Relapsed/Refractory Leukemia Clinical Trial
Official title:
Phase I/II 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00724360 -
Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)
|
Phase 2 |