Leukemia, LymphocyticPhase 1/2NCT00035022
Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive T-Cell Leukemias or Lymphomas
A Phase 1/2 study testing BCX-1777 in people with Leukemia, Lymphocytic and Lymphoma, run by BioCryst Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to determine if intravenous BCX-1777 can be given safely to improve relapsed or refractory aggressive T-cell leukemias and lymphomas. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Lymphoma
- What is being tested?
- BCX-1777
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Mar 2004
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previously treated, relapsed or refractory aggressive T-cell malignancies (leukemias and lymphomas) histologically proven with measurable disease.
- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- All ages are eligible. Pediatric patients (<15 years of age) are eligible to be treated at a dose level previously tested in adults.
- Adequate liver and renal function.
- Patients with prior history of stem cell transplant if they meet all other eligibility requirements.
- Negative pregnancy test within 72 hours of study treatment in females of childbearing potential.
- Life expectancy of at least 2 months.
Who cannot join
- Active serious infection not controlled by oral or intravenous antibiotics.
- Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator.
- Concurrent treatment with other anti-cancer agents.
- Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy. Lumbar puncture not required in asymptomatic patients.
- Pregnant and/or lactating women; or fertile men or women not willing to use contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I-II Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive (High Grade) T-Cell Malignancies
The purpose of this study is to determine if intravenous BCX-1777 can be given safely to improve relapsed or refractory aggressive T-cell leukemias and lymphomas.
Read the detailed description
Despite the great strides that have been made in improving the outcome with frontline programs of intensive chemotherapy in patients with aggressive T-cell malignancies, the prognosis with relapsed or refractory T-cell leukemias or lymphomas is poor. BCX-1777 is a purine nucleoside phosphorylase (PNP) inhibitor and a potential T-cell target therapy.
The purpose of the phase I portion of the study is to determine the maximum tolerated dose (MTD) of BCX-1777 and the dose to be studied in the phase II portion of the study.
The purpose of the phase II portion of the study is to determine the safety and efficacy of BCX-1777 in patients with relapsed or refractory aggressive T-cell malignancies.
Patients who respond to BCX-1777 or have stable disease may be eligible to receive an additional course of treatment.
- Conditions
- Leukemia, Lymphocytic, Lymphoma
- Being tested
- BCX-1777
- Keywords
- Leukemia, Lymphoma, T-Cell
- Medical subject headings
- Leukemia, Lymphoid, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCX-1777Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startAug 2001
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, LymphocyticStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Deborah A. Thomas, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035022
- Sponsor's protocol ID
- BC-01-02
- Status last verified
- Feb 2005
- First submitted
- 2 May 2002
- Last updated
- 13 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive (High Grade) T-Cell Malignancies
- ClinicalTrials.gov ID
- NCT00035022
- Acronym / sponsor ID
- BC-01-02
- Conditions
- Leukemia, Lymphocytic, Lymphoma
- Keywords
- Leukemia, Lymphoma, T-Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Study completion
- Mar 2004
- First posted
- 3 May 2002 (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 determine if intravenous BCX-1777 can be given safely to improve relapsed or refractory aggressive T-cell leukemias and lymphomas.
Detailed description
Despite the great strides that have been made in improving the outcome with frontline programs of intensive chemotherapy in patients with aggressive T-cell malignancies, the prognosis with relapsed or refractory T-cell leukemias or lymphomas is poor. BCX-1777 is a purine nucleoside phosphorylase (PNP) inhibitor and a potential T-cell target therapy.
The purpose of the phase I portion of the study is to determine the maximum tolerated dose (MTD) of BCX-1777 and the dose to be studied in the phase II portion of the study.
The purpose of the phase II portion of the study is to determine the safety and efficacy of BCX-1777 in patients with relapsed or refractory aggressive T-cell malignancies.
Patients who respond to BCX-1777 or have stable disease may be eligible to receive an additional course of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Previously treated, relapsed or refractory aggressive T-cell malignancies (leukemias and lymphomas) histologically proven with measurable disease.
- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- All ages are eligible. Pediatric patients (<15 years of age) are eligible to be treated at a dose level previously tested in adults.
- Adequate liver and renal function.
- Patients with prior history of stem cell transplant if they meet all other eligibility requirements.
Key exclusion criteria (5 listed)
- Active serious infection not controlled by oral or intravenous antibiotics.
- Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator.
- Concurrent treatment with other anti-cancer agents.
- Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy. Lumbar puncture not required in asymptomatic patients.
- Pregnant and/or lactating women; or fertile men or women not willing to use contraception.
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 |
|---|---|---|
| BCX-1777 | Drug | – |
Primary outcome
Not reported in the source record.
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 13 Jan 2006.
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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.
Deborah A. Thomas, M.D. principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BCX-1777 in people with Leukemia, Lymphocytic and Lymphoma, run by BioCryst Pharmaceuticals at 1 site in United States.
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 7 inclusion and 5 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 13 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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.
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 13 Jan 2006.