T-cell Non-Hodgkin's Lymphoma Clinical Trial
— BCX1777-108Official 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.
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.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | September 2010 |
| Est. primary completion date | September 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 18 Years |
| Eligibility |
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 ß-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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Prof Gerard Michel | Marseilles | |
| Germany | Charite Universitymedicine | Berlin | |
| Italy | Dr Giovanna Gioriani | Pavia | |
| United Kingdom | Sally Kinsey | Leeds |
| Lead Sponsor | Collaborator |
|---|---|
| Mundipharma Research Limited | Innovative Therapies For Children with Cancer Consortium |
Austria, Czech Republic, France, Germany, Italy, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pharmacokinetics and pharmacodynamics - data will be collected on Day 1, 5, 8 and 36. | Day 1, and 36 | Yes | |
| Secondary | Safety data will be collected throughout the study. Efficacy will be assessed on Day 15 and Day 37. | Day 15 and 37 | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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