Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients
Phase 2/Phase 3
1 Month
20 Years
1 Month
20 Years
Not Enrolling
Both
Acute Leukemia
Both
Acute Leukemia
Trial Information
Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients
Inclusion Criteria:
- presence of > 25% of blast in bone marrow
- treatment with second line therapies
- patients with resistant disease i.e. with >25% of blasts 21 days after the last
cytostatic agent administration
- children with persistent high MRD level (> 10-3) after first or further line
chemotherapy, were considered eligible to the treatment
- Relapsed after > months after SCT
- Karnofsky score >50
- a Forced Espiratory Volume >30%
- sufficient hepatic and renal function defined as creatinine levels <2 × ULN,
bilirubin <1.5 × ULN
- aspartate and alanine aminotransferases <10 × ULN.
Exclusion Criteria:
- isolated extra-medullary relapse, and active infections
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
response to treatment
Outcome Time Frame:
after an expected average of 3 weeks after the first dose of each chemotherapy course
Safety Issue:
No
Principal Investigator
Concetta Micalizzi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
G. Gaslini Hospital
Authority:
ITALY: Agenzia Italiana del Farmaco (AIFA)
Study ID:
CM001
NCT ID:
NCT01385891
Start Date:
August 2008
Completion Date:
February 2010
Related Keywords:
- Acute Leukemia
- Leukemia
- Acute Disease
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