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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01385891
Other study ID # CM001
Secondary ID 2008-004487-39
Status Completed
Phase Phase 2/Phase 3
First received June 21, 2011
Last updated July 6, 2011
Start date August 2008
Est. completion date February 2010

Study information

Verified date July 2008
Source Istituto Giannina Gaslini
Contact n/a
Is FDA regulated No
Health authority ITALY: Agenzia Italiana del Farmaco (AIFA)
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 20 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Italy G.Gaslini Children's Hospital Genova

Sponsors (1)

Lead Sponsor Collaborator
Istituto Giannina Gaslini

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary response to treatment after an expected average of 3 weeks after the first dose of each chemotherapy course No
Secondary 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) at an expected average of 4 weeks after the first dose of each chemotherapy course Yes
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