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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Telik

ClinicalTrials.gov Identifier:

NCT01422486

First received: August 18, 2011

Last updated: March 13, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 18, 2011

Last Updated Date

March 13, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 8 weeks of treatment ] [ Designated as safety issue: No ]
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 16 weeks of treatment ] [ Designated as safety issue: No ]
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 24 weeks of treatment ] [ Designated as safety issue: No ]
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 32 weeks of treatment ] [ Designated as safety issue: No ]
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

Original Primary Outcome Measures ^ICMJE

Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

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

Change History

Complete list of historical versions of study NCT01422486 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

RBC Transfusion independence (TI) rate [ Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment ] [ Designated as safety issue: No ]
Hematologic Improvement-Neutrophil (HI-N) rate [ Time Frame: At 8, 16, 24, & 32 weeks of treatment ] [ Designated as safety issue: No ]
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Hematologic Improvement-Platelet (HI-P) rate [ Time Frame: At 8, 16, 24, & 32 weeks of treatment ] [ Designated as safety issue: No ]
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Unilineage, bilineage, trilineage, and overall HI response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Cytogenetic response rate [ Time Frame: 16 weeks, 48 weeks and at the time of first HI response ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Safety of ezatiostat in this MDS population [ Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

RBC Transfusion independence (TI) rate [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
Hematologic Improvement-Neutrophil (HI-N) rate [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Hematologic Improvement-Platelet (HI-P) rate [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Unilineage, bilineage, trilineage, and overall HI response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Cytogenetic response rate [ Time Frame: 16 weeks, 48 weeks and at the time of first HI response ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Safety of ezatiostat in this MDS population [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

This 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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Myelodysplastic Syndrome (MDS)

Intervention ^ICMJE

Drug: ezatiostat hydrochloride (Telintra®)

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

130

Estimated Completion Date

October 2013

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01422486

Other Study ID Numbers ^ICMJE

TLK199.2107

Has Data Monitoring Committee

Responsible Party

Telik

Study Sponsor ^ICMJE

Telik

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Gail L Brown, MD

Telik

Information Provided By

Telik

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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