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 | Terminated Phase 1 DMC

• 2 other identifiers: BCX1777-1082008-00221942
• Study Type: interventional
• Target: 2
• Locations: 6 countries
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics and pharmacodynamics - data will be collected on Day 1, 5, 8 and 36.

  Day 1, and 36

Secondary Outcomes (1)

• Safety data will be collected throughout the study. Efficacy will be assessed on Day 15 and Day 37.

  Day 15 and 37

Interventions

Forodesine DRUG

PK study

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma Research Limited: lead
• Innovative Therapies For Children with Cancer Consortium: collaborator

Study Sites (6)

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Prague, Czechia

Location

Prof Gerard Michel

Marseille, France

Location

Charite Universitymedicine

Berlin, Germany

Location

Dr Giovanna Gioriani

Pavia, Italy

Location

Sally Kinsey

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Recurrence; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, T-Cell

Interventions

forodesine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 27, 2008
• Study Start: March 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 24, 2012

Record last verified: 2012-02

Locations

AU (1); CZ (1); FR (1); DE (1); IT (1); GB (1)