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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from discontinuation of study therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from discontinuation of study therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response (CR) rate (Phase II)
Maximum tolerable dose (Phase I)
Secondary outcome measures
Duration of response (Phase II)
Overall response rate (Phase II)
Overall survival (OS) (Phase II)
+1 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
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%
Cerebral infarction
1%
Ischaemic stroke
1%
Dyspnoea
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)

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
2,696 Previous Clinical Trials
6,952,534 Total Patients Enrolled
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,519 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,460 Total Patients Enrolled

Media Library

Bendamustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03739619 — Phase 1 & 2
Hodgkin's Lymphoma Research Study Groups: Gemcitabine, bendamustine, nivolumab
Hodgkin's Lymphoma Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT03739619 — Phase 1 & 2
Bendamustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03739619 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of medical condition is Gemcitabine most regularly employed to treat?

"Gemcitabine is a go-to medication for treating malignant neoplasms, but has also been found to be beneficial in managing unresectable melanoma, squamous cell carcinoma, and non-small cell lung cancer."

Answered by AI

What is the magnitude of participants involved in this experiment?

"Unfortunately, this clinical trial is not currently enrolling individuals. It was initially posted on November 26th 2018 and recently updated on September 2nd 2022. However, there are 1727 trials for classical Hodgkin's lymphoma that are actively recruiting as well as 1209 studies for Gemcitabine which may be of interest to you."

Answered by AI

What prior studies have utilized Gemcitabine?