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Myelodysplastic Syndrome (MDS)Phase 2NCT01459159

Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome

A Phase 2 study testing ezatiostat hydrochloride (Telintra®) in people with Myelodysplastic Syndrome (MDS), run by Telik at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®) in Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q) Myelodysplastic Syndrome (MDS). 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 (Telintra®)
Type of treatment
Pill or oral medicine
How many people
162 participants
Where
7 sitesUnited States
Study dates
Oct 2011to Feb 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

  • Primary or de Novo MDS
  • Low to Intermediate-1 IPSS risk of MDS
  • ECOG performance score of 0 or 1
  • Documentation of significant anemia with or without additional cytopenia
  • Adequate kidney and liver function
  • Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry

Who cannot join

  • Deletion of the 5q chromosome [del(5q) MDS]
  • Prior allogenic bone marrow transplant for MDS
  • Known sensitivity to ezatiostat (injection or oral tablets)
  • Prior treatment with hypomethylating agent (HMA) (e.g., azacitadine, decitabine)
  • History of MDS IPSS risk score of greater than 1.0
  • Pregnant or lactating women
Show all 9Show fewer
  • Any severe concurrent disease, infection or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry
  • Oral steroids greater than 10 mg per day. Exceptions: those prescribed for other conditions (such as new adrenal failure, asthma, arthritis) or brief sterioid use (such as tapered dosing for an acute non-MDS condition)
  • History of hepatitis B or C, or HIV

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Bay Area Cancer Research Group

    Concord, California, 94520

  • The West Clinic

    Memphis, Tennessee, 38120

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Columbia University

    New York, New York, 10032

  • SIU School of Medicine, Simmons Cancer Institute

    Springfield, Illinois, 62794

Other trials in United States

About this study

Official title: Phase 2b Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Low to Intermediate-1 Risk, Non-Deletion 5q Myelodysplastic Syndrome

This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®) in Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q) Myelodysplastic Syndrome (MDS).

Being tested
ezatiostat hydrochloride (Telintra®)
Keywords
Hematology, MDS, Myelodysplastic Syndrome, Low risk MDS, Int-1 risk MDS, Transfusion dependence, Telintra, ezatiostat, ezatiostat hydrochloride, TLK199, Glutathione, Glutathione analog, Glutathione Transferase, Glutathione Transferase P1-1 inhibitor, GST P1-1 inhibitor, Apoptosis, Differentiation, Enzyme inhibitor, non-del (5q), non-deletion 5q
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 hydrochloride (Telintra®)Drug

    Also called Telintra, Telintra Tablets, Oral Telintra, ezatiostat

    Three weeks of treatment with ezatiostat at 2000 mg per day in divided doses followed by a one week rest period in four-week treatment cycles.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematologic Improvement-Erythroid (HI-E) rate

    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

    Measured: At 8 weeks of treatment

  2. Hematologic Improvement-Erythroid (HI-E) rate

    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

    Measured: At 16 weeks of treatment

  3. Hematologic Improvement-Erythroid (HI-E) rate

    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

    Measured: At 24 weeks of treatment

  4. Hematologic Improvement-Erythroid (HI-E) rate

    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

    Measured: At 32 weeks of treatment

Secondary outcomes (8)

  1. RBC Transfusion independence (TI) rate

    Measured: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment

  2. Hematologic Improvement-Neutrophil (HI-N) rate

    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

    Measured: At 8, 16, 24, & 32 weeks of treatment

  3. Hematologic Improvement-Platelet (HI-P) rate

    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

    Measured: At 8, 16, 24, & 32 weeks of treatment

  4. Unilineage, bilineage, trilineage, and overall HI response rate

    Measured: 2 years

  5. Cytogenetic response rate

    Measured: 16 weeks, 48 weeks and at the time of first HI response

  6. Duration of response

    Measured: 2 years

  7. Safety of ezatiostat in this MDS population

    Recording and grading of AEs using NCI-CTCAE v4.03

    Measured: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment

  8. Evaluation of the relationship between HI-E response, gene expression profiling and response-related variables

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Why it stopped: Study TLK199.2108 was terminated for business reasons.

Resources

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
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01459159
Sponsor's protocol ID
TLK199.2108
Status last verified
Nov 2013
First submitted
11 Oct 2011
Last updated
25 Nov 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ezatiostat hydrochloride (Telintra®) in people with Myelodysplastic Syndrome (MDS), run by Telik at 7 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 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: 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 7 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 TLK199.2108 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?

Hematologic Improvement-Erythroid (HI-E) rate (time frame: At 8 weeks of treatment). The study lists 4 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 NCT01459159.

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.

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