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Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome (MDS)

Thank you

Trial Information

Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)


Inclusion Criteria:



- Primary or de novo MDS

- Low or intermediate-1 MDS

- ECOG performance status 0 or 1

- Documented significant anemia with or without neutropenia and/or
thrombocytopenia

- 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

- History of MDS IPSS score 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 e.g. prednisone >10 mg per day

- History of active hepatitis B or C

- Known history of HIV

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Hematologic Improvement-Erythroid (HI-E) rate

Outcome Time Frame:

24 Weeks

Safety Issue:

No

Principal Investigator

Gail Brown, MD

Investigator Role:

Study Director

Investigator Affiliation:

Telik

Authority:

United States: Food and Drug Administration

Study ID:

TLK199.2101

NCT ID:

NCT00700206

Start Date:

May 2008

Completion Date:

July 2011

Related Keywords:

  • Myelodysplastic Syndrome (MDS)
  • Hematology
  • MDS
  • Myelodysplastic Syndrome
  • Low Risk MDS
  • Intermediate-1 risk MDS
  • Int-1 risk MDS
  • Telintra
  • ezatiostat hydrochloride
  • ezatiostat
  • TLK199
  • Glutathione
  • Glutathione analog
  • Glutathione Transferase
  • Glutathione Transferase inhibitor
  • Glutathione Transferase P1-1 inhibitor
  • GSTp1-1 inhibitor
  • Apoptosis
  • Differentiation
  • Enzyme inhibitor
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Rochester Medical CenterRochester, New York  14642
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Wilshire Oncology Medical Group, Inc.Rancho Cucamonga, California  91730
St. Vincent's Comprehensive Cancer CenterNew York, New York  10011
Cancer Care AssociatesTulsa, Oklahoma  74136
UCLA Medical CenterLos Angeles, California  90095-7059
Lakeland Regional Cancer CenterLakeland, Florida  33805
Northeast Georgia Cancer Care, LLCAthens, Georgia  30607
North Valley Hematology/Oncology Medical GroupNorthridge, California  91328
Cancer Care Associates Medical Group, Inc.Torrance, California  90505
Moffitt Cancer CenterTampa, Florida  33612
Bay Area Cancer Research GroupConcord, California  94520
Kaiser PermanentePortland, Oregon  97227
The University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Joliet Oncology-Hematology Associates, Ltd.Flossmoor, Illinois  60422
Center for Cancer and Blood DisordersBethesda, Maryland  20817
The Center for Hematology OncologyBoca Raton, Florida  33486
Clinical Trials and Research Associates, Inc.Montebello, California  60460
Central Hematology Oncology Medical Group, Inc.Alhambra, California  91801
Desert Hematology Oncology Medical GroupRancho Mirage, California  92270
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Central Coast Medical Oncology CorporationSanta Maria, California  93454
University of Colorado at Denver Health Sciences CenterDenver, Colorado  80045
St. Jude Heritage HealthcareFullerton, California  92835
Sansum ClinicSanta Barbara, California  93105
Santa Barbara Hematology Medical Group, Inc.Santa Barbara, California  93105
Suburban Hematology-Oncology Associates, P.C.Lawrenceville, Georgia  30045
Loyola University ChicagoMaywood, Illinois  60153
Central Hematology Oncology Medical Group, Inc.Terre Haute, Indiana  47802
Hematology & Medical OncologyCleveland, Ohio  44195
Case Western Reserve University/University Hospitals of ClevelandCleveland, Ohio  44106