Text Size

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
  Purpose

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).


Condition Intervention Phase
Myelodysplastic Syndrome (MDS)
 Drug: ezatiostat hydrochloride (Telintra®)
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Telik:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 130
Study Start Date: August 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422486

Locations
United States, Illinois
Loyola University
Maywood, Illinois, United States, 60153
SIU School of Medicine, Simmons Cancer Center
Springfield, Illinois, United States, 62794-9677
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Telik
Investigators
Study Director: Gail L Brown, MD Telik
  More Information

No publications provided

Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT01422486     History of Changes
Other Study ID Numbers: TLK199.2107
Study First Received: August 18, 2011
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Telik:
Hematology
MDS
Myelodysplastic Syndrome
Low risk MDS
Intermediate-1 risk MDS
Int-1 risk MDS
Transfusion dependence
Lenalidomide refractory
Revlimid refractory
Lenalidomide resistant
Revlimid resistant
Telintra
 ezatiostat
ezatiostat hydrochloride
TLK199
Glutathione
Glutathione analog
Glutathione Transferase
Glutathione Transferase P1-1 inhibitor
GST P1-1 inhibitor
Apoptosis
Differentiation
Enzyme inhibitor

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
 Neoplasms
Lenalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013