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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01385891

Acronym

CLOVE

Enrollment

Registered

2011-06-30

Start date

2008-08-31

Completion date

2010-02-28

Last updated

2011-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia

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

Interventions

DRUGClofarabine VP 16 ciclophospahamide

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 20 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026