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.

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Research Limited
• Collaborator: Innovative Therapies For Children with Cancer Consortium

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.