NCT01459159

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.3 years

First QC Date

October 11, 2011

Last Update Submit

November 20, 2013

Conditions

Myelodysplastic Syndrome (MDS)

Keywords

HematologyMDSMyelodysplastic SyndromeLow risk MDSInt-1 risk MDSTransfusion dependenceTelintraezatiostatezatiostat hydrochlorideTLK199GlutathioneGlutathione analogGlutathione TransferaseGlutathione Transferase P1-1 inhibitorGST P1-1 inhibitorApoptosisDifferentiationEnzyme inhibitornon-del (5q)non-deletion 5q

Outcome Measures

Primary Outcomes (4)

  • Hematologic Improvement-Erythroid (HI-E) rate

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

    At 8 weeks of treatment

  • Hematologic Improvement-Erythroid (HI-E) rate

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

    At 16 weeks of treatment

  • Hematologic Improvement-Erythroid (HI-E) rate

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

    At 24 weeks of treatment

  • Hematologic Improvement-Erythroid (HI-E) rate

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

    At 32 weeks of treatment

Secondary Outcomes (8)

  • RBC Transfusion independence (TI) rate

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

  • Hematologic Improvement-Neutrophil (HI-N) rate

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

  • Hematologic Improvement-Platelet (HI-P) rate

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

  • Unilineage, bilineage, trilineage, and overall HI response rate

    2 years

  • Cytogenetic response rate

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

  • +3 more secondary outcomes

Interventions

ezatiostat hydrochloride (Telintra®)DRUG

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.

Also known as: Telintra, Telintra Tablets, Oral Telintra, ezatiostat, ezatiostat hydrochloride, oral ezatiostat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bay Area Cancer Research Group

Concord, California, 94520, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

SIU School of Medicine, Simmons Cancer Institute

Springfield, Illinois, 62794, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Columbia University

New York, New York, 10032, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

gamma-Glu-S-BzCys-PhGly diethyl ester

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Gail L Brown, MD

    Telik

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 25, 2011

Study Start

October 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

US(7)