Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children (CLOVE)

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

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

Study Overview

• Status: Completed
• Conditions: Acute Leukemia
• Intervention / Treatment: Drug: Clofarabine VP 16 ciclophospahamide

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Italy
  • Genova, Italy, 16147
    • G.Gaslini Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: children with advanced leukemia	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; Other Names: Endoxan; Evoltra; Etoposide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
response to treatment	after an expected average of 3 weeks after the first dose of each chemotherapy course

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Giannina Gaslini
• Investigators: Principal Investigator: Concetta Micalizzi, MD, G. Gaslini Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: June 21, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Estimate): July 8, 2011
• Last Update Submitted That Met QC Criteria: July 6, 2011
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Leukemia; Acute Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide; Clofarabine
• Other Study ID Numbers: CM001; 2008-004487-39 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No