NCT01062152

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

Official Title:

Phase 1 Dose-Ranging Study of Ezatiostat Hydrochloride (Telintra®, TLK199 Tablets)in Combination With Lenalidomide (Revlimid®)in Patients With Non-Deletion(5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Summary

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.

Eligibility

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) \[e.g., azacitadine, decitabine, etc.\]

Disease(s) and\or Condition(s)

Myelodysplastic Syndrome

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: Ezatiostat Hydrochloride
    • Description: Starting dose 2000 mg orally in divided doses twice daily (1000 mg in AM \& 1000 mg in PM) x 21 days with one week off therapy in a 4-week cycle.
    • Arm Group Labels: Revlimid® in Combination with Telintra ®
    • Type: DRUG
    • Name: Lenalidomide (Revlimid®)
    • Description: 10 mg orally per day in one AM dose x 21 days with one week off therapy in a 4-week cycle.
    • Arm Group Labels: Revlimid® in Combination with Telintra ®
Sponsor
  • Telik