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Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children


Phase 2
N/A
17 Years
Not Enrolling
Both
Leukemia

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Trial Information

Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Antoine Thyss, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Antoine Lacassagne

Authority:

United States: Federal Government

Study ID:

EORTC-58953

NCT ID:

NCT00003729

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • L1 childhood acute lymphoblastic leukemia
  • L2 childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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