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OpenTrials
Completed

NCT Number: NCT01385891

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

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

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Key information

Conditions

Acute Leukemia

Age range

1 month–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

G.Gaslini Children's Hospital

Genova, 16147, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clofarabine VP 16 ciclophospahamide

Drug

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 outcomes

  1. response to treatment

    Time frame: after an expected average of 3 weeks after the first dose of each chemotherapy course

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Istituto Giannina Gaslini

Other

Registry information

Official study title

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

Acronym: CLOVE

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jun 30, 2011
Registry last updated
Jul 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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