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)

This study has been terminated.
(Slow Recruitment)
Sponsor:
Collaborator:
Innovative Therapies for Children with Cancer (ITCC) Consortium
Information provided by:
Mundipharma Research Limited
ClinicalTrials.gov Identifier:
NCT00742495
First received: August 26, 2008
Last updated: October 23, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Relapsed or Refractory T-cell Acute Lymphoblastic Leukaemia
B-cell Precursor Acute Lymphoblastic Leukaemia
T-cell Non-Hodgkin's Lymphoma
Drug: Forodesine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Mundipharma Research Limited:

Primary Outcome Measures:
  • Pharmacokinetics and pharmacodynamics - data will be collected on Day 1, 5, 8 and 36. [ Time Frame: Day 1, and 36 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety data will be collected throughout the study. Efficacy will be assessed on Day 15 and Day 37. [ Time Frame: Day 15 and 37 ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: March 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Forodesine
    PK study
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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742495

Locations
Austria
Vienna, Austria
Czech Republic
Prague, Czech Republic
France
Prof Gerard Michel
Marseilles, France
Germany
Charite Universitymedicine
Berlin, Germany
Italy
Dr Giovanna Gioriani
Pavia, Italy
United Kingdom
Sally Kinsey
Leeds, United Kingdom
Sponsors and Collaborators
Mundipharma Research Limited
Innovative Therapies for Children with Cancer (ITCC) Consortium
  More Information

No publications provided

Responsible Party: Mundipharma Research Ltd
ClinicalTrials.gov Identifier: NCT00742495     History of Changes
Other Study ID Numbers: BCX1777-108, 2008-00221942
Study First Received: August 26, 2008
Last Updated: October 23, 2012
Health Authority: United Kingdom: Research Ethics Committee
Germany: Ethics Commission
Austria: Ethikkommission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
France: Institutional Ethical Committee
Czech Republic: Ethics Committee

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014