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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Giannina Gaslini
• Treatments: Clofarabine; Etoposide; Etoposide phosphate

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