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Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma

NCT00550615 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-09-26

Study results available
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Summary

Primary Objective:

* 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.

Secondary Objectives:

* 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.

Conditions

  • Non-Hodgkin's Lymphoma

Interventions

DRUG

Dasatinib

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 Dose cohort # 2 will be 150 mg per day Dose cohort # 3 will be 200 mg per day The MTD will be determined in the Phase I portion of this trial.

DRUG

Dasatinib Maximum Tolerated Dose

An additional 29 patients using the Two-Stage Simon design will be enrolled into Phase II using the MTD determined in Phase I.

Sponsors & Collaborators

Principal Investigators

  • Julie Vose, M.D. · University of Nebraska

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-17
Primary Completion
2016-08-01
Completion
2017-12-01

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00550615 on ClinicalTrials.gov