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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01422486
Other study ID # TLK199.2107
Secondary ID
Status Terminated
Phase Phase 2
First received August 18, 2011
Last updated November 20, 2013
Start date October 2011
Est. completion date February 2013

Study information

Verified date November 2013
Source Telik
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic Syndrome (MDS).


Description:

Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic Syndrome (MDS). Independence from red blood cell transfusions, improvement in the levels of red blood cells, white blood cells, and platelets, and the response of the bone marrow were evaluated. Patients received a starting dose of 2000 mg total daily dose in divided doses (1000 mg orally twice daily for three weeks (21 days) on therapy followed by a one-week (7 days) off therapy rest period in four-week (28 days) treatment cycles. Patients continued treatment until documentation of lack of MDS response, MDS progression, unacceptable toxicity, or patient withdrawal from the study.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Intervention

Drug:
ezatiostat hydrochloride (Telintra®)
Three weeks of treatment with ezatiostat at 2000 mg per day in divided doses followed by a one week rest period in four-week treatment cycles.

Locations

Country Name City State
United States Center for Cancer and Blood Disorders Bethesda Maryland
United States Loyola University Maywood Illinois
United States Vanderbilt University Nashville Tennessee
United States Columbia University New York New York
United States SIU School of Medicine, Simmons Cancer Center Springfield Illinois

Sponsors (1)

Lead Sponsor Collaborator
Telik

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hematologic Improvement-Erythroid (HI-E) rate Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006) At 8, 16, 24, and 32 weeks of treatment No
Secondary RBC Transfusion independence (TI) rate At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment No
Secondary Hematologic Improvement-Neutrophil (HI-N) rate Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006) At 8, 16, 24, & 32 weeks of treatment No
Secondary Hematologic Improvement-Platelet (HI-P) rate Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006) At 8, 16, 24, & 32 weeks of treatment No
Secondary Unilineage, bilineage, trilineage, and overall HI response rate 2 years No
Secondary Cytogenetic response rate 16 weeks, 48 weeks and at the time of first HI response No
Secondary Duration of response 2 years No
Secondary Safety of ezatiostat in this MDS population Recording and grading of AEs using NCI-CTCAE v4.03 At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment No
Secondary Evaluation of the relationship between HI-E response, gene expression profiling and response-related variables 2 years No
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