MedTrace Logo

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.

NCT00742495 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2012-10-24

No results posted yet for this study

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.

Conditions

  • Relapsed or Refractory T-cell Acute Lymphoblastic Leukaemia
  • B-cell Precursor Acute Lymphoblastic Leukaemia
  • T-cell Non-Hodgkin's Lymphoma

Interventions

DRUG

Forodesine

PK study

Sponsors & Collaborators

  • Innovative Therapies For Children with Cancer Consortium

    collaborator OTHER

  • Mundipharma Research Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Austria
  • Czechia
  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00742495 on ClinicalTrials.gov