2
Blackpool Victoria Hospital
Blackpool, England, United Kingdom, FY3 8NR
3
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT2 7NR
4
St Helier Hospital
Carshalton, England, United Kingdom, SM5 1AA