Dose-Ranging Study of Telintra® Tablets + Revlimid® in Patients With Non-Deletion (5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Telik

Status and phase

Completed

Phase 1

Conditions

Myelodysplastic Syndrome

Treatments

Drug: Lenalidomide (Revlimid®)

Drug: Ezatiostat Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01062152

TLK199.1104

Details and patient eligibility

About

This is an open label, multicenter Phase 1 dose escalation study evaluating five doses of ezatiostat in combination with lenalidomide in patients with non-del(5q) low to intermediate 1 risk MDS. The HI-E, HI-N, HI-P rates [by International Working Group (IWG) 2006 criteria] and safety of each treatment group will be evaluated to select the optimal dose of ezatiostat in combination with lenalidomide for future studies.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologic diagnosis of primary or de novo MDS using WHO classification
Non-del(5q) low or Intermediate-1risk MDS
ECOG performance status of 0-1
Documented significant cytopenia for at least 2 months
Must have discontinued growth factors (EPO, G-CSF, GM-CSF) for at least 21 days prior to study entry
All study participants must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist®
Females of childbearing potential should have two negative serum pregnancy tests with a sensitivity of at least 50 mIU/mL. The first test should be performed within 10-14 days, and the second test within 24 hours of prescribing lenalidomide (prescriptions must be filled within seven days)

Exclusion criteria

Known hypersensitivity to Telintra™ (intravenous or oral)
Known prior therapy with or hypersensitivity to thalidomide or lenalidomide
Prior allogenic bone marrow transplant for MDS
History or prior malignancy
- Except for treated carcinoma of uterine cervix, basal cell or squamous cell skin cancer, or other cancers (e.g. breast, prostate) for which patient has been disease-free for at least 3 years.
MDS evolving from:
- A pre-existing myeloproliferative disorder
- An autoimmune disease
- Secondary to prior treatment with radiation or chemotherapy
History of MDS IPSS score>1.0
Pregnant or lactating women
Leptomeningeal or leukemic meningitis
Prior treatment with DNA methyltransferase inhibitors (DMTI) [e.g., azacitadine, decitabine, etc.]