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Alkylating agents
GBN for Classical Hodgkin Lymphoma
Phase 1 & 2
Waitlist Available
Led By Jonathon Cohen, MD, MS
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from discontinuation of study therapy
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Summary
This trial is studying gemcitabine, bendamustine, and nivolumab to treat patients with classic Hodgkin lymphoma that has come back or does not respond to treatment.
Who is the study for?
This trial is for adults with classic Hodgkin lymphoma that has returned or didn't respond to treatment. They must have a certain level of physical fitness, no severe lung issues, controlled hypothyroidism or diabetes if present, and adequate organ function. Pregnant or nursing individuals can't join, nor those with central nervous system involvement by lymphoma, autoimmune diseases requiring immunosuppression, or a history of severe drug toxicity.
What is being tested?
The study tests the combination of chemotherapy drugs gemcitabine and bendamustine with the immunotherapy drug nivolumab in patients whose Hodgkin lymphoma has relapsed or is refractory. It aims to find the best dose and assess how well these drugs work together against this type of cancer.
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the medication entering the body, fatigue from treatment-induced exhaustion, digestive problems like nausea or diarrhea, blood disorders affecting cell counts and infection risk due to weakened immunity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from discontinuation of study therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from discontinuation of study therapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete response (CR) rate (Phase II)
Maximum tolerable dose (Phase I)
Secondary study objectives
Duration of response (Phase II)
Overall response rate (Phase II)
Overall survival (OS) (Phase II)
+1 moreSide effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Dyspnoea
1%
Cerebral infarction
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Gemcitabine, bendamustine, nivolumabExperimental Treatment3 Interventions
Patients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bendamustine
FDA approved
Gemcitabine
FDA approved
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,814 Previous Clinical Trials
8,161,557 Total Patients Enrolled
Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,764 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,493 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition relapsed or didn't respond after a stem cell transplant.I have taken gemcitabine, bendamustine, or nivolumab without stopping due to side effects.I am on strong medication for an autoimmune disease.My condition worsened after my first treatment.My lungs work well enough for treatment.My lymphoma has affected or previously affected my brain or spinal cord.My cancer can be measured and is at least 1cm by 1cm on scans.My hypothyroidism or type 1 diabetes is well-controlled with medication.I have had hepatitis C but meet certain health criteria.I am able to get out of my bed or chair and move around.My Hodgkin lymphoma has come back or didn't respond to standard chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Gemcitabine, bendamustine, nivolumab
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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