Trials / Terminated
TerminatedNCT00742495
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.
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.
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Mundipharma Research Limited · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Relapsed or Refractory T-cell Acute Lymphoblastic Leukaemia
- B-cell Precursor Acute Lymphoblastic Leukaemia
- T-cell Non-Hodgkin's Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Forodesine | PK study |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2010-09-01
- Completion
- 2010-09-01
- First posted
- 2008-08-27
- Last updated
- 2012-10-24
Locations
6 sites across 6 countries: Austria, Czechia, France, Germany, Italy, United Kingdom
Source: ClinicalTrials.gov record NCT00742495. Inclusion in this directory is not an endorsement.