Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 59 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Given IV
Other Names:
Drug: bendamustine hydrochloride
Given IV
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically documented Classical Hodgkin's lymphoma that is recurrent or refractory after standard chemotherapy; core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as the sole means of diagnosis are not acceptable
Patients with Hodgkin's lymphoma may have one of the following World Health Organization subtypes:
- Nodular sclerosis Hodgkin's lymphoma
- Lymphocyte-rich Hodgkin's lymphoma
- Mixed cellularity Hodgkin's lymphoma
- Lymphocyte depletion Hodgkin's lymphoma
- Nodular lymphocyte predominant Hodgkin's lymphoma
- Patients must have relapsed or progressed after at least one prior therapy
- Patients with relapsed or refractory disease following stem cell transplantation are permitted
- No prior treatment with bendamustine; prior therapy with gemcitabine is permitted
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable
- Measurable disease: lesions that can be accurately measured in at least two dimensions as >= 1.0 x 1.0 cm by computerized tomography (CT), PET/CT (positron emission tomography/CT), or magnetic resonance imaging (MRI)
Non-measurable disease: all other lesions, including small lesions (less than 1.0 x 1.0 cm) and truly non-measurable lesions; lesions that are considered non-measurable include the following:
- Bone lesions (lesions if present should be noted)
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Bone marrow (involvement by Hodgkin's lymphoma should be noted)
- Non-pregnant and non-nursing; due to the teratogenic potential of these agents, pregnant or nursing patients may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control
Patients with human immunodeficiency virus (HIV) infection are eligible; patients with HIV infection must meet the following: No evidence of co-infection with hepatitis B or C; cluster of differentiation (CD)4+ count >= 400/mm; no evidence of resistant strains of HIV; on anti-HIV therapy with an HIV viral load < 50 copies HIV ribonucleic acid (RNA)/mL; no history of acquired immune deficiency syndrome (AIDS) defining conditions
- Granulocytes >= 1000/μl
- Platelet count >= 75,000/μl
- Creatinine =< 20 mg/dL
- Bilirubin =< 2.0 mg/dL
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.0 x upper limits of normal
Contacts and Locations| 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, Ohio | |
| Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Kristie A. Blum, MD 614-293-8858 kristie.blum@osumc.edu | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kristie Blum, Principal Investigator, Ohio State University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01535924 History of Changes |
| Other Study ID Numbers: | OSU-11015, NCI-2012-00022 |
| Study First Received: | February 6, 2012 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ohio State University Comprehensive Cancer Center:
|
Hodgkin's Lymphoma relapsed refractory |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Sclerosis Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Pathologic Processes Gemcitabine Bendamustine Nitrogen Mustard Compounds Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Antineoplastic Agents, Alkylating Alkylating Agents |
ClinicalTrials.gov processed this record on May 19, 2013