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

NCT01385891 | Completed Phase 2 DMC

• 2 other identifiers: CM0012008-004487-39
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• response to treatment

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

Secondary Outcomes (1)

• 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

Study Arms (1)

children with advanced leukemia

EXPERIMENTAL

Drug: Clofarabine VP 16 ciclophospahamide

Interventions

Clofarabine VP 16 ciclophospahamide DRUG

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

Also known as: Evoltra, Etoposide, Endoxan

children with advanced leukemia

Eligibility Criteria

• Age: 1 Month - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• isolated extra-medullary relapse, and active infections

Sponsors & Collaborators

• Istituto Giannina Gaslini: lead

Study Sites (1)

G.Gaslini Children's Hospital

Genova, 16147, Italy

Location

MeSH Terms

Interventions

Clofarabine; Etoposide; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Concetta Micalizzi, MD

  G. Gaslini Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 30, 2011
• Study Start: August 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: July 8, 2011

Record last verified: 2008-07

Locations

IT (1)