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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome

Thank you

Trial Information

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)


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.]

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the maximum tolerated dose (MTD) of ezatiostat in combination with lenalidomide

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Gail Brown, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Telik

Authority:

United States: Food and Drug Administration

Study ID:

TLK199.1104

NCT ID:

NCT01062152

Start Date:

November 2009

Completion Date:

March 2013

Related Keywords:

  • Myelodysplastic Syndrome
  • Hematology
  • MDS
  • Myelodysplastic Syndrome
  • Low risk MDS
  • Patients with non-deletion(5q)
  • Non-deletion 5q
  • Non del(5q)
  • Revlimid
  • lenalidomide
  • 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

University of Rochester Medical CenterRochester, New York  14642
Cleveland ClinicCleveland, Ohio  44195
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Mayo ClinicScottsdale, Arizona  
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Columbia University Medical CenterNew York, New York  10032
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Loyola University Chicago Cardinal Benardin Cancer CenterMaywood, Illinois  60153
MDAndersonHouston, Texas  77030