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

Istituto Giannina Gaslini

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Leukemia

Treatments: Drug: Clofarabine VP 16 ciclophospahamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01385891

2008-004487-39 (EudraCT Number)

CM001

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 1 month to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

children with advanced leukemia

Experimental group

Treatment:

Drug: Clofarabine VP 16 ciclophospahamide