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

Phase 2

Completed

• Conditions: Acute Leukemia
• Interventions: Drug: Clofarabine VP 16 ciclophospahamide

• Registration Number: NCT01385891
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-07
• Study Start: 2008-08
• Primary Completion: 2009-12
• Study Completion: 2010-02
• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Last Update Submitted: 2011-07-06
• Last Update Posted: 2011-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
children with advanced leukemia	Clofarabine VP 16 ciclophospahamide	-

Primary Outcome Measures

Name	Time	Method
response to treatment	after an expected average of 3 weeks after the first dose of each chemotherapy course

Secondary Outcome Measures

Name	Time	Method
Number of patients with toxicity as a measure of safety and tolerability	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)

Trial Locations

Locations (1)

G.Gaslini Children's Hospital; 🇮🇹 Genova, Italy