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

July 6, 2011 updated by: Istituto Giannina Gaslini

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: after an expected average of 3 weeks after the first dose of each chemotherapy course
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
Time Frame: at an expected average of 4 weeks after the first dose of each chemotherapy course
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

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Giannina Gaslini

Investigators

  • Principal Investigator: Concetta Micalizzi, MD, G. Gaslini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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