Leukemia, Lymphocytic, ChronicPhase 2NCT00289549
Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing forodesine hydrochloride (BCX-1777) in people with Leukemia, Lymphocytic, Chronic, run by BioCryst Pharmaceuticals at 1 site in United States.
Trial summary
Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy (28 days). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic
- What is being tested?
- forodesine hydrochloride (BCX-1777)
- Type of treatment
- Pill or oral medicine
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jan 2009
- 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
- Ages 18 years and older
- Diagnosis of CLL established by peripheral blood and bone marrow examination and using the standard criteria
- Patients with Rai stage III or IV, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy
- Primary resistance to fludarabine-based therapy (no complete response [CR] or partial response [PR]) or progressive disease within 6 months of response to prior fludarabine containing regimen.
- ECOG performance status of 0, 1, 2 or 3
- Willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after
- All investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug.
Who cannot join
- Pregnant or nursing
- Unable or unwilling to sign consent
- Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy
- Active serious infections that are not controlled by antibiotics
- ECOG performance status 4
- Inadequate renal function: creatinine 2.0 or more unless related to the disease
Show all 9Show fewer
- Inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease
- Known positive test for HIV
- Patients with known hepatitis B and/or hepatitis C active infection
Trial locations and contacts
1 site in 1 country.
United States1 site
MD Anderson Cancer Center, University of Texas
Houston, Texas, 77030
About this study
Official title: Phase II Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL)
Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy (28 days).
- Conditions
- Leukemia, Lymphocytic, Chronic
- Being tested
- forodesine hydrochloride (BCX-1777)
- Keywords
- CLL, Chronic lymphocytic leukemia, leukemia, Advanced, fludarabine-refractory CLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
forodesine hydrochloride (BCX-1777)Drug
experimental, forodesine oral dose 200 mg administered daily.
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate after 2 cyclesof forodesine therapy.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startJun 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Lymphocytic, ChronicStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Farhad Ravandi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289549
- Sponsor's protocol ID
- BCX1777-Bo-05-204
- Status last verified
- Feb 2012
- First submitted
- 8 Feb 2006
- Last updated
- 8 Feb 2012
- Results posted
- No
Publications
Balakrishnan K, Verma D, O'Brien S, Kilpatrick JM, Chen Y, Tyler BF, Bickel S, Bantia S, Keating MJ, Kantarjian H, Gandhi V, Ravandi F. Phase 2 and pharmacodynamic study of oral forodesine in patients with advanced, fludarabine-treated chronic lymphocytic leukemia. Blood. 2010 Aug 12;116(6):886-92. doi: 10.1182/blood-2010-02-272039. Epub 2010 Apr 28.
PubMed 20427701
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT00289549
- Acronym / sponsor ID
- BCX1777-Bo-05-204
- Conditions
- Leukemia, Lymphocytic, Chronic
- Keywords
- CLL, Chronic lymphocytic leukemia, leukemia, Advanced, fludarabine-refractory CLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Feb 2006 (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.
Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy (28 days).
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 (7 listed)
- Ages 18 years and older
- Diagnosis of CLL established by peripheral blood and bone marrow examination and using the standard criteria
- Patients with Rai stage III or IV, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy
- Primary resistance to fludarabine-based therapy (no complete response [CR] or partial response [PR]) or progressive disease within 6 months of response to prior fludarabine containing regimen.
- ECOG performance status of 0, 1, 2 or 3
Key exclusion criteria (9 listed)
- Pregnant or nursing
- Unable or unwilling to sign consent
- Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy
- Active serious infections that are not controlled by antibiotics
- ECOG performance status 4
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)experimental, forodesine oral dose 200 mg administered daily. | Drug | – |
Primary outcome
Response rate after 2 cyclesof forodesine therapy.
Time frame: 8 weeks
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 8 Feb 2012.
- Derived from this study: PubMed 20427701Balakrishnan K, Verma D, O'Brien S, Kilpatrick JM, Chen Y, Tyler BF, Bickel S, Bantia S, Keating MJ, Kantarjian H, Gandhi V, Ravandi F. Phase 2 and pharmacodynamic study of oral forodesine in patients with advanced, fludarabine-treated chronic lymphocytic leukemia. Blood. 2010 Aug 12;116(6):886-92. doi: 10.1182/blood-2010-02-272039. Epub 2010 Apr 28.
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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.
Farhad Ravandi, MD 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 2 study testing forodesine hydrochloride (BCX-1777) in people with Leukemia, Lymphocytic, Chronic, 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 9 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 8 Feb 2012. 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 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?
Response rate after 2 cyclesof forodesine therapy. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00289549, which also lists 1 linked publication.
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 8 Feb 2012.