Chronic Lymphocytic Leukemia (CLL)Phase 2NCT00640523
Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing forodesine HCl in people with Chronic Lymphocytic Leukemia (CLL), run by BioCryst Pharmaceuticals at 11 sites in 2 countries.
Trial summary
To evaluate the effectiveness and safety of forodesine in CLL patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL)
- What is being tested?
- forodesine HCl
- Type of treatment
- Pill or oral medicine
- How many people
- 23 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Mar 2008to Nov 2011
- 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
- Age 18 years and older
- Diagnosis of CLL established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria.
- Subjects with Rai stage III or IV, or earlier stage requiring therapy as determined by the 1996 National Cancer Institute -Working Group (NCI-WG) criterion
- Primary resistant (no CR or PR) or progressive disease after response to at least one prior treatment regimen OR treatment naïve subjects who meet at least one of the following criteria.
- age >65 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4
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- Inability to tolerate standard cytotoxic chemotherapy in the opinion of the treating physician.
- ECOG performance status of 0, 1, or 2 (for subjects with primary resistance or progressive disease after response to at least one prior treatment regimen).
- Willing to take adequate contraceptive measures (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after, except for patients who are post menopausal or have prior hysterectomy.
- All investigational treatments should have been discontinued for at least 3 weeks 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 >2 (except for treatment naïve subjects where ECOG performance status 0, 1 or 5 is excluded).
- Inadequate renal function: creatinine > or equal to 2.0 unless related to the disease.
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- Inadequate liver function: bilirubin > or equal to 3.0; transaminases > or equal to 3.0 times the upper limit of normal unless related to the disease.
- Known positive test for human immunodeficiency virus (HIV).
- Subjects with known hepatitis B and/or hepatitis C active infection.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States8 sites
Center for Cancer & Blood Disorders, PC
Bethesda, Maryland, 20817
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Roswell Park Cancer Institute
Buffalo, New York, 14263
Indiana University Cancer Pavillion
Indianapolis, Indiana, 46202
UCLA Medical Center
Los Angeles, California, 90095
Weill Cornell Medical College
New York, New York, 10065
Oregon Health & Science University
Portland, Oregon, 97239
Washington University School of Medicine
St Louis, Missouri, 63110
Australia3 sites
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Frankston Hospital
Frankston, Victoria, 3199
Cabrini Hospital
Malvern, Victoria, 3144
About this study
To evaluate the effectiveness and safety of forodesine in CLL patients
Read the detailed description
To investigate the efficacy (complete response [CR] + partial response [PR]) of forodesine in treating subjects with CLL who have failed at least one prior treatment regimen or who are treatment naïve but are either elderly, have poor performance status or are otherwise predicted not to tolerate cytotoxic chemotherapy.
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Being tested
- forodesine HCl
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
forodesine HClDrug
2 x 100mg capsules daily
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: Up to 6 cycles of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asher Chanan-Khan, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640523
- Sponsor's protocol ID
- BCX1777-210
- Status last verified
- Jan 2012
- First submitted
- 17 Mar 2008
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
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
- Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT00640523
- Acronym / sponsor ID
- BCX1777-210
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 21 Mar 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.
To evaluate the effectiveness and safety of forodesine in CLL patients
Detailed description
To investigate the efficacy (complete response [CR] + partial response [PR]) of forodesine in treating subjects with CLL who have failed at least one prior treatment regimen or who are treatment naïve but are either elderly, have poor performance status or are otherwise predicted not to tolerate cytotoxic chemotherapy.
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)
- Age 18 years and older
- Diagnosis of CLL established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria.
- Subjects with Rai stage III or IV, or earlier stage requiring therapy as determined by the 1996 National Cancer Institute -Working Group (NCI-WG) criterion
- Primary resistant (no CR or PR) or progressive disease after response to at least one prior treatment regimen OR treatment naïve subjects who meet at least one of the following criteria.
- ECOG performance status of 0, 1, or 2 (for subjects with primary resistance or progressive disease after response to at least one prior treatment regimen).
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 >2 (except for treatment naïve subjects where ECOG performance status 0, 1 or 5 is excluded).
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 HCl2 x 100mg capsules daily | Drug | – |
Primary outcome
Overall response rate
Time frame: Up to 6 cycles of therapy
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 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.
Asher Chanan-Khan, MD principal investigator
Roswell Park Cancer Institute
11 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 HCl in people with Chronic Lymphocytic Leukemia (CLL), run by BioCryst Pharmaceuticals at 11 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 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 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 11 sites in United States, Australia. 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?
Overall response rate (time frame: Up to 6 cycles of therapy). 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.