Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children
NCT ID: NCT01385891
Last Updated: 2011-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2008-08-31
2010-02-28
Brief Summary
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Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet recovery (CRp) and toxicity
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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children with advanced leukemia
Clofarabine VP 16 ciclophospahamide
Clofarabine intravenously 2-hour infusion,dose 40 mg/m2, followed by Etoposide (VP 16)100 mg/m2 i.v. over 2 hours and Cyclophosphamide 440 mg/m2 i.v. over 1 hour
Interventions
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Clofarabine VP 16 ciclophospahamide
Clofarabine intravenously 2-hour infusion,dose 40 mg/m2, followed by Etoposide (VP 16)100 mg/m2 i.v. over 2 hours and Cyclophosphamide 440 mg/m2 i.v. over 1 hour
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
1 Month
20 Years
ALL
No
Sponsors
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Istituto Giannina Gaslini
OTHER
Responsible Party
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G Gaslini Hospital
Principal Investigators
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Concetta Micalizzi, MD
Role: PRINCIPAL_INVESTIGATOR
G. Gaslini Hospital
Locations
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G.Gaslini Children's Hospital
Genova, , Italy
Countries
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Other Identifiers
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2008-004487-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CM001
Identifier Type: -
Identifier Source: org_study_id
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