Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome

NCT ID: NCT01422486

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-02-28

Brief 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).

Detailed 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.

Conditions

Myelodysplastic Syndrome (MDS)

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ezatiostat hydrochloride (Telintra®)

Patients received ezatiostat at a starting dose of 2000 mg total daily dose in divided doses (1000 mg PO b.i.d.) 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.

Group Type: EXPERIMENTAL

ezatiostat hydrochloride (Telintra®)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Telintra; Telinta Tablets; Oral Telintra; ezatiostat; ezatiostat hydrochloride; oral ezatiostat

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Telik

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail L Brown, MD

Role: STUDY_DIRECTOR

Telik

Locations

Loyola University

Maywood, Illinois, United States

SIU School of Medicine, Simmons Cancer Center

Springfield, Illinois, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Columbia University

New York, New York, United States

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

TLK199.2107

Identifier Type: -

Identifier Source: org_study_id