A Phase I/II Study of Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) (BMS Protocol 180129)
- To determine the Maximum Tolerated Dose (MTD) of Dasatinib in relapsed or refractory
Non-Hodgkin's lymphoma (NHL) patients and to determine the safety of Dasatinib in NHL
- To assess the complete and overall response rates for all Phase I and Phase II patients
and to assay the levels of kinase activity in NHL specimens and correlate this activity
to patient outcomes.
- To determine overall survival and event free survival for all Phase I and Phase II
This study has two phases of treatment, Phase I and Phase II. The Phase I portion of the
trial will consist of a dose escalation plan with 3-6 patients being enrolled into each dose
cohort. The doses of Dasatinib used in Phase I are 100 mg, 150 mg, and 200 mg. The dose
that is found to be tolerated the best and also has the best treatment results will be used
for Phase II. An additional 29 patients will be enrolled into Phase II.
All patients will receive Dasatinib in this study. Dasatinib will be administered orally
(by mouth) once daily for 28 day cycles. A cycle will be considered 28 days. Dosing will
be continuous with no interruptions, unless instructed to interrupt treatment by the
The patient will be restaged after every 2 cycles of therapy, every even cycle. Therapy may
continue as long as there are no clinical signs of NHL progressing and the patient is
tolerating the treatment with no side effects related to the therapy. If the patient is
removed from study for any reason, he/she will be followed for survival until death.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
after 1-28 day cycle of therapy
Julie Vose, M.D.
University of Nebraska
United States: Institutional Review Board
|University of Nebraska Medical Center - Internal Medicine Section of Oncology/Hematology||Omaha, Nebraska 68198-7680|