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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia
Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia
For Condition: L2 childhood acute lymphoblastic leukemia,L1 childhood acute lymphoblastic leukemia,recurrent childhood acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): EORTC Children's Leukemia Cooperative Group ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /17 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AntoineThyss, Study Chair, EORTC Children's Leukemia Cooperative Group
Centre Hospitalier Regional de Lille
Lille, , 59037
France
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels (Bruxelles), , 1090
Belgium
CHR Hotel Dieu
Nantes, , 44093
France
Centre Hospitalier Regional de la Citadelle
Liege (Luik), , 4000
Belgium
Hospital Escolar San Joao
Porto, , 4200
Portugal
Universitair Ziekenhuis Gent
Ghent (Gent), , B-9000
Belgium
CHR de Grenoble - La Tronche
Grenoble, , 38043
France
Clinique de l'Esperance
Montegnee, , 4420
Belgium
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
Centre Hospitalier Regional et Universitaire d'Angers
Angers, , 49033
France
Hopital Jean Bernard
Poitiers, , 86021
France
Hopital des Enfants (Purpan Enfants)
Toulouse, , 31026
France
Centre Antoine Lacassagne
Nice, , 06189
France
Hopital Arnaud de Villeneuve
Montpellier, , 34295
France
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Hopital Americain
Reims, , 51092
France
CHU de Caen
Caen, , 14033
France
Hopital Universitaire Des Enfants Reine Fabiola
Brussels (Bruxelles), , 1020
Belgium
Hopital Universitaire Hautepierre
Strasbourg, , 67098
France
Hopital Robert Debre
Paris, , 75019
France
Institut Curie - Section Medicale
Paris, , 75248
France
Hopital Debrousse
Lyon, , 69322
France
CHR de Besancon - Hopital Saint-Jacques
Besancon, , 25030
France
Additional Information:
Study ID Numbers: CDR0000066841; EORTC-58953
Study Start Date: December 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003729
Other L2 Childhood Acute Lymphoblastic Leukemia Studies:
1. Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia
2. Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia
3. Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia
4. Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia
5. Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
Related Studies:
Other L2 childhood acute lymphoblastic leukemia Clinical Trials
Other Clinical Trials
Other Montegnee Clinical Trials
Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia
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