Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study Evaluating the Efficacy and Safety of the Farnesyl-transferase Inhibitor ZARNESTRA® in Patients With Relapsed, Refractory or Progressive Mantle Cell Lymphoma Not Appropriate for Autologous Bone Marrow Transplantation
To determine the EFFICACY and the SAFETY PROFILE and TOXICITY of Zarnestra® in the treatment
of patients with previously treated mantle cell lymphoma not appropriate for autologous bone
marrow transplantation. 27 evaluable subjects will be enrolled for an analysis in 2 stages
(11 for the first stage, 16 for the second).
Patients who receive at least one dose of Zarnestra® and have at least one post-baseline
response assessment of discontinued study frug for early progression are evaluable. Subjects
not evaluable for response will be replaced, up to 35 patients.
Zarnestra® will be administered at 300 mg administered orally twice daily for the first 21
days of each 28-days cycle. Tipifarnib treatment stops no later than day 21 of each cycle.
Subjects will receive a total of 4 cycles of treatment. Two additional cycles might be
administered for patients showing improvement to PR after 4 cycles.
After testing the drug on 11 patients in the first stage, the trial will be terminated if 1
or fewer respond and the drug will not be considered as effective.
If two or more patients respond in the first stage, the trial goes on to the second stage to
include a total of 27 patients.
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