Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma
This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride when given together with gemcitabine hydrochloride and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells.
Adult Lymphocyte Depletion Hodgkin Lymphoma
Adult Lymphocyte Predominant Hodgkin Lymphoma
Adult Mixed Cellularity Hodgkin Lymphoma
Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma
Adult Nodular Sclerosis Hodgkin Lymphoma
Recurrent Adult Hodgkin Lymphoma
Drug: gemcitabine hydrochloride
Drug: bendamustine hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study Of Gemcitabine And Bendamustine In Patients With Relapsed Or Refractory Hodgkin's Lymphoma|
- Adverse events in terms of dose-limiting toxicity (DLT) and MTD of bendamustine hydrochloride (Phase I) [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]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.
- Overall response rate of bendamustine hydrochloride and gemcitabine hydrochloride in patients with relapsed or refractory Hodgkin lymphoma (Phase II) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]Tested using Simon's two-stage Minimax design. 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.
|Study Start Date:||February 2012|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (combination chemotherapy)
Patients receive gemcitabine hydrochloride 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.
Drug: gemcitabine hydrochloride
Other Names:Drug: bendamustine hydrochloride
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535924
|Contact: Ohio State University Comprehensive Cancer Center||1-800-293-5066||Jamesline@osumc.edu|
|Contact: Kristie Blum, MD||614-293-4590||Kristie.Blum@osumc.edu|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Jonathon B. Cohen, MD, MS 404-778-2214|
|United States, Ohio|
|Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Kristie A. Blum, MD 614-293-8858 email@example.com|
|Principal Investigator: Kristie A. Blum, MD|
|Sub-Investigator: Leslie Andritsos, MD|
|Sub-Investigator: Robert Baiocchi, MD|
|Sub-Investigator: Don Benson, MD|
|Sub-Investigator: John Byrd, MD|
|Sub-Investigator: Beth Christian, MD|
|Sub-Investigator: Johnathan Cohen, MD|
|Sub-Investigator: Steven Devine, MD|
|Sub-Investigator: Joseph Flynn, DO|
|Sub-Investigator: Jeffrey Jones, MD|
|Sub-Investigator: Sam Penza, MD|
|Sub-Investigator: Pierluigi Porcu, MD|
|Principal Investigator:||Kristie Blum, MD||Ohio State University|