LeukemiaPhase 2NCT00419081
Study of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/Lymphoma Who Have Failed Two or More Prior Treatment Regimens
A Phase 2 study testing Forodesine Hydrochloride Sterile Solution, 5 mg/mL and Forodesine Hydrochloride Capsules (100 mg) in people with Leukemia and Lymphoma, run by BioCryst Pharmaceuticals at 5 sites in United States.
Trial summary
The purpose of this study is to determine whether Forodesine Hydrochloride is effective in treating patients with relapsed/refractory precursor T-Lymphoblastic Leukemia/Lymphoma who have failed two or more prior treatment regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Forodesine Hydrochloride Sterile Solution, 5 mg/mL and Forodesine Hydrochloride Capsules (100 mg)
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2006to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an unequivocal histologic diagnosis of precursor T-lymphoblastic leukemia/lymphoma (World Health Organization [WHO] classification).
- Failure to have responded to or relapsed after two or more treatment regimens for their disease, one of which could be HSCT.
- Performance status of 2 by Eastern Cooperative Oncology Group (ECOG) criteria (see Appendix A).
- Eighteen years of age and older.
- Life expectancy of at least three months.
- Adequate liver function (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] ≤3 times upper limit of normal), unless related to the underlying leukemia.
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- Negative serum or urine pregnancy test within two to seven days prior to the start of study treatment 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 in such a manner that the risk of pregnancy is minimized. Acceptable contraceptives include intra-uterine devices (IUDs), hormonal contraceptives (oral, depot, patch, or injectable), and double-barrier methods such as condoms or diaphragms with spermicidal gel or foam.
- Signed informed consent form (ICF) prior to start of any study-specific procedures.
- Willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability Act (HIPAA) policy (U.S. patients only).
Who cannot join
- Patients with known human immunodeficiency virus (HIV) infection or human T lymphotrophic virus 1 (HTLV-1).
- Patients with active hepatitis B or C infection.
- Patients with clinical evidence of active central nervous system (CNS) leukemia.
- Active serious infection not controlled by oral or intravenous antibiotics.
- Patients with a calculated creatinine clearance of <50 mL/min.
- Prior treatment with any investigational antileukemic or chemotherapy agent within seven days prior to study entry or lack of full recovery from side effects due to prior therapy, independent of when that therapy was given.
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- Rapidly progressive disease with compromised organ function judged to be life threatening by the Investigator.
- Concurrent treatment with other antileukemia agents (CNS prophylaxis [e.g., intrathecal methotrexate, cytarabine, or hydrocortisone] and corticosteroid use will not be excluded, but must first be approved by the Medical Monitor) (see Sections 9.2.1 and 9.2.2).
- Pregnant and/or lactating female.
- Patients who cannot swallow or who have chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the product.
- Hypersensitive or intolerant to any component of the study drug formulations.
- Patients who have received prior forodesine treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Chicago Medical Center
Chicago, Illinois, 60637
Liberty Hematology and Oncology
Columbia, South Carolina, 29203
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Louisana State University Health Sciences Center
Shreveport, Louisiana, 71103
New York Medical College Division of Oncology
Valhalla, New York, 10595
About this study
Official title: A Phase IIb, Multicenter, Open-Label, Nonrandomized, Repeat-Dose Study of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/Lymphoma Who Have Failed Two or More Prior Treatment Regimens.
The purpose of this study is to determine whether Forodesine Hydrochloride is effective in treating patients with relapsed/refractory precursor T-Lymphoblastic Leukemia/Lymphoma who have failed two or more prior treatment regimens.
- Being tested
- Forodesine Hydrochloride Sterile Solution, 5 mg/mL, Forodesine Hydrochloride Capsules (100 mg)
- Keywords
- leukemia, lymphoma
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forodesine Hydrochloride Sterile Solution, 5 mg/mLDrug
Forodesine Hydrochloride Capsules (100 mg)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the rate of complete remission for T lymphoblastic leukemia/lymphoma relapsed or refractory patients. The complete remission rate will be evaluated over the three-month Initial Treatment Period.
