Severe Chronic NeutropeniaPhase 2NCT00909584
Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia
A Phase 2 study testing Ezatiostat Hydrochloride in people with Severe Chronic Neutropenia, run by Telik at 4 sites in United States.
Trial summary
This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or enter an observation period with an option to crossover to Telintra treatment in a 1:1 allocation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Chronic Neutropenia
- What is being tested?
- Ezatiostat Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2009to May 2013
- 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
- Confirmed Idiopathic Severe Chronic Neutropenia
- ECOG performance status of 0-2
- Adequate liver and renal function
- Adequate Red Blood Cell and Platelet counts
Who cannot join
- Prior treatment of SCN
- Non-Idiopathic types of SCN, ie. cyclic, congenital
- History of chromosomal abnormalities, myelodysplasia, hematologic malignancy, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis (Felty's syndrome), or other collagen diseases, and drug-induced neutropenia, autoimmune neutropenia
- Use of granulocyte colony stimulating factors (G-CSF), glucocorticoids, gamma globulin, lithium or investigational drug(s) within one month of enrollment
- History of bone marrow transplantation or stem cell support
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109-0238
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Cancer Care Centers of South Texas
San Antonio, Texas, 78229
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Severe Chronic Neutropenia
This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or enter an observation period with an option to crossover to Telintra treatment in a 1:1 allocation.
- Conditions
- Severe Chronic Neutropenia
- Being tested
- Ezatiostat Hydrochloride
- Keywords
- Hematology, Neutropenia, SCN, Severe Chronic Neutropenia, Idiopathic, Telintra, ezatiostat hydrochloride, ezatiostat, TLK199, Glutathione, Glutathione analog, Glutathione Transferase, Glutathione Transferase inhibitor, Glutathione Transferase P1-1 inhibitor, GSTp1-1 inhibitor, Apoptosis, Differentiation, Enzyme inhibitor
- Medical subject headings
- Neutropenia, severe chronic, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezatiostat HydrochlorideDrug
Also called Telintra tablets, TLK199 Tablets
Starting Dose 2000 mg orally per day in two divided doses with dose to increase or decrease to achieve target median ANC (Range 1,500-10,000 cells/uL)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 4-Week dose equilibration period with Telintra followed by 4 month treatment period Receives: Drug: Ezatiostat Hydrochloride |
| 2 | No intervention | 4 Month observation period with standard of care treatment and option to crossover to Telintra treatment for 4 week dose equilibration followed by 4 week treatment period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective absolute neutrophil count (ANC) response rate
Measured: 18 Months
Secondary outcomes (4)
Incidence of infections, oropharyngeal ulcers and antibiotic use
Measured: 18 Months
Incidence and duration of hospitalizations
Measured: 18 Months
FACT-N quality of life assessment
Measured: 18 Months
Safety assessments
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Study TLK199.2103 was terminated for business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Chronic NeutropeniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telik
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Brown, MD, Study director, Telik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909584
- Sponsor's protocol ID
- TLK199.2103
- Status last verified
- Nov 2013
- First submitted
- 26 May 2009
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Severe Chronic Neutropenia
- ClinicalTrials.gov ID
- NCT00909584
- Acronym / sponsor ID
- TLK199.2103
- Conditions
- Severe Chronic Neutropenia
- Keywords
- Hematology, Neutropenia, SCN, Severe Chronic Neutropenia, Idiopathic, Telintra, ezatiostat hydrochloride, ezatiostat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study TLK199.2103 was terminated for business reasons.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- TelikIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 May 2009 (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.
This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or enter an observation period with an option to crossover to Telintra treatment in a 1:1 allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ezatiostat Hydrochloride4-Week dose equilibration period with Telintra followed by 4 month treatment period |
| 2 | No intervention | –4 Month observation period with standard of care treatment and option to crossover to Telintra treatment for 4 week dose equilibration followed by 4 week treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed Idiopathic Severe Chronic Neutropenia
- ECOG performance status of 0-2
- Adequate liver and renal function
- Adequate Red Blood Cell and Platelet counts
Key exclusion criteria (5 listed)
- Prior treatment of SCN
- Non-Idiopathic types of SCN, ie. cyclic, congenital
- History of chromosomal abnormalities, myelodysplasia, hematologic malignancy, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis (Felty's syndrome), or other collagen diseases, and drug-induced neutropenia, autoimmune neutropenia
- Use of granulocyte colony stimulating factors (G-CSF), glucocorticoids, gamma globulin, lithium or investigational drug(s) within one month of enrollment
- History of bone marrow transplantation or stem cell support
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 |
|---|---|---|
| Ezatiostat HydrochlorideAlso: Telintra tablets, TLK199 TabletsStarting Dose 2000 mg orally per day in two divided doses with dose to increase or decrease to achieve target median ANC (Range 1,500-10,000 cells/uL) | Drug | 1 |
Primary outcome
Objective absolute neutrophil count (ANC) response rate
Time frame: 18 Months
4 secondary outcomes
Incidence of infections, oropharyngeal ulcers and antibiotic use
Time frame: 18 Months
Incidence and duration of hospitalizations
Time frame: 18 Months
FACT-N quality of life assessment
Time frame: 18 Months
Safety assessments
Time frame: 18 Months
Results and safety
The study was stopped early (reason given: Study TLK199.2103 was terminated for business reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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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.
Gail Brown, MD study director
Telik
4 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 Ezatiostat Hydrochloride in people with Severe Chronic Neutropenia, run by Telik at 4 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 4 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: stopped early, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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: Study TLK199.2103 was terminated for business reasons.). 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?
Objective absolute neutrophil count (ANC) response rate (time frame: 18 Months). 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 25 Nov 2013.