A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies
OBJECTIVES:
I. To determine the feasibility and safety of Gemcitabine/Carboplatin/Dexamethasone with or
without Rituximab in previously treated lymphoid malignancies (rituximab will only be
evaluated in CD20 positive malignancies).
II. To determine the efficacy of the above regimen. III. To determine the ability to proceed
to blood stem peripheral blood collection following the above regimens (the impact of above
regimen on stem cell reserve).
IV. To determine remission duration.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
GROUP I: CD20-NEGATIVE LYMPHOMAS
GROUP II: CD20-POSITIVE LYMPHOMAS
After completion of study treatment, patients are followed up at 3-4 weeks and then every 6
months for 5 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Ability to successfully deliver the investigational therapy without incurring the protocol suspension rules
At 3-4 weeks after completion of study treatment
No
Ajay Gopal
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
PSOC 2003
NCT00072514
August 2003
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |