Pharmacokinetic Study of Forodesine in Children With Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin's Lymphoma. (BCX1777-108)

October 23, 2012 updated by: Mundipharma Research Limited

A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children With Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non-Hodgkin's Lymphoma.

The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics and safety of different doses of intravenous and oral Forodesine in children with relapsed or refractory T-cell or B-cell precursor Acute Lymphoblastic Leukaemia or T-cell Non-Hodgkin's Lymphoma. Preliminary efficacy will also be assessed.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A multi-centre, multi-national, open label trial of Forodesine in children with relapsed or refractory T-cell or B-cell precursor Acute Lymphoblastic Leukaemia or T-cell Non-Hodgkin's Lymphoma. The primary objective of the study is to evaluate the pharmacokinetics and pharmacodynamics of six different dose schedules of Forodesine. Secondary objectives are to evaluate safety and to collect preliminary efficacy data. All patients will receive active drug. The Initial Treatment Phase will last 37 days with a final response assessment on Day 37. Patients who achieve a response may be eligible to receive extended treatment with Forodesine for up to 6 months.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2
  • Phase 1

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

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

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females aged ≥ 2 years to ≤18 years. ≥ 13 kg
  • Female subjects of childbearing potential (i.e. have reached the age of menarche) must have a negative serum or urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and be willing to use adequate and highly effective method of contraception throughout the study and for one month after the last dose of study medication, if sexually active.
  • Sexually active male subjects must be willing and able to use a barrier form of contraception (i.e. condoms) or sexual abstinence throughout the study and for one month after the last dose of study medication
  • Unequivocal histological diagnosis of T-ALL, BCP-ALL or T-NHL (World Health Organisation [WHO] classification) at initial diagnosis
  • Relapse (³25% marrow blasts) or failure to respond after at least one standard regimen for their disease for subjects with a T-cell malignancy who are ineligible for other therapy of greater curative potential, or failure to respond after at least two standard regimens for subjects with a B-cell precursor malignancy
  • KPS or LPS (as appropriate for subject's age) scores ³60
  • Anticipated life expectancy of at least 6 weeks
  • Adequate kidney (creatinine levels ≤ 2.0 times upper limit of normal) and liver function tests (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] ≤3 times upper limit of normal and total bilirubin ≤5 times upper limit of normal)
  • Signed ICF and assent if appropriate according to local laws and regulations prior to start of any study specific procedures.

Exclusion criteria:

  • Females who are pregnant (positive β-hCG test) or lactating
  • Subjects with a history of HIV and/or HTLV-1
  • Subjects with known active HBV, HCV, CMV and/or EBV infection
  • Subjects with clinical evidence of active symptomatic CNS disease
  • Subjects with active serious infection
  • Prior treatment with any antileukemic agent, chemotherapy or leukophoresis treatment within 7 days (within 4-5 days for 6-mercaptopurine (MP) and within 2 days for low-dose methotrexate) prior to study entry
  • Lack of full recovery from adverse drug reactions due to prior therapy, independent of when that therapy was given
  • Concurrent treatment with other anticancer agents (CNS prophylaxis e.g. intrathecal methotrexate and corticosteroid use will not be excluded)
  • Subjects who have chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the product; however, study drug administration via nasogastric or gastrostomy tube is allowed
  • Any history of hypersensitivity or intolerance to any component of the study medication.
  • Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).
  • Current participation in another clinical trial is not permitted unless the sole purpose of the trial is for long term follow up/survival data.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics and pharmacodynamics - data will be collected on Day 1, 5, 8 and 36.
Time Frame: Day 1, and 36
Day 1, and 36

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety data will be collected throughout the study. Efficacy will be assessed on Day 15 and Day 37.
Time Frame: Day 15 and 37
Day 15 and 37

Collaborators and Investigators

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

Sponsor

Mundipharma Research Limited

Collaborators

Innovative Therapies For Children with Cancer Consortium

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

March 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 26, 2008

First Posted (Estimate)

August 27, 2008

Study Record Updates

Last Update Posted (Estimate)

October 24, 2012

Last Update Submitted That Met QC Criteria

October 23, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCX1777-108
  • 2008-00221942

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.

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