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

This study has been terminated.
(Study TLK199.2108 was terminated for business reasons.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01459159
First Posted: October 25, 2011
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Telik
October 11, 2011
October 25, 2011
November 25, 2013
October 2011
February 2013   (Final data collection date for primary outcome measure)
  • Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 8 weeks of treatment ]
    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 ]
    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 ]
    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 ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Same as current
Complete list of historical versions of study NCT01459159 on ClinicalTrials.gov Archive Site
  • RBC Transfusion independence (TI) rate [ Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment ]
  • Hematologic Improvement-Neutrophil (HI-N) rate [ Time Frame: At 8, 16, 24, & 32 weeks of treatment ]
    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 ]
    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 ]
  • Cytogenetic response rate [ Time Frame: 16 weeks, 48 weeks and at the time of first HI response ]
  • Duration of response [ Time Frame: 2 years ]
  • Safety of ezatiostat in this MDS population [ Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment ]
    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 ]
Same as current
Not Provided
Not Provided
 
Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome
Phase 2b Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Low to Intermediate-1 Risk, Non-Deletion 5q Myelodysplastic Syndrome
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).
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myelodysplastic Syndrome (MDS)
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
  • Telintra Tablets
  • Oral Telintra
  • ezatiostat
  • ezatiostat hydrochloride
  • oral ezatiostat
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
162
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01459159
TLK199.2108
No
Not Provided
Not Provided
Telik
Telik
Not Provided
Study Director: Gail L Brown, MD Telik
Telik
November 2013

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