Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
1 other identifier
interventional
65
1 country
9
Brief Summary
The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2002
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 6, 2002
CompletedFirst Posted
Study publicly available on registry
May 7, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJune 3, 2008
June 1, 2005
May 6, 2002
May 30, 2008
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of MDS
- Adequate liver and kidney function
- Ineligible for, or refusing, allogeneic bone marrow transplant
- At least 18 years of age
- Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study entry
You may not qualify if:
- Failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry
- Pregnant or lactating women
- History of allergy to eggs
- Other investigational drugs within 14 days of study entry
- Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
- Concomitant steroids or hormones for the treatment of neoplasms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teliklead
Study Sites (9)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
The Angeles Clinic & Research Institute
Los Angeles, California, 90404, United States
University of Chicago
Chicago, Illinois, 60637, United States
Midwest Cancer Research Group
Skokie, Illinois, 60077, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Texas Cancer Associates
Dallas, Texas, 75231, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Related Publications (1)
Raza A, Galili N, Callander N, Ochoa L, Piro L, Emanuel P, Williams S, Burris H 3rd, Faderl S, Estrov Z, Curtin P, Larson RA, Keck JG, Jones M, Meng L, Brown GL. Phase 1-2a multicenter dose-escalation study of ezatiostat hydrochloride liposomes for injection (Telintra, TLK199), a novel glutathione analog prodrug in patients with myelodysplastic syndrome. J Hematol Oncol. 2009 May 13;2:20. doi: 10.1186/1756-8722-2-20.
PMID: 19439093DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 6, 2002
First Posted
May 7, 2002
Study Start
April 1, 2002
Study Completion
May 1, 2007
Last Updated
June 3, 2008
Record last verified: 2005-06