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Dose-Ranging Study of Telintra® Tablets + Revlimid® in Patients With Non-Deletion (5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT01062152
First received: February 2, 2010
Last updated: June 4, 2013
Last verified: June 2013
History of Changes

February 2, 2010
June 4, 2013
November 2009
November 2012   (final data collection date for primary outcome measure)
  • To establish the maximum tolerated dose (MTD) of ezatiostat in combination with lenalidomide [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the safety of ezatiostat in combination with lenalidomide [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01062152 on ClinicalTrials.gov Archive Site
  • To determine the efficacy of ezatiosate in combination wiht lenalidomide in patients with non-del(5q) low to intermediate-1 risk of MDS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Hematologic Improvement-Neutrophil (HI-N) rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Hematologic Improvement-Platelet (HI-P) rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose-Ranging Study of Telintra® Tablets + Revlimid® in Patients With Non-Deletion (5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Phase 1 Dose-Ranging Study of Ezatiostat Hydrochloride (Telintra®, TLK199 Tablets)in Combination With Lenalidomide (Revlimid®)in Patients With Non-Deletion(5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

This is an open label, multicenter Phase 1 dose escalation study evaluating five doses of ezatiostat in combination with lenalidomide in patients with non-del(5q) low to intermediate 1 risk MDS. The HI-E, HI-N, HI-P rates [by International Working Group (IWG) 2006 criteria] and safety of each treatment group will be evaluated to select the optimal dose of ezatiostat in combination with lenalidomide for future studies.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelodysplastic Syndrome
  • Drug: Ezatiostat Hydrochloride
    Starting dose 2000 mg orally in divided doses twice daily (1000 mg in AM & 1000 mg in PM) x 21 days with one week off therapy in a 4-week cycle.
  • Drug: Lenalidomide (Revlimid®)
    10 mg orally per day in one AM dose x 21 days with one week off therapy in a 4-week cycle.
Experimental: Revlimid® in Combination with Telintra ®
Lenalidomide (Revlimid®) followed by Telintra® until MDS progression or lack of efficacy.
Interventions:
  • Drug: Ezatiostat Hydrochloride
  • Drug: Lenalidomide (Revlimid®)
Raza A, Galili N, Mulford D, Smith SE, Brown GL, Steensma DP, Lyons RM, Boccia R, Sekeres MA, Garcia-Manero G, Mesa RA. Phase 1 dose-ranging study of ezatiostat hydrochloride in combination with lenalidomide in patients with non-deletion (5q) low to intermediate-1 risk myelodysplastic syndrome (MDS). J Hematol Oncol. 2012 Apr 30;5:18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
March 2013
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologic diagnosis of primary or de novo MDS using WHO classification
  • Non-del(5q) low or Intermediate-1risk MDS
  • ECOG performance status of 0-1
  • Documented significant cytopenia for at least 2 months
  • Must have discontinued growth factors (EPO, G-CSF, GM-CSF) for at least 21 days prior to study entry
  • All study participants must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist®
  • Females of childbearing potential should have two negative serum pregnancy tests with a sensitivity of at least 50 mIU/mL. The first test should be performed within 10-14 days, and the second test within 24 hours of prescribing lenalidomide (prescriptions must be filled within seven days)

Exclusion Criteria:

  • Known hypersensitivity to Telintra™ (intravenous or oral)
  • Known prior therapy with or hypersensitivity to thalidomide or lenalidomide
  • Prior allogenic bone marrow transplant for MDS

  • History or prior malignancy

    • Except for treated carcinoma of uterine cervix, basal cell or squamous cell skin cancer, or other cancers (e.g. breast, prostate) for which patient has been disease-free for at least 3 years.

  • MDS evolving from:

    • A pre-existing myeloproliferative disorder
    • An autoimmune disease
    • Secondary to prior treatment with radiation or chemotherapy
  • History of MDS IPSS score>1.0
  • Pregnant or lactating women
  • Leptomeningeal or leukemic meningitis
  • Prior treatment with DNA methyltransferase inhibitors (DMTI) [e.g., azacitadine, decitabine, etc.]
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01062152
TLK199.1104
No
Telik
Telik
Not Provided
Study Director: Gail Brown, M.D. Telik
Telik
June 2013

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