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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)

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. Identifier: NCT01062152
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : June 6, 2013
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: Ezatiostat Hydrochloride Drug: Lenalidomide (Revlimid®) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Revlimid® in Combination with Telintra ®
Lenalidomide (Revlimid®) followed by Telintra® until MDS progression or lack of efficacy.
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.

Primary Outcome Measures :
  1. To establish the maximum tolerated dose (MTD) of ezatiostat in combination with lenalidomide [ Time Frame: 2 years ]
  2. To determine the safety of ezatiostat in combination with lenalidomide [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: 2 years ]
  3. Hematologic Improvement-Neutrophil (HI-N) rate [ Time Frame: 2 years ]
  4. Hematologic Improvement-Platelet (HI-P) rate [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.]

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 identifier (NCT number): NCT01062152

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United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, Illinois
Loyola University Chicago Cardinal Benardin Cancer Center
Maywood, Illinois, United States, 60153
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
Houston, Texas, United States, 77030
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
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Study Director: Gail Brown, M.D. Telik

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Telik Identifier: NCT01062152     History of Changes
Other Study ID Numbers: TLK199.1104
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: June 2013

Keywords provided by Telik:
Glutathione analog
Glutathione Transferase
Glutathione Transferase inhibitor
Glutathione Transferase P1-1 inhibitor
Myelodysplastic Syndrome
Low risk MDS
Patients with non-deletion(5q)
Non-deletion 5q
Non del(5q)
ezatiostat hydrochloride
GSTp1-1 inhibitor
Enzyme inhibitor

Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents