A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia

This study has been completed.
Sponsor:
Collaborator:
Bioenvision
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00930098
First received: June 17, 2009
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

This study is for a population of patients with few or no alternative options that was conducted to determine the response rate to clofarabine. Additionally the study will provide information on the safety profile, impact of overall survival, and impact on remission duration with clofarabine. It is a single arm study and has no comparator.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: clofarabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overall response rate after 1 course or more [ Time Frame: minimum of 1 course and maximum of 12 courses ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate after 2 courses or more [ Time Frame: minimum of 2 courses and maximum of 12 courses ] [ Designated as safety issue: No ]
  • Rate of response (complete, complete with incomplete blood count recovery, partial) after 1 course or more [ Time Frame: minimum of 1 course and maximum of 12 courses ] [ Designated as safety issue: No ]
  • Time-to-event parameters including duration of remission and overall survival [ Time Frame: Until death of patient or until end of study treatment for last enrolled patient ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Until death of patient or until end of study treatment for last enrolled patient ] [ Designated as safety issue: Yes ]
  • Number of patients received bone marrow or peripheral blood stem cell transplantation and the time to transplant following commencement of Clofarabine [ Time Frame: Until death of patient or until end of study treatment for last enrolled patient ] [ Designated as safety issue: No ]
  • Determine pharmacokinetic profile and intracellular triphosphate and levels of clofarabine [ Time Frame: every day during the first course of treatment ] [ Designated as safety issue: No ]
  • Document the metabolic pathways that may predict Clofarabine sensitivity or resistance [ Time Frame: day 1, day 5, day 6 and day 7 of the first course ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: December 2003
Study Completion Date: July 2007
Intervention Details:
    Drug: clofarabine
    Other Names:
    • US Tradename = Clolar
    • EU Tradename = Evoltra
Detailed Description:

Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of ALL and confirmed by pathologic assessment.
  • Be ≤ 21 years old at time of initial diagnosis.
  • Eligible patients must have: Primary refractory disease; OR relapsed or refractory disease after a minimum of 2 prior blocks of treatment.
  • Must not be eligible for therapy of higher curative potential.
  • Have a Karnofsky Performance Status of ≥ 50 or Lansky Performance Scale of ≥ 30.
  • Provide a signed, written informed consent from parent or guardian or young adult patients.
  • Be able to comply with study procedures and follow-up examinations.
  • Have adequate cardiac function without treatment.
  • Have adequate organ function as indicated by the laboratory values for serum creatinine, serum bilirubin, AST and ALT, obtained within 7 days prior to registration.

Exclusion Criteria:

  • Received previous treatment with clofarabine.
  • Patients with isolated extramedullary disease.
  • Have received prior BMT or PBSCT within the last 6 months.
  • Have received prior BMT or PBSCT more than 6 months ago, but now has compromised organ function.
  • Have an active, uncontrolled systemic infection.
  • Are pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy.
  • Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
  • Have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity oa all previous therapy prior to enrollment.
  • Have any other severe concurrent disease.
  • Have recent history of significant renal, hepatic or pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac function.
  • Have CNS disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930098

Locations
Austria
Vienna, Austria
France
Besancon, France
Bordeaux, France
Lille, France
Lyon, France
Marseille, France
Nantes, France
Paris, France
Toulouse, France
Vandoeuvre-les-Nancy, France
Germany
Berlin, Germany
Dusseldorf, Germany
Frankfurt, Germany
Hamburg, Germany
Hannover, Germany
Kiel, Germany
Muenster, Germany
Munich, Germany
Stuttgart, Germany
Italy
Monza, Italy
Pavia, Italy
Netherlands
Amsterdam, Netherlands
Groningen, Netherlands
Leiden, Netherlands
Rotterdam, Netherlands
Utrecht, Netherlands
United Kingdom
Birmingham, United Kingdom
Bristol, United Kingdom
Glasgow, United Kingdom
Leeds, United Kingdom
Liverpool, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Newcastle upon Tyne, United Kingdom
Sheffield, United Kingdom
Sutton, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Bioenvision
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00930098     History of Changes
Other Study ID Numbers: BIOV-111, UKCCSG: NAG 2003 06
Study First Received: June 17, 2009
Last Updated: February 10, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Germany: German Institute of Medical Documentation and Information
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Austria: Agency for Health and Food Safety

Keywords provided by Sanofi:
acute lymphoblastic leukemia
clolar
evoltra
clofarabine
refractory/relapsed acute leukemia
pediatric acute leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Clofarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014