780143
Last Update Posted: 2018-11-09
Recruiting has ended
All Genders accepted | 18 Years + |
3 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Clinical Study of Plitidepsin (Aplidin®) in Combination With Cytarabine in Patients With Relapsed/Refractory Leukemia
This is a Phase I/II study to determine the safety, tolerability and to identify the MTD and DLT of Plitidepsin in combination with a fixed dose of Cytarabine in patients with relapsed/refractory leukemia and to determine the response rate of the combination of Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.
This is a Phase I/II study to determine:
- the safety, tolerability and to identify the MTD and DLT of Plitidepsin in combination with a fixed dose of Cytarabine in patients with relapsed/refractory leukemia and to determine the response rate of the combination of Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.
- the pharmacokinetic parameters of Plitidepsin in combination with Cytarabine.
- whether Plitidepsin in combination with Cytarabine exerts antiangiogenic effects as measured by reduction in microvessel density and VEGFR-1 expression in bone marrow biopsies of patients with relapsed/refractory leukemia.
- whether measurement of free serum VEGF levels, soluble circulating VEGF Receptor and Peripheral Progenitor Endothelial cells provide an early marker of response to Plitidepsin.
- the effects of Plitidepsin and Cytarabine on cytidine deaminase activity and correlate results with Cytarabine drug resistance.
- changes in leukemic gene expression as a result of Plitidepsin and Cytarabine administration.
- tumor response duration.
- progression free survival and overall survival.
Eligibility
Relevant conditions:
Relapsed/Refractory Leukemia
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Contact Information
Overall Contact
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Data sourced from ClinicalTrials.gov