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

Istituto Giannina Gaslini40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Leukemia

Interventions

Clofarabine VP 16 ciclophospahamideDRUG

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

Eligibility

Sex: ALLMin age: 1 MonthMax age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

G.Gaslini Children's Hospital

Genova, Italy

Outcomes

Primary Outcomes

response to treatment

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

Secondary Outcomes

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)

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

Data from ClinicalTrials.gov

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