Myelodysplastic SyndromePhase 1NCT01062152
Dose-Ranging Study of Telintra® Tablets + Revlimid® in Patients With Non-Deletion (5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
A Phase 1 study testing Ezatiostat Hydrochloride and Lenalidomide (Revlimid®) in people with Myelodysplastic Syndrome, run by Telik at 9 sites in United States.
Trial summary
This is an open label, multicenter Phase 1 dose escalation study evaluating five doses of ezatiostat in combination with lenalidomide in patients with non-del(5q) low to intermediate 1 risk MDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- Ezatiostat Hydrochloride and Lenalidomide (Revlimid®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2009to Mar 2013
- Phase
- Phase 1
- 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
- Histologic diagnosis of primary or de novo MDS using WHO classification
- Non-del(5q) low or Intermediate-1risk MDS
- ECOG performance status of 0-1
- Documented significant cytopenia for at least 2 months
- Must have discontinued growth factors (EPO, G-CSF, GM-CSF) for at least 21 days prior to study entry
- All study participants must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist®
- Females of childbearing potential should have two negative serum pregnancy tests with a sensitivity of at least 50 mIU/mL. The first test should be performed within 10-14 days, and the second test within 24 hours of prescribing lenalidomide (prescriptions must be filled within seven days)
Who cannot join
- Known hypersensitivity to Telintra™ (intravenous or oral)
- Known prior therapy with or hypersensitivity to thalidomide or lenalidomide
- Prior allogenic bone marrow transplant for MDS
- History or prior malignancy
- Except for treated carcinoma of uterine cervix, basal cell or squamous cell skin cancer, or other cancers (e.g. breast, prostate) for which patient has been disease-free for at least 3 years.
- MDS evolving from:
Show all 13Show fewer
- A pre-existing myeloproliferative disorder
- An autoimmune disease
- Secondary to prior treatment with radiation or chemotherapy
- History of MDS IPSS score>1.0
- Pregnant or lactating women
- Leptomeningeal or leukemic meningitis
- Prior treatment with DNA methyltransferase inhibitors (DMTI) [e.g., azacitadine, decitabine, etc.]
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
MDAnderson
Houston, Texas, 77030
Loyola University Chicago Cardinal Benardin Cancer Center
Maywood, Illinois, 60153
Columbia University Medical Center
New York, New York, 10032
Mayo Clinic
Phoenix, Arizona, 85054
University of Rochester Medical Center
Rochester, New York, 14642
Cancer Care Centers of South Texas
San Antonio, Texas, 78229
About this study
Official title: Phase 1 Dose-Ranging Study of Ezatiostat Hydrochloride (Telintra®, TLK199 Tablets)in Combination With Lenalidomide (Revlimid®)in Patients With Non-Deletion(5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
This is an open label, multicenter Phase 1 dose escalation study evaluating five doses of ezatiostat in combination with lenalidomide in patients with non-del(5q) low to intermediate 1 risk MDS. The HI-E, HI-N, HI-P rates [by International Working Group (IWG) 2006 criteria] and safety of each treatment group will be evaluated to select the optimal dose of ezatiostat in combination with lenalidomide for future studies.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- Ezatiostat Hydrochloride, Lenalidomide (Revlimid®)
- Keywords
- Hematology, MDS, Myelodysplastic Syndrome, Low risk MDS, Patients with non-deletion(5q), Non-deletion 5q, Non del(5q), Revlimid, lenalidomide, Telintra, ezatiostat hydrochloride, ezatiostat, TLK199, Glutathione, Glutathione analog, Glutathione Transferase, Glutathione Transferase inhibitor, Glutathione Transferase P1-1 inhibitor, GSTp1-1 inhibitor, Apoptosis
- 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
Starting dose 2000 mg orally in divided doses twice daily (1000 mg in AM \& 1000 mg in PM) x 21 days with one week off therapy in a 4-week cycle.
