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Phase 2 Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Lenalidomide (Revlimid®) Refractory or Resistant, Low to Intermediate-1 Risk, Deletion 5q Myelodysplastic Syndrome


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndrome (MDS)

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Trial Information

Phase 2 Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Lenalidomide (Revlimid®) Refractory or Resistant, Low to Intermediate-1 Risk, Deletion 5q Myelodysplastic Syndrome


Inclusion Criteria:



- Primary or de Novo MDS

- Low or Intermediate-1 IPSS risk MDS

- Deletion of the 5q chromosome [del(5q) MDS]

- Refractory or resistant to lenalidomide (Revlimid)

- ECOG performance score of 0 or 1

- Documentation of significant anemia with or without additional cytopenia

- 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

- Known sensitivity to ezatiostat (injection or oral tablets)

- Prior treatment with hypomethylating agent (HMA) (e.g., azacitadine, decitabine)

- History of MDS IPSS risk score of 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 greater than 10 mg per day. Exceptions: those prescribed for other
conditions (such as new adrenal failure, asthma, arthritis) or brief steroid use
(such as tapered dosing for an acute non-MDS condition)

- History of hepatitis B or C, or HIV

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:

Hematologic Improvement-Erythroid (HI-E) rate

Outcome Description:

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

Outcome Time Frame:

At 8 weeks of treatment

Safety Issue:

No

Principal Investigator

Gail L Brown, MD

Investigator Role:

Study Director

Investigator Affiliation:

Telik

Authority:

United States: Food and Drug Administration

Study ID:

TLK199.2107

NCT ID:

NCT01422486

Start Date:

August 2011

Completion Date:

October 2013

Related Keywords:

  • Myelodysplastic Syndrome (MDS)
  • Hematology
  • MDS
  • Myelodysplastic Syndrome
  • Low risk MDS
  • Intermediate-1 risk MDS
  • Int-1 risk MDS
  • Transfusion dependence
  • Lenalidomide refractory
  • Revlimid refractory
  • Lenalidomide resistant
  • Revlimid resistant
  • Telintra
  • ezatiostat
  • ezatiostat hydrochloride
  • TLK199
  • Glutathione
  • Glutathione analog
  • Glutathione Transferase
  • Glutathione Transferase P1-1 inhibitor
  • GST P1-1 inhibitor
  • Apoptosis
  • Differentiation
  • Enzyme inhibitor
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Columbia UniversityNew York, New York  10032-3784
Vanderbilt UniversityNashville, Tennessee  37232-6305
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Loyola UniversityMaywood, Illinois  60153
SIU School of Medicine, Simmons Cancer CenterSpringfield, Illinois  62794-9677