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Trial record 6 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01385891
Recruitment Status : Completed
First Posted : June 30, 2011
Last Update Posted : July 8, 2011
Information provided by:
Istituto Giannina Gaslini

Brief 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

Condition or disease Intervention/treatment Phase
Acute Leukemia Drug: Clofarabine VP 16 ciclophospahamide Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients
Study Start Date : August 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

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:
  • Evoltra
  • Etoposide
  • Endoxan

Primary Outcome Measures :
  1. response to treatment [ Time Frame: after an expected average of 3 weeks after the first dose of each chemotherapy course ]

Secondary Outcome Measures :
  1. 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)

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Ages Eligible for Study:   1 Month to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01385891

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

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Responsible Party: lorenzo moretta, G Gaslini Hospital Identifier: NCT01385891     History of Changes
Other Study ID Numbers: CM001
2008-004487-39 ( EudraCT Number )
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: July 8, 2011
Last Verified: July 2008
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Acute Disease
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action