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Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Phase 1/Phase 2
18 Years
Not Enrolling
Myelodysplastic Syndromes

Thank you

Trial Information

Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

April 2002

Completion Date:

May 2007

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Preleukemia



University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Oregon Health & Science University Portland, Oregon  97201
M.D. Anderson Cancer Center Houston, Texas  77030
The Angeles Clinic & Research Institute Los Angeles, California  90404
University of Chicago Chicago, Illinois  60637
Midwest Cancer Research Group Skokie, Illinois  60077
The Sarah Cannon Cancer Center Nashville, Tennessee  37203
Texas Cancer Associates Dallas, Texas  75231