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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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).

Detailed 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). 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.
Sponsor: Telik

Current Primary Outcome: 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)


Original Primary Outcome: Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: Every 8 weeks ]

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


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • RBC Transfusion independence (TI) rate [ Time Frame: Every 4 weeks ]
  • Hematologic Improvement-Neutrophil (HI-N) rate [ Time Frame: Every 8 weeks ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
  • Hematologic Improvement-Platelet (HI-P) rate [ Time Frame: Every 8 weeks ]
    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: Every 4 weeks ]
    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 ]


Information By: Telik

Dates:
Date Received: August 18, 2011
Date Started: October 2011
Date Completion:
Last Updated: November 20, 2013
Last Verified: November 2013