Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00035867

Enrollment

Registered

2002-05-07

Start date

2002-04-30

Completion date

2007-05-31

Last updated

2008-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes

Brief summary

The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).

Interventions

DRUGTLK199 HCl Liposomes for Injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 entry

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026