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

Primary Purpose

Myelodysplastic Syndrome (MDS)

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ezatiostat hydrochloride (Telintra®)

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome (MDS) focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Bay Area Cancer Research Group
University of Colorado
SIU School of Medicine, Simmons Cancer Institute
Center for Cancer and Blood Disorders
Columbia University
The West Clinic
Vanderbilt University

Outcomes

Primary Outcome Measures

Hematologic Improvement-Erythroid (HI-E) rate

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

Hematologic Improvement-Erythroid (HI-E) rate

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

Hematologic Improvement-Erythroid (HI-E) rate

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

Hematologic Improvement-Erythroid (HI-E) rate

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

Secondary Outcome Measures

RBC Transfusion independence (TI) rate

Hematologic Improvement-Neutrophil (HI-N) rate

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

Hematologic Improvement-Platelet (HI-P) rate

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

Unilineage, bilineage, trilineage, and overall HI response rate

Cytogenetic response rate

Duration of response

Safety of ezatiostat in this MDS population

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

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

Full Information

NCT ID

NCT01459159

First Posted

October 11, 2011

Last Updated

November 20, 2013

Sponsor

Telik

1. Study Identification

Unique Protocol Identification Number

NCT01459159

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Terminated

Why Stopped

Study TLK199.2108 was terminated for business reasons.

Study Start Date

October 2011 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Telik

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelodysplastic Syndrome (MDS)

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

162 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ezatiostat hydrochloride (Telintra®)

Other Intervention Name(s)

Telintra, Telintra Tablets, Oral Telintra, ezatiostat, ezatiostat hydrochloride, oral ezatiostat

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hematologic Improvement-Erythroid (HI-E) rate

Description

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

Time Frame

At 8 weeks of treatment

Title

Hematologic Improvement-Erythroid (HI-E) rate

Description

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

Time Frame

At 16 weeks of treatment

Title

Hematologic Improvement-Erythroid (HI-E) rate

Description

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

Time Frame

At 24 weeks of treatment

Title

Hematologic Improvement-Erythroid (HI-E) rate

Description

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

Time Frame

At 32 weeks of treatment

Secondary Outcome Measure Information:

Title

RBC Transfusion independence (TI) rate

Time Frame

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

Title

Hematologic Improvement-Neutrophil (HI-N) rate

Description

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

Time Frame

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

Title

Hematologic Improvement-Platelet (HI-P) rate

Description

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

Time Frame

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

Title

Unilineage, bilineage, trilineage, and overall HI response rate

Time Frame

2 years

Title

Cytogenetic response rate

Time Frame

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

Title

Duration of response

Time Frame

2 years

Title

Safety of ezatiostat in this MDS population

Description

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

Time Frame

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

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gail L Brown, MD

Organizational Affiliation

Telik

Official's Role

Study Director

Facility Information:

Facility Name

Bay Area Cancer Research Group

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

University of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

SIU School of Medicine, Simmons Cancer Institute

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62794

Country

United States

Facility Name

Center for Cancer and Blood Disorders

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

The West Clinic

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

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

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