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

February 10, 2014 updated by: Genzyme, a Sanofi Company

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.

Study Overview

Status

Completed

Conditions

Acute Lymphoblastic Leukemia

Intervention / Treatment

Drug: clofarabine

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall response rate after 1 course or more Time Frame: minimum of 1 course and maximum of 12 courses	minimum of 1 course and maximum of 12 courses

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall response rate after 2 courses or more Time Frame: minimum of 2 courses and maximum of 12 courses	minimum of 2 courses and maximum of 12 courses
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	minimum of 1 course and maximum of 12 courses
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	Until death of patient or until end of study treatment for last enrolled patient
Safety and tolerability Time Frame: Until death of patient or until end of study treatment for last enrolled patient	Until death of patient or until end of study treatment for last enrolled patient
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	Until death of patient or until end of study treatment for last enrolled patient
Determine pharmacokinetic profile and intracellular triphosphate and levels of clofarabine Time Frame: every day during the first course of treatment	every day during the first course of treatment
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	day 1, day 5, day 6 and day 7 of the first course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Collaborators

Bioenvision

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (ESTIMATE)

June 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2014

Last Update Submitted That Met QC Criteria

February 10, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

BIOV-111
UKCCSG: NAG 2003 06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.