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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930098
• Other study ID #: BIOV-111
• Secondary ID: UKCCSG: NAG 2003
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2009
• Last updated: February 10, 2014
• Start date: December 2003
• Est. completion date: July 2007

Study information

• Verified date: February 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ministry of HealthGermany: German Institute of Medical Documentation and InformationNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• clofarabine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company	Bioenvision

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

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