Secondary outcomes (8)
To determine the rate of CR achieved based on prior HSCT status
Assess safety and tolerability
Assess survival end points
Evaluate the maintenance and duration of response
Evaluate the proportion of patients able to proceed to HSCT
Evaluate the effects of this forodesine regimen on plasma levels of dGuo
Determine the effects of this forodesine regimen on clinical end points
Explore potential predictive biomarkers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startJul 2006
- Primary completionMar 2007
- Study completionMar 2007
Why it stopped: Issues with Manufacturing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Auro del Giglio, MD, Principal investigator, Faculdade de Medicina do ABCBelinda Pinto Simoes, MD, Principal investigator, Hospital das Clinicas de Faculdade de Medicina de Ribeirao PretoCarlos Sergio Chiattone, MD, Principal investigator, Irmandade da Santa Casa de Misercordia de Sao PauloCarmino Antonio de Souza, MD, Principal investigator, Hospital de Clinicias da UICAMP - Centro de Hematologia e HemoterapiaDavid Barqueti Jendiroba, MD, Principal investigator, Centro Goiano de OncologiaErnesto de Meis, MD, Principal investigator, INCA - Instituto Nacional de CancerFernando Antonio Sellos Ribeiro, MD, Principal investigator, Instituto Estadual de Hematologia Artur de Siqueira Cavalcanti - HEMORIOInes Guterres, MD, Principal investigator, Hospital Nossa Senhora de Conceicao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419081
- Sponsor's protocol ID
- BCX1777-Tio-05-202
- Status last verified
- Jan 2012
- First submitted
- 5 Jan 2007
- Last updated
- 23 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Multicenter, Open-Label, Nonrandomized, Repeat-Dose Study of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/Lymphoma Who Have Failed Two or More Prior Treatment Regimens.
- ClinicalTrials.gov ID
- NCT00419081
- Acronym / sponsor ID
- BCX1777-Tio-05-202
- Keywords
- leukemia, lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issues with Manufacturing
- Enrolment
- 100 participants
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 8 Jan 2007 (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 whether Forodesine Hydrochloride is effective in treating patients with relapsed/refractory precursor T-Lymphoblastic Leukemia/Lymphoma who have failed two or more prior treatment regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with an unequivocal histologic diagnosis of precursor T-lymphoblastic leukemia/lymphoma (World Health Organization [WHO] classification).
- Failure to have responded to or relapsed after two or more treatment regimens for their disease, one of which could be HSCT.
- Performance status of 2 by Eastern Cooperative Oncology Group (ECOG) criteria (see Appendix A).
- Eighteen years of age and older.
- Life expectancy of at least three months.
Key exclusion criteria (12 listed)
- Patients with known human immunodeficiency virus (HIV) infection or human T lymphotrophic virus 1 (HTLV-1).
- Patients with active hepatitis B or C infection.
- Patients with clinical evidence of active central nervous system (CNS) leukemia.
- Active serious infection not controlled by oral or intravenous antibiotics.
- Patients with a calculated creatinine clearance of <50 mL/min.
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 Sterile Solution, 5 mg/mL | Drug | – |
| Forodesine Hydrochloride Capsules (100 mg) | Drug | – |
Primary outcome
To determine the rate of complete remission for T lymphoblastic leukemia/lymphoma relapsed or refractory patients. The complete remission rate will be evaluated over the three-month Initial Treatment Period.
8 secondary outcomes
To determine the rate of CR achieved based on prior HSCT status
Assess safety and tolerability
Assess survival end points
Evaluate the maintenance and duration of response
Evaluate the proportion of patients able to proceed to HSCT
Evaluate the effects of this forodesine regimen on plasma levels of dGuo
Determine the effects of this forodesine regimen on clinical end points
Explore potential predictive biomarkers
Results and safety
The study was stopped early (reason given: Issues with Manufacturing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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.
Auro del Giglio, MD principal investigator
Faculdade de Medicina do ABC
Belinda Pinto Simoes, MD principal investigator
Hospital das Clinicas de Faculdade de Medicina de Ribeirao Preto
Carlos Sergio Chiattone, MD principal investigator
Irmandade da Santa Casa de Misercordia de Sao Paulo
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Forodesine Hydrochloride Sterile Solution, 5 mg/mL and Forodesine Hydrochloride Capsules (100 mg) in people with Leukemia and Lymphoma, run by BioCryst Pharmaceuticals at 5 sites 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 10 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 23 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 5 sites 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 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 was stopped early (reason given: Issues with Manufacturing). 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?
To determine the rate of complete remission for T lymphoblastic leukemia/lymphoma relapsed or refractory patients. The complete remission rate will be evaluated over the three-month Initial Treatment Period.. 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 23 Jan 2012.