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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.
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
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| Phase II, Phase I | Biomarker/Laboratory analysis, Treatment | Active | 2 to 18 | 2008-00221942
BCX1777-108, NCT00742495 |
Trial Description
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. Further Study Information 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 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.
Trial Contact Information
Trial Lead Organizations/Sponsors Mundipharma International Limited Innovative Therapies for Children with Cancer (ITCC) Consortium
Trial Sites
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| Germany |
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Berlin |
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| | | | | | | | Charite Universitymedicine |
| | | Arend Von Stackelberg | |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00742495
Information obtained from ClinicalTrials.gov on April 24, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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