Lenalidomide (Revlimid®)Drug
10 mg orally per day in one AM dose x 21 days with one week off therapy in a 4-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Revlimid® in Combination with Telintra ® | Experimental | Lenalidomide (Revlimid®) followed by Telintra® until MDS progression or lack of efficacy. Receives: Drug: Ezatiostat Hydrochloride; Drug: Lenalidomide (Revlimid®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the maximum tolerated dose (MTD) of ezatiostat in combination with lenalidomide
Measured: 2 years
To determine the safety of ezatiostat in combination with lenalidomide
Measured: 2 years
Secondary outcomes (4)
To determine the efficacy of ezatiosate in combination wiht lenalidomide in patients with non-del(5q) low to intermediate-1 risk of MDS
Measured: 2 years
Hematologic Improvement-Erythroid (HI-E) rate
Measured: 2 years
Hematologic Improvement-Neutrophil (HI-N) rate
Measured: 2 years
Hematologic Improvement-Platelet (HI-P) rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2012
- Study completionMar 2013
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 Myelodysplastic SyndromeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telik
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Brown, M.D., Study director, Telik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062152
- Sponsor's protocol ID
- TLK199.1104
- Status last verified
- Jun 2013
- First submitted
- 2 Feb 2010
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Raza A, Galili N, Mulford D, Smith SE, Brown GL, Steensma DP, Lyons RM, Boccia R, Sekeres MA, Garcia-Manero G, Mesa RA. Phase 1 dose-ranging study of ezatiostat hydrochloride in combination with lenalidomide in patients with non-deletion (5q) low to intermediate-1 risk myelodysplastic syndrome (MDS). J Hematol Oncol. 2012 Apr 30;5:18. doi: 10.1186/1756-8722-5-18.
PubMed 22546242
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose-Ranging Study of Ezatiostat Hydrochloride (Telintra®, TLK199 Tablets)in Combination With Lenalidomide (Revlimid®)in Patients With Non-Deletion(5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT01062152
- Acronym / sponsor ID
- TLK199.1104
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Hematology, MDS, Myelodysplastic Syndrome, Low risk MDS, Patients with non-deletion(5q), Non-deletion 5q, Non del(5q), Revlimid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- TelikIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Feb 2010 (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 an open label, multicenter Phase 1 dose escalation study evaluating five doses of ezatiostat in combination with lenalidomide in patients with non-del(5q) low to intermediate 1 risk MDS. The HI-E, HI-N, HI-P rates [by International Working Group (IWG) 2006 criteria] and safety of each treatment group will be evaluated to select the optimal dose of ezatiostat in combination with lenalidomide for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revlimid® in Combination with Telintra ® | Experimental | Drug: Ezatiostat Hydrochloride, Drug: Lenalidomide (Revlimid®)Lenalidomide (Revlimid®) followed by Telintra® until MDS progression or lack of efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologic diagnosis of primary or de novo MDS using WHO classification
- Non-del(5q) low or Intermediate-1risk MDS
- ECOG performance status of 0-1
- Documented significant cytopenia for at least 2 months
- Must have discontinued growth factors (EPO, G-CSF, GM-CSF) for at least 21 days prior to study entry
Key exclusion criteria (13 listed)
- Known hypersensitivity to Telintra™ (intravenous or oral)
- Known prior therapy with or hypersensitivity to thalidomide or lenalidomide
- Prior allogenic bone marrow transplant for MDS
- History or prior malignancy
- MDS evolving from:
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 HydrochlorideStarting dose 2000 mg orally in divided doses twice daily (1000 mg in AM \& 1000 mg in PM) x 21 days with one week off therapy in a 4-week cycle. | Drug | Revlimid® in Combination with Telintra ® |
| Lenalidomide (Revlimid®)10 mg orally per day in one AM dose x 21 days with one week off therapy in a 4-week cycle. | Drug | Revlimid® in Combination with Telintra ® |
Primary outcome
To establish the maximum tolerated dose (MTD) of ezatiostat in combination with lenalidomide
Time frame: 2 years
To determine the safety of ezatiostat in combination with lenalidomide
Time frame: 2 years
4 secondary outcomes
To determine the efficacy of ezatiosate in combination wiht lenalidomide in patients with non-del(5q) low to intermediate-1 risk of MDS
Time frame: 2 years
Hematologic Improvement-Erythroid (HI-E) rate
Time frame: 2 years
Hematologic Improvement-Neutrophil (HI-N) rate
Time frame: 2 years
Hematologic Improvement-Platelet (HI-P) rate
Time frame: 2 years
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 6 Jun 2013.
- Derived from this study: PubMed 22546242Raza A, Galili N, Mulford D, Smith SE, Brown GL, Steensma DP, Lyons RM, Boccia R, Sekeres MA, Garcia-Manero G, Mesa RA. Phase 1 dose-ranging study of ezatiostat hydrochloride in combination with lenalidomide in patients with non-deletion (5q) low to intermediate-1 risk myelodysplastic syndrome (MDS). J Hematol Oncol. 2012 Apr 30;5:18. doi: 10.1186/1756-8722-5-18.
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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, M.D. study director
Telik
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ezatiostat Hydrochloride and Lenalidomide (Revlimid®) in people with Myelodysplastic Syndrome, run by Telik at 9 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 7 inclusion and 13 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 6 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To establish the maximum tolerated dose (MTD) of ezatiostat in combination with lenalidomide (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT01062152, 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 6 Jun 2013.