Combination Chemotherapy With or Without Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia
A Randomized Phase II Trial of Fludarabine, Cyclophosphamide and Mitoxantrone (FCM) With or Without Rituximab in Previously Treated Chronic Lymphocytic Leukemia
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 them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with rituximab may kill more cancer cells. It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase II trial is studying how well giving combination chemotherapy with or without rituximab works in treating patients with previously treated chronic lymphocytic leukemia.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Assess the efficacy and safety of fludarabine, cyclophosphamide, and mitoxantrone hydrochloride with or without rituximab in patients with previously treated chronic lymphocytic leukemia.
- Determine the overall response rate, defined as complete or partial remission, in these patients.
Secondary
- Determine the proportion of patients with undetectable minimal residual disease.
- Determine the 2-year progression-free survival of these patients.
- Determine the 2-year overall survival of these patients.
- Determine the toxicity of this regimen.
OUTLINE: This is a randomized, controlled, open-label, parallel group, multicenter study. Patients are stratified according to prior treatment with fludarabine (refractory vs not refractory or naive). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral fludarabine* and oral cyclophosphamide* on days 1-5 and mitoxantrone hydrochloride IV on day 1.
- Arm II: Patients receive fludarabine*, cyclophosphamide*, and mitoxantrone hydrochloride as in arm I. Patients also receive rituximab IV on day 1.
NOTE: *If the oral regimen is not tolerated, patients may receive fludarabine IV and cyclophosphamide IV on days 1-3.
Treatment in both arms repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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England
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Birmingham, England, 영국, B9 5SS
- Birmingham Heartlands Hospital
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Blackpool, England, 영국, FY3 8NR
- Blackpool Victoria Hospital
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Canterbury, England, 영국, CT2 7NR
- Kent and Canterbury Hospital
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Carshalton, England, 영국, SM5 1AA
- St Helier Hospital
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Dartford Kent, England, 영국, DA2 8DA
- Darent Valley Hospital
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Gillingham Kent, England, 영국, ME7 5NY
- Medway Maritime Hospital
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Leeds, England, 영국, LS1 3EX
- Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
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Leicester, England, 영국, LE1 5WW
- Leicester Royal Infirmary
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Liverpool, England, 영국, L7 8XP
- Royal Liverpool and Broadgreen Hospitals NHS Trust
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Maidstone, England, 영국, ME16 9QQ
- Maidstone Hospital
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Manchester, England, 영국, M20 4BX
- Christie Hospital Nhs Trust
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Truro, Cornwall, England, 영국, TR1 3LJ
- Royal Cornwall Hospital
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Tunbridge Wells, Kent, England, 영국, TN4 8AT
- Kent and Sussex Hospital
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Wishaw, England, 영국, ML2 0DP
- Wishaw General Hospital
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Scotland
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Airdrie, Scotland, 영국, ML6 0JF
- Monklands General Hospital
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Wales
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Cardiff, Wales, 영국, CF14 4XW
- University Hospital of Wales
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Overall response rate as measured by NCI Response Criteria
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2차 결과 측정
결과 측정 |
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독성
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2년 전체 생존
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2년 무진행 생존
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Proportion of patients with undetectable minimal residual disease
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공동 작업자 및 조사자
수사관
- 연구 의자: Peter Hillmen, MD, Leeds General Infirmary
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CTRU-NCRI-UKCLL01-FCM/FCM-R
- CDR0000485181 (레지스트리 식별자: PDQ (Physician Data Query))
- EU-20626
- ROCHE-NCRI-UKCLL01-FCM/FCM-R
- ISRCTN77546448
- EUDRACT-2004-003982-34
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