Status:
COMPLETED
CLL-Irl Study. CTRIAL-IE (ICORG) 07-01, V7
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Leukemia
Eligibility:
All Genders
Up to 64 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividin...
Detailed Description
OBJECTIVES: Primary * Evaluate the efficacy, in terms of complete remission rate, of fludarabine phosphate, cyclophosphamide, and rituximab in patients with chronic lymphocytic leukemia. Secondary ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia
- Stage I-IV disease (Binet stage progressive A, B, C)
- CD5 and CD23 positive
- Untreated OR relapsed/resistant disease after combination chemotherapy or rituximab
- No 17p deletion
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy \> 1 year
- Creatinine clearance ≥ 50 mL/min
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other concurrent malignancy except for noninvasive cervical cancer or localized nonmelanomatous skin cancer
- No history of anaphylaxis to mouse-derived humanized monoclonal antibody
- No other severe concurrent (e.g., cardiac or pulmonary) diseases or mental disorders that could interfere with ability to participate in the study
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
August 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00812669
Start Date
August 18 2008
End Date
November 21 2019
Last Update
July 8 2025
Active Locations (7)
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1
Tallaght University Hospital
Dublin, Leinster, Ireland
2
Cork University Hospital
Cork, Munster, Ireland
3
St. James's Hospital
Dublin, Ireland, 8
4
University College Hospital
Galway, Ireland