Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome

November 20, 2013 updated by: Telik

Phase 2 Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Lenalidomide (Revlimid®) Refractory or Resistant, Low to Intermediate-1 Risk, Deletion 5q Myelodysplastic Syndrome

Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic Syndrome (MDS).

Study Overview

Status

Terminated

Detailed Description

Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic Syndrome (MDS). Independence from red blood cell transfusions, improvement in the levels of red blood cells, white blood cells, and platelets, and the response of the bone marrow were evaluated. Patients received a starting dose of 2000 mg total daily dose in divided doses (1000 mg orally twice daily for three weeks (21 days) on therapy followed by a one-week (7 days) off therapy rest period in four-week (28 days) treatment cycles. Patients continued treatment until documentation of lack of MDS response, MDS progression, unacceptable toxicity, or patient withdrawal from the study.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University
      • Springfield, Illinois, United States, 62794-9677
        • SIU School of Medicine, Simmons Cancer Center
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center For Cancer and Blood Disorders
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary or de Novo MDS
  • Low or Intermediate-1 IPSS risk MDS
  • Deletion of the 5q chromosome [del(5q) MDS]
  • Refractory or resistant to lenalidomide (Revlimid)
  • 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

Exclusion Criteria:

  • 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
  • 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 steroid use (such as tapered dosing for an acute non-MDS condition)
  • History of hepatitis B or C, or HIV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ezatiostat hydrochloride (Telintra®)
Patients received ezatiostat at a starting dose of 2000 mg total daily dose in divided doses (1000 mg PO b.i.d.) for three weeks (21 days) on therapy followed by a one-week (7 days) off therapy rest period in four-week (28 days) treatment cycles.
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.
Other Names:
  • Telintra
  • Telinta Tablets
  • Oral Telintra
  • ezatiostat
  • ezatiostat hydrochloride
  • oral ezatiostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematologic Improvement-Erythroid (HI-E) rate
Time Frame: At 8, 16, 24, and 32 weeks of treatment
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
At 8, 16, 24, and 32 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response
Time Frame: 2 years
2 years
RBC Transfusion independence (TI) rate
Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment
At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment
Hematologic Improvement-Neutrophil (HI-N) rate
Time Frame: At 8, 16, 24, & 32 weeks of treatment
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
At 8, 16, 24, & 32 weeks of treatment
Hematologic Improvement-Platelet (HI-P) rate
Time Frame: At 8, 16, 24, & 32 weeks of treatment
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
At 8, 16, 24, & 32 weeks of treatment
Unilineage, bilineage, trilineage, and overall HI response rate
Time Frame: 2 years
2 years
Cytogenetic response rate
Time Frame: 16 weeks, 48 weeks and at the time of first HI response
16 weeks, 48 weeks and at the time of first HI response
Safety of ezatiostat in this MDS population
Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment
Recording and grading of AEs using NCI-CTCAE v4.03
At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment
Evaluation of the relationship between HI-E response, gene expression profiling and response-related variables
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Gail L Brown, MD, Telik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 22, 2011

First Posted (ESTIMATE)

August 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 20, 2013

Last Verified

November 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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