Status:
TERMINATED
Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome
Lead Sponsor:
Telik
Conditions:
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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) transfus...
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) transfus...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01422486
Start Date
October 1 2011
End Date
February 1 2013
Last Update
November 25 2013
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Loyola University
Maywood, Illinois, United States, 60153
2
SIU School of Medicine, Simmons Cancer Center
Springfield, Illinois, United States, 62794-9677
3
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
4
Columbia University
New York, New York, United States, 10032