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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Antwerp, Belgia, 2020
- Algemeen Ziekenhuis Middelheim
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Brussels (Bruxelles), Belgia, 1090
- Academisch Ziekenhuis der Vrije Universiteit Brussel
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Brussels (Bruxelles), Belgia, 1020
- Hôpital Universitaire Des Enfants Reine Fabiola
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Ghent (Gent), Belgia, B-9000
- Universitair Ziekenhuis Gent
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Leuven, Belgia, B-3000
- U.Z. Gasthuisberg
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Liege (Luik), Belgia, 4000
- Centre Hospitalier Régional de la Citadelle
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Montegnee, Belgia, 4420
- Clinique de l'Esperance
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Angers, Frankrike, 49033
- Centre Hospitalier Regional et Universitaire d'Angers
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Besancon, Frankrike, 25030
- CHR de Besancon - Hopital Saint-Jacques
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Caen, Frankrike, 14033
- CHU de Caen
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Grenoble, Frankrike, 38043
- Chr De Grenoble - La Tronche
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Lille, Frankrike, 59037
- Centre Hospitalier Regional de Lille
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Lyon, Frankrike, 69322
- Hopital Debrousse
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Montpellier, Frankrike, 34295
- Hopital Arnaud de Villeneuve
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Nantes, Frankrike, 44093
- CHR Hotel Dieu
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Nice, Frankrike, 06189
- Centre Antoine Lacassagne
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Paris, Frankrike, 75019
- Hopital Robert Debre
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Paris, Frankrike, 75248
- Institut Curie - Section Medicale
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Poitiers, Frankrike, 86021
- Hopital Jean Bernard
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Reims, Frankrike, 51092
- Hopital Americain
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Strasbourg, Frankrike, 67098
- Hopital Universitaire Hautepierre
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Toulouse, Frankrike, 31026
- Hopital des Enfants (Purpan Enfants)
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Porto, Portugal, 4200
- Hospital Escolar San Joao
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Antoine Thyss, MD, Centre Antoine Lacassagne
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Leukemi
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antibiotika, antineoplastisk
- Fludarabin
- Fludarabinfosfat
- Cytarabin
- Idarubicin
Andre studie-ID-numre
- EORTC-58953
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