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

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.
 
ClinicalTrials.gov Identifier: NCT01422486
Recruitment Status : Terminated (Study TLK199.2107 was terminated for business reasons.)
First Posted : August 24, 2011
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Telik

Study Description
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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).

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome (MDS) Drug: ezatiostat hydrochloride (Telintra®) Phase 2

Detailed Description:
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). Independence from red blood cell transfusions, improvement in the levels of red blood cells, white blood cells, and platelets, and the response of the bone marrow were evaluated. Patients received a starting dose of 2000 mg total daily dose in divided doses (1000 mg orally twice daily 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. Patients continued treatment until documentation of lack of MDS response, MDS progression, unacceptable toxicity, or patient withdrawal from the study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ezatiostat hydrochloride (Telintra®)
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®)
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


Outcome Measures
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Primary Outcome Measures :
  1. Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 8, 16, 24, and 32 weeks of treatment ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)


Secondary Outcome Measures :
  1. RBC Transfusion independence (TI) rate [ Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment ]
  2. 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)

  3. 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)

  4. Unilineage, bilineage, trilineage, and overall HI response rate [ Time Frame: 2 years ]
  5. Cytogenetic response rate [ Time Frame: 16 weeks, 48 weeks and at the time of first HI response ]
  6. Duration of response [ Time Frame: 2 years ]
  7. 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

  8. Evaluation of the relationship between HI-E response, gene expression profiling and response-related variables [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422486


Locations
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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
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Study Director: Gail L Brown, MD Telik
More Information
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Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT01422486    
Other Study ID Numbers: TLK199.2107
First Posted: August 24, 2011    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
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:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
 Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms