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

This study has been completed.
Sponsor:
Information provided by:
Istituto Giannina Gaslini
ClinicalTrials.gov Identifier:
NCT01385891
First received: June 21, 2011
Last updated: July 6, 2011
Last verified: July 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Acute Leukemia
 Drug: Clofarabine VP 16 ciclophospahamide
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients

Resource links provided by NLM:

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Further study details as provided by Istituto Giannina Gaslini:

Primary Outcome Measures:
  • response to treatment [ Time Frame: after an expected average of 3 weeks after the first dose of each chemotherapy course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Grade of toxicity defined according to the National Cancer's Inst. Common terminology Criteria (NCI CTCAE v3.0)


Enrollment: 40
Study Start Date: August 2008
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Evoltra
  • Etoposide
  • Endoxan

  Eligibility

Ages Eligible for Study:   1 Month to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385891

Locations
Italy
G.Gaslini Children's Hospital
Genova, Italy, 16147
Sponsors and Collaborators
Istituto Giannina Gaslini
Investigators
Principal Investigator: Concetta Micalizzi, MD G. Gaslini Hospital
  More Information

No publications provided

Responsible Party: lorenzo moretta, G Gaslini Hospital
ClinicalTrials.gov Identifier: NCT01385891     History of Changes
Other Study ID Numbers: CM001, 2008-004487-39
Study First Received: June 21, 2011
Last Updated: July 6, 2011
Health Authority: ITALY: Agenzia Italiana del Farmaco (AIFA)

Additional relevant MeSH terms:
Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Etoposide
 Etoposide phosphate
Clofarabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013