Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children

Acute Leukemia Clinical Trial

— CLOVE  

Official title:

Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients

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

• Acute Disease
• Acute Leukemia
• Leukemia

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