Acute Myeloid Leukemia Clinical Trial
Official title:
Phase II, Open-Label, Multi-centre, 2-part Study to Assess the Safety, Tolerability, and Efficacy of Tipifarnib Plus Bortezomib in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) Unfit for Conventional Chemotherapy ( >18 Years) or in Patients With Acute Myeloid Leukemia in First Relapse ( >60 Years)
This is one of the first studies of combination of Zarnestra plus Velcade in man. A primary
objective of the study is therefore to assess the safety and tolerability of multiple doses
of Zarnestra plus Velcade in patients with AML.
New treatments for patients that are untreatable with intensive chemotherapy aged de novo
AML patients or post-relapse AML are urgently required since, at present, many of the drugs
used for second line therapy are the same as those used for first induction and response
rates are much lower.
- The following evidence suggests that Velcade plus Zarnestra can be an attractive
therapeutic combination for: AML patients.
- Affymetrix gene profiling data showed expression of NFkB1 in all of 5 myeloid cell
lines cell lines tested and 35% of over 250 patient samples ( data generated in
collaboration with Sergio Ferrari and Pier Paolo Piccaluga unpublished results, our
Institute and University of Modena,Italy)
- Preclinical evidence showed that AML cells in suspension culture were prevented to
develop de novo drug resistance and mediated drug resistance.
In Part B additional patients with AML will be treated to further characterize the
tolerability,biological effects, and clinical efficacy of the combination Velcade plus
Zarnestra. Patients on treatment for AML will undergo regular bone marrow aspirates and
biopsies to assess responses to treatment. This will facilitate frequent assessment of
biological endpoints (reduction in expression and phosphorylation of IKKb kinase, and
downstream markers of signalling along with apoptosis, survival, proliferation and cellular
size and ploidy) will be made in an attempt to confirm that the desired biological activity
has been achieved at the maximum tolerated dose.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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