Relapsed or Refractory T-cell Acute Lymphoblastic LeukaemiaPhase 1/2BCX1777-108NCT00742495
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 1/2 study testing Forodesine in people with Relapsed or Refractory T-cell Acute Lymphoblastic Leukaemia and B-cell Precursor Acute Lymphoblastic Leukaemia, run by Mundipharma Research Limited at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Relapsed or Refractory T-cell Acute Lymphoblastic Leukaemia, B-cell Precursor Acute Lymphoblastic Leukaemia, T-cell Non-Hodgkin's Lymphoma
- What is being tested?
- Forodesine
- How many people
- 2 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Mar 2009to Sep 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official 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.
Read the 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
- Being tested
- Forodesine
- Medical subject headings
- Recurrence, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForodesineDrug
PK study
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics and pharmacodynamics - data will be collected on Day 1, 5, 8 and 36.
Measured: 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.
Measured: Day 15 and 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startMar 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Slow Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory T-cell Acute Lymphoblastic LeukaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovative Therapies For Children with Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742495
- Sponsor's protocol ID
- BCX1777-108
- Other IDs
- 2008-00221942, 2008
- Acronym
- BCX1777-108
- Status last verified
- Feb 2012
- First submitted
- 26 Aug 2008
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00742495
- Acronym / sponsor ID
- BCX1777-108 / BCX1777-108
- Conditions
- Relapsed or Refractory T-cell Acute Lymphoblastic Leukaemia, B-cell Precursor Acute Lymphoblastic Leukaemia, T-cell Non-Hodgkin's Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Innovative Therapies For Children with Cancer Consortium
- Study start
- Mar 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ForodesinePK study | Drug | – |
Primary outcome
Pharmacokinetics and pharmacodynamics - data will be collected on Day 1, 5, 8 and 36.
Time frame: Day 1, and 36
1 secondary outcome
Safety data will be collected throughout the study. Efficacy will be assessed on Day 15 and Day 37.
Time frame: Day 15 and 37
Results and safety
The study was stopped early (reason given: Slow Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Forodesine in people with Relapsed or Refractory T-cell Acute Lymphoblastic Leukaemia and B-cell Precursor Acute Lymphoblastic Leukaemia, run by Mundipharma Research Limited at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria, Czechia, France, Germany, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow Recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics and pharmacodynamics - data will be collected on Day 1, 5, 8 and 36. (time frame: Day 1, and 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.