Leukemia, T-CellPhase 2NCT00095381
Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
A Phase 2 study testing forodesine hydrochloride (BCX-1777) in people with Leukemia, T-Cell, run by BioCryst Pharmaceuticals at 24 sites in 2 countries.
Trial summary
BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia. Patients will receive an infusion of BCX-1777 on days 1-5. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia, T-Cell
- What is being tested?
- forodesine hydrochloride (BCX-1777)
- How many people
- 20 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Mar 2004to Dec 2007
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphomia or T-PLL)
- Failure to have responded to one or more standard regimens for their disease.
- Performance status of <=2 by Eastern Cooperative Oncology Group (ECOG) criteria
- All ages are eligible
- Life expectancy of at least 3 months
- Adequate liver function (aspartate transaminase [AST] and/or alanine transaminase [ALT] not >3 times upper limits or normal [ULN])
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- Adequate kidney function (calculated creatinine clearance >50 mL/min)
- Negative urine pregnancy test within 2 to 7 days prior to the start of study treamtment in females of childbearing potential
- Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study
- Signed informed consent/assent form (ICF) prior to start of any study specific procedures
Who cannot join
- Patients with known HIV infection or human T-cell leukemia virus type (HTLV-1)
- Patients with known Hepatitis B and/or Hepatitis C active infection
- Patients with active CMV infection
- Tumor-related central nervous system (CNS) leukemia requiring active treatment
- Active serious infection not controlled by oral or IV antibiotics
- Treatment with any investigational anti-leukemic agent or chemotherapy agent within 7 days prior to study entry, unless full recovery from side effects has occurred.
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- Rapidly progressive disease with compromised organ function judged to be life-threatening by the investigator
- Concurrent treatment with other anticancer agents (corticosteroid use will not be excluded, but patient must remain on the stable dose)
- Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary Syndrome)
- Pregnant and/or lactating women
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States23 sites
Study site
Abingdon, Virginia, 24211
Study site
Atlanta, Georgia, 30322
Study site
Austin, Texas, 78701
Study site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60637
Study site
Denver, Colorado, 80262
Study site
Detroit, Michigan, 48202
Study site
Gainesville, Florida, 32611
Study site
Hackensack, New Jersey, 07601
Study site
Houston, Texas, 77030
Study site
Kansas City, Kansas, 66160
Study site
Lecanto, Florida, 34461
Study site
Los Angeles, California, 90024
Study site
New Orleans, Louisiana, 70118
Weil Medical College of Cornell University
New York, New York, 10021
Study site
New York, New York, 10021
Study site
Omaha, Nebraska, 68198
Study site
Palo Alto, California, 94304
Study site
Rolla, Missouri, 65401
Study site
Spartanburg, South Carolina, 29303
Study site
St Louis, Missouri, 63110
Study site
Syracuse, New York, 13210
Study site
The Bronx, New York, 10467
About this study
Official title: A Phase II, Multi-Center Open-Label, Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia With an Option of Long-Term Forodesine Hydrochloride (BCX-1777) Use
BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.
Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every week for up to six courses. Patients are not required to be hospitalized for the administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777 twice a week for 6 weeks.
Read the detailed description
BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.
- Conditions
- Leukemia, T-Cell
- Being tested
- forodesine hydrochloride (BCX-1777)
- Keywords
- Leukemia, Lymphocytic, T-Cell, Entry Term Lymphocytic Leukemia, T-Cell, T-Cell Leukemia, T-Lymphocytic Leukemia, Leukemia, Lymphocytic, T Cell, T Lymphocytic Leukemia, BCX-1777, forodesine hydrochloride, BioCryst
- Medical subject headings
- Leukemia, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
forodesine hydrochloride (BCX-1777)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)
Secondary outcomes (3)
Safety and tolerability
Pharmacokinetics (PK) and Pharmacodynamics (PD)
maintenance of response and safety in long-term treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2004 (estimated)
- Study startMar 2004
- Primary completionMar 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, T-CellStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095381
- Sponsor's protocol ID
- BCX1777-T-04-201
- Status last verified
- Jan 2012
- First submitted
- 3 Nov 2004
- Last updated
- 19 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-Center Open-Label, Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia With an Option of Long-Term Forodesine Hydrochloride (BCX-1777) Use
- ClinicalTrials.gov ID
- NCT00095381
- Acronym / sponsor ID
- BCX1777-T-04-201
- Conditions
- Leukemia, T-Cell
- Keywords
- Leukemia, Lymphocytic, T-Cell, Entry Term Lymphocytic Leukemia, T-Cell, T-Cell Leukemia, T-Lymphocytic Leukemia, Leukemia, Lymphocytic, T Cell, T Lymphocytic Leukemia, BCX-1777, forodesine hydrochloride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Nov 2004 (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.
BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.
Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every week for up to six courses. Patients are not required to be hospitalized for the administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777 twice a week for 6 weeks.
Detailed description
BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphomia or T-PLL)
- Failure to have responded to one or more standard regimens for their disease.
- Performance status of <=2 by Eastern Cooperative Oncology Group (ECOG) criteria
- All ages are eligible
- Life expectancy of at least 3 months
Key exclusion criteria (10 listed)
- Patients with known HIV infection or human T-cell leukemia virus type (HTLV-1)
- Patients with known Hepatitis B and/or Hepatitis C active infection
- Patients with active CMV infection
- Tumor-related central nervous system (CNS) leukemia requiring active treatment
- Active serious infection not controlled by oral or IV antibiotics
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 |
|---|---|---|
| forodesine hydrochloride (BCX-1777) | Drug | – |
Primary outcome
Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)
3 secondary outcomes
Safety and tolerability
Pharmacokinetics (PK) and Pharmacodynamics (PD)
maintenance of response and safety in long-term treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 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.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing forodesine hydrochloride (BCX-1777) in people with Leukemia, T-Cell, run by BioCryst Pharmaceuticals at 24 sites in 2 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Georgia. 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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL). 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 19 Jan 2012.