Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma
NCT ID: NCT01535924
Last Updated: 2021-11-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
26 participants
INTERVENTIONAL
2012-02-09
2019-02-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
gemcitabine hydrochloride
Given IV
bendamustine hydrochloride
Given IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
gemcitabine hydrochloride
Given IV
bendamustine hydrochloride
Given IV
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beth Christian
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Beth Christian
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Beth Christian, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emory University
Atlanta, Georgia, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cohen JB, Wei L, Maddocks KJ, Christian B, Heffner LT, Langston AA, Lechowicz MJ, Porcu P, Flowers CR, Devine SM, Blum KA. Gemcitabine and bendamustine is a safe and effective salvage regimen for patients with recurrent/refractory Hodgkin lymphoma: Results of a phase 1/2 study. Cancer. 2020 Mar 15;126(6):1235-1242. doi: 10.1002/cncr.32640. Epub 2019 Dec 10.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Jamesline
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2012-00022
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-11015
Identifier Type: -
Identifier Source: org_study_id