Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia
Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have relapsed or refractory acute lymphocytic leukemia.
연구 개요
상세 설명
OBJECTIVES: I. Evaluate the complete response rate to combination fludarabine, idarubicin, and cytarabine in children with relapsed or refractory acute lymphocytic leukemia. II. Evaluate the safety and tolerance of this treatment in these patients. III. Evaluate the time to progression, disease free survival, and overall survival of these patients.
OUTLINE: This is an open label, multicenter study. Patients receive idarubicin IV over 1 hour on days 1-3. Fludarabine IV is administered over 30 minutes on days 1-5. Cytarabine IV is administered over 4 hours on days 1-5. If partial response is obtained, patients receive a second course of treatment. Patients receive a consolidation course in the absence of disease progression and unacceptable toxicity. Idarubicin IV is administered over 1 hour on days 1 and 2. Fludarabine IV is administered over 30 minutes, followed by cytarabine IV over 4 hours on days 1-5. Patients are followed every 3 months for 2 years or until death.
PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 27 months.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Antwerp, 벨기에, 2020
- Algemeen Ziekenhuis Middelheim
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Brussels (Bruxelles), 벨기에, 1090
- Academisch Ziekenhuis der Vrije Universiteit Brussel
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Brussels (Bruxelles), 벨기에, 1020
- Hôpital Universitaire Des Enfants Reine Fabiola
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Ghent (Gent), 벨기에, B-9000
- Universitair Ziekenhuis Gent
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Leuven, 벨기에, B-3000
- U.Z. Gasthuisberg
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Liege (Luik), 벨기에, 4000
- Centre Hospitalier Régional de la Citadelle
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Montegnee, 벨기에, 4420
- Clinique de l'Esperance
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Porto, 포르투갈, 4200
- Hospital Escolar San Joao
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Angers, 프랑스, 49033
- Centre Hospitalier Regional et Universitaire d'Angers
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Besancon, 프랑스, 25030
- CHR de Besancon - Hopital Saint-Jacques
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Caen, 프랑스, 14033
- CHU de Caen
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Grenoble, 프랑스, 38043
- Chr De Grenoble - La Tronche
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Lille, 프랑스, 59037
- Centre Hospitalier Regional de Lille
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Lyon, 프랑스, 69322
- Hopital Debrousse
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Montpellier, 프랑스, 34295
- Hopital Arnaud de Villeneuve
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Nantes, 프랑스, 44093
- CHR Hotel Dieu
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Nice, 프랑스, 06189
- Centre Antoine Lacassagne
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Paris, 프랑스, 75019
- Hopital Robert Debre
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Paris, 프랑스, 75248
- Institut Curie - Section Medicale
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Poitiers, 프랑스, 86021
- Hopital Jean Bernard
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Reims, 프랑스, 51092
- Hopital Americain
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Strasbourg, 프랑스, 67098
- Hopital Universitaire Hautepierre
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Toulouse, 프랑스, 31026
- Hopital des Enfants (Purpan Enfants)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS: Cytologically diagnosed relapsed or refractory acute lymphocytic leukemia previously treated with front line therapy FAB L1 or L2 Bone marrow relapse either isolated or associated with CNS or testicular relapse Bone marrow blast cells greater than 10% No isolated CNS relapse
PATIENT CHARACTERISTICS: Age: Under 18 Performance status: WHO 0-2 Play-performance scale at least 60% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.5 times normal Renal: Creatinine less than 2.5 times normal Cardiovascular: No symptoms of cardiac failure No decline of ejection fraction by more than 20% of the lower limit of normal Shortening fraction at least 25% Other: No psychological, familial, sociological or geographical condition that would hamper compliance No uncontrolled infection
PRIOR CONCURRENT THERAPY: At least 6 months since prior autologous bone marrow transplantation No prior allogeneic bone marrow transplantation No concurrent treatment with other experimental drug
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
수사관
- 연구 의자: Antoine Thyss, MD, Centre Antoine Lacassagne
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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
- EORTC-58953
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