NCT01422486

Brief Summary

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).

Trial Health

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Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 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

August 18, 2011

Last Update Submit

November 20, 2013

Conditions

Myelodysplastic Syndrome (MDS)

Keywords

HematologyMDSMyelodysplastic SyndromeLow risk MDSIntermediate-1 risk MDSInt-1 risk MDSTransfusion dependenceLenalidomide refractoryRevlimid refractoryLenalidomide resistantRevlimid resistantTelintraezatiostatezatiostat hydrochlorideTLK199GlutathioneGlutathione analogGlutathione TransferaseGlutathione Transferase P1-1 inhibitorGST P1-1 inhibitorApoptosisDifferentiationEnzyme inhibitor

Outcome Measures

Primary Outcomes (1)

  • Hematologic Improvement-Erythroid (HI-E) rate

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

    At 8, 16, 24, and 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

Study Arms (1)

ezatiostat hydrochloride (Telintra®)

EXPERIMENTAL

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.

Drug: ezatiostat hydrochloride (Telintra®)

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, Telinta Tablets, Oral Telintra, ezatiostat, ezatiostat hydrochloride, oral ezatiostat
ezatiostat hydrochloride (Telintra®)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Loyola University

Maywood, Illinois, 60153, United States

Location

SIU School of Medicine, Simmons Cancer Center

Springfield, Illinois, 62794-9677, 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

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2011

First Posted

August 24, 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(5)