Brief Summary

This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or enter an observation period with an option to crossover to Telintra treatment in a 1:1 allocation.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Apr 2009

Typical duration for phase_2

Geographic Reach

1 country

4 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

4.1 years study duration

Study Start

First participant enrolled

April 1, 2009

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2009

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2009

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed

Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

4.1 years

First QC Date

May 26, 2009

Last Update Submit

November 20, 2013

Conditions

Severe Chronic Neutropenia

Keywords

HematologyNeutropeniaSCNSevere Chronic NeutropeniaIdiopathicTelintraezatiostat hydrochlorideezatiostatTLK199GlutathioneGlutathione analogGlutathione TransferaseGlutathione Transferase inhibitorGlutathione Transferase P1-1 inhibitorGSTp1-1 inhibitorApoptosisDifferentiationEnzyme inhibitor

Outcome Measures

Primary Outcomes (1)

Objective absolute neutrophil count (ANC) response rate
18 Months

Secondary Outcomes (4)

Incidence of infections, oropharyngeal ulcers and antibiotic use
18 Months
Incidence and duration of hospitalizations
18 Months
FACT-N quality of life assessment
18 Months
Safety assessments
18 Months

Study Arms (2)

1

EXPERIMENTAL

4-Week dose equilibration period with Telintra followed by 4 month treatment period

Drug: Ezatiostat Hydrochloride

2

NO INTERVENTION

4 Month observation period with standard of care treatment and option to crossover to Telintra treatment for 4 week dose equilibration followed by 4 week treatment period

Interventions

Ezatiostat HydrochlorideDRUG

Starting Dose 2000 mg orally per day in two divided doses with dose to increase or decrease to achieve target median ANC (Range 1,500-10,000 cells/uL)

Also known as: Telintra tablets, TLK199 Tablets

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Confirmed Idiopathic Severe Chronic Neutropenia
ECOG performance status of 0-2
Adequate liver and renal function
Adequate Red Blood Cell and Platelet counts

You may not qualify if:

Prior treatment of SCN
Non-Idiopathic types of SCN, ie. cyclic, congenital
History of chromosomal abnormalities, myelodysplasia, hematologic malignancy, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis (Felty's syndrome), or other collagen diseases, and drug-induced neutropenia, autoimmune neutropenia
Use of granulocyte colony stimulating factors (G-CSF), glucocorticoids, gamma globulin, lithium or investigational drug(s) within one month of enrollment
History of bone marrow transplantation or stem cell support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Teliklead

Study Sites (4)

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109-0238, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78229, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Neutropenia, severe chronicNeutropenia

Interventions

gamma-Glu-S-BzCys-PhGly diethyl ester

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

Gail Brown, MD
Telik
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 26, 2009

First Posted

May 28, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

US(4)

Study Stopped

Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations