Back to resultsClove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children (CLOVE)
Primary Purpose
Acute Leukemia
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Clofarabine VP 16 ciclophospahamide
Sponsored by
About this trial
This is an interventional treatment trial for Acute Leukemia
Eligibility Criteria
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
Sites / Locations
- G.Gaslini Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
children with advanced leukemia
Arm Description
Outcomes
Primary Outcome Measures
response to treatment
Secondary Outcome Measures
Number of patients with toxicity as a measure of safety and tolerability
Grade of toxicity defined according to the National Cancer's Inst. Common terminology Criteria (NCI CTCAE v3.0)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01385891
Brief Title
Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children
Acronym
CLOVE
Official Title
Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Istituto Giannina Gaslini
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
children with advanced leukemia
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Clofarabine VP 16 ciclophospahamide
Other Intervention Name(s)
Evoltra, Etoposide, Endoxan
Intervention Description
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
Primary Outcome Measure Information:
Title
response to treatment
Time Frame
after an expected average of 3 weeks after the first dose of each chemotherapy course
Secondary Outcome Measure Information:
Title
Number of patients with toxicity as a measure of safety and tolerability
Description
Grade of toxicity defined according to the National Cancer's Inst. Common terminology Criteria (NCI CTCAE v3.0)
Time Frame
at an expected average of 4 weeks after the first dose of each chemotherapy course
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Concetta Micalizzi, MD
Organizational Affiliation
G. Gaslini Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
G.Gaslini Children's Hospital
City
Genova
ZIP/Postal Code
16147
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children
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