A Phase I/II Study Of Gemcitabine And Bendamustine In Patients With Relapsed Or Refractory Hodgkin's Lymphoma
I. To evaluate the toxicity and determine the maximum tolerated dose (MTD) of combined
bendamustine (bendamustine hydrochloride) and gemcitabine (gemcitabine hydrochloride) in
patients with relapsed or refractory Hodgkin's lymphoma.
II. To determine the overall response rate of bendamustine and gemcitabine in patients with
relapsed and refractory Hodgkin's lymphoma.
I. To determine whether therapy with bendamustine in the setting of relapsed or refractory
Hodgkin's lymphoma will impact future stem cell collection.
OUTLINE: This is a phase I, dose-escalation study of bendamustine hydrochloride followed by
a phase II study.
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1 and
bendamustine hydrochloride IV over 30 minutes on days 1 and 2. Treatment repeats every 21-28
days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 2 years,
then every 6 months for up to 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse events in terms of dose-limiting toxicity (DLT) and MTD of bendamustine hydrochloride (Phase I)
Determined using Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria. Descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data) and graphical analyses will be used for all correlative laboratory parameters. The associations between correlative laboratory parameters and clinical response will be evaluated using two sample t test or Fisher's exact test, whichever is appropriate.
up to 5 years
Kristie Blum, MD
Ohio State University
United States: Food and Drug Administration
|Ohio State University Medical Center||Columbus, Ohio 43210|