Myelodysplastic Syndrome (MDS)Phase 2NCT00700206
Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
A Phase 2 study testing Ezatiostat Hydrochloride in people with Myelodysplastic Syndrome (MDS), run by Telik at 36 sites in United States.
Trial summary
This is a randomized, open label, multicenter, Phase 2 study comparing two dose schedules of Telintra in patients with Low or Intermediate-1 risk MDS. Patients at least 18 years of age presenting with histologically confirmed Low to Intermediate-1 risk MDS with documented significant cytopenia for at least two months… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome (MDS)
- 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
- 86 participants
- Where
- 36 sitesUnited States
- Study dates
- May 2008to Jul 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
- Primary or de novo MDS
- Low or intermediate-1 MDS
- ECOG performance status 0 or 1
- Documented significant anemia with or without neutropenia and/or thrombocytopenia
- Adequate kidney and liver function
- Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry
Who cannot join
- Prior allogenic bone marrow transplant for MDS
- History of MDS IPSS score greater than 1.0
- Pregnant or lactating women
- Any severe concurrent disease, infection, or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry
- Oral steroids e.g. prednisone >10 mg per day
- History of active hepatitis B or C
- Known history of HIV
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, 91801
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607
University of Colorado at Denver Health Sciences Center
Aurora, Colorado, 80445
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
The Center for Hematology Oncology
Boca Raton, Florida, 33486
Case Western Reserve University/University Hospitals of Cleveland
Cleveland, Ohio, 44106
Hematology & Medical Oncology
Cleveland, Ohio, 44195
St. Jude Heritage Healthcare
Fullerton, California, 92835
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052
MD Anderson Cancer Center
Houston, Texas, 77030
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, 60435
Wilshire Oncology Medical Group, Inc.
La Verne, California, 91750
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Suburban Hematology-Oncology Associates, P.C.
Lawrenceville, Georgia, 30045
UCLA Medical Center
Los Angeles, California, 90095
Loyola University Chicago
Maywood, Illinois, 60153
Clinical Trials and Research Associates, Inc.
Montebello, California, 90640
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
North Valley Hematology/Oncology Medical Group
Northridge, California, 91325
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Cancer Care Associates
Oklahoma City, Oklahoma, 73112
Bay Area Cancer Research Group
Pleasant Hill, California, 94523
Kaiser Permanente
Portland, Oregon, 97227
Desert Hematology Oncology Medical Group
Rancho Mirage, California, 92270
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 92077
University of Rochester Medical Center
Rochester, New York, 14642
Cancer Care Centers of South Texas
San Antonio, Texas, 78229
Sansum Clinic
Santa Barbara, California, 93105
Santa Barbara Hematology Medical Group, Inc.
Santa Barbara, California, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Moffitt Cancer Center
Tampa, Florida, 33612
Central Hematology Oncology Medical Group, Inc.
Terre Haute, Indiana, 47802
Arizona Cancer Center
Tucson, Arizona, 85724-5024
Cancer Care Associates
Tulsa, Oklahoma, 74136
About this study
Official title: Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
This is a randomized, open label, multicenter, Phase 2 study comparing two dose schedules of Telintra in patients with Low or Intermediate-1 risk MDS. Patients at least 18 years of age presenting with histologically confirmed Low to Intermediate-1 risk MDS with documented significant cytopenia for at least two months by the IWG criteria are eligible.
- Conditions
- Myelodysplastic Syndrome (MDS)
- Being tested
- Ezatiostat Hydrochloride
- Keywords
- Hematology, MDS, Myelodysplastic Syndrome, Low Risk MDS, Intermediate-1 risk MDS, Int-1 risk MDS, 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
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezatiostat HydrochlorideDrug
Also called Telintra, ezatiostat tablets
Dose Schedule 1-3000 mg orally per day in two divided doses for two weeks followed by 1 week with no treatment per three week cycle.
Dose Schedule 2-2000 mg orally per day in two divided doses for three weeks followed by 1 week with no treatment per four week cycle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose Schedule 1: Two weeks treatment with Telintra 3000 mg per day in two divided doses followed by one week with no treatment per three week cycle. Receives: Drug: Ezatiostat Hydrochloride |
| 2 | Experimental | Dose Schedule 2: Three weeks treatment with Telintra 2000 mg per day in two divided doses followed by one week with no treatment per four week cycle. Receives: Drug: Ezatiostat Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic Improvement-Erythroid (HI-E) rate
Measured: 24 Weeks
Secondary outcomes (1)
Hematologic Improvement-Neutrophil (HI-N) rate, the Hematologic Improvement-Platelet (HI-P) rate, overall hematologic response rate, safety profile and Quality of Life assessments.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndrome (MDS)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
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
- NCT00700206
- Sponsor's protocol ID
- TLK199.2101
- Status last verified
- Aug 2011
- First submitted
- 13 Jun 2008
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT00700206
- Acronym / sponsor ID
- TLK199.2101
- Conditions
- Myelodysplastic Syndrome (MDS)
- Keywords
- Hematology, MDS, Myelodysplastic Syndrome, Low Risk MDS, Intermediate-1 risk MDS, Int-1 risk MDS, Telintra, ezatiostat hydrochloride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- TelikIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Jun 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.
This is a randomized, open label, multicenter, Phase 2 study comparing two dose schedules of Telintra in patients with Low or Intermediate-1 risk MDS. Patients at least 18 years of age presenting with histologically confirmed Low to Intermediate-1 risk MDS with documented significant cytopenia for at least two months by the IWG criteria are eligible.
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 HydrochlorideDose Schedule 1: Two weeks treatment with Telintra 3000 mg per day in two divided doses followed by one week with no treatment per three week cycle. |
| 2 | Experimental | Drug: Ezatiostat HydrochlorideDose Schedule 2: Three weeks treatment with Telintra 2000 mg per day in two divided doses followed by one week with no treatment per four week cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary or de novo MDS
- Low or intermediate-1 MDS
- ECOG performance status 0 or 1
- Documented significant anemia with or without neutropenia and/or thrombocytopenia
- Adequate kidney and liver function
Key exclusion criteria (7 listed)
- Prior allogenic bone marrow transplant for MDS
- History of MDS IPSS score greater than 1.0
- Pregnant or lactating women
- Any severe concurrent disease, infection, or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry
- Oral steroids e.g. prednisone >10 mg per day
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, ezatiostat tabletsDose Schedule 1-3000 mg orally per day in two divided doses for two weeks followed by 1 week with no treatment per three week cycle. Dose Schedule 2-2000 mg orally per day in two divided doses for three weeks followed by 1 week with no treatment per four week cycle. | Drug | 1, 2 |
Primary outcome
Hematologic Improvement-Erythroid (HI-E) rate
Time frame: 24 Weeks
1 secondary outcome
Hematologic Improvement-Neutrophil (HI-N) rate, the Hematologic Improvement-Platelet (HI-P) rate, overall hematologic response rate, safety profile and Quality of Life assessments.
Time frame: 24 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 12 Oct 2011.
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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
36 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 Myelodysplastic Syndrome (MDS), run by Telik at 36 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 6 inclusion and 7 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 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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 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?
Hematologic Improvement-Erythroid (HI-E) rate (time frame: 24 Weeks). 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 12 Oct 2011.