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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.


Phase 1/Phase 2
2 Years
18 Years
Not Enrolling
Both
Relapsed or Refractory T-cell Acute Lymphoblastic Leukaemia, B-cell Precursor Acute Lymphoblastic Leukaemia, T-cell Non-Hodgkin's Lymphoma

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Trial Information

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.


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Day 1, and 36

Safety Issue:

Yes

Authority:

United Kingdom: Research Ethics Committee

Study ID:

BCX1777-108

NCT ID:

NCT00742495

Start Date:

March 2009

Completion Date:

September 2010

Related Keywords:

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

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