Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma
- 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 determine overall survival and event free survival for all Phase I and Phase II patients.
- To assay the levels of kinase activity in NHL specimens and correlate this activity to patient outcomes.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) (BMS Protocol 180129)|
- Maximum Tolerated Dose [ Time Frame: after 1-28 day cycle of therapy ] [ Designated as safety issue: Yes ]
- Clinical Response [ Time Frame: after 2-28 day cycles of therapy ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Dose Cohort # 1||
Dasatinib will be orally administered once daily for 28 day cycles.
There will be three dose cohorts for the Dasatinib in the Phase I portion of this trial. A minimum of three patients will be enrolled into each of the following dose cohorts:
Dose cohort # 1 will be 100 mg per day
The MTD will be determined in the Phase I portion of this trial. An additional 29 patients using the Two-Stage Simon design will be enrolled into Phase II using the MTD determined in Phase I.
Other Name: Spryocel
|Active Comparator: Dose Cohort # 2||
Dose cohort # 2 will be 150 mg per day
|Active Comparator: Dose Cohort # 3||
Dose cohort # 3 will be 200 mg per day
- 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 patients.
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 treating physician.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550615
|United States, Nebraska|
|University of Nebraska Medical Center - Internal Medicine Section of Oncology/Hematology|
|Omaha, Nebraska, United States, 68198-7680|
|Principal Investigator:||Julie Vose, M.D.||University of Nebraska|