Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome
Myelodysplastic Syndrome (MDS)
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome (MDS) focused on measuring 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
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
Sites / Locations
- Loyola University
- SIU School of Medicine, Simmons Cancer Center
- Center for Cancer and Blood Disorders
- Columbia University
- Vanderbilt University
Arms of the Study
Arm 1
Experimental
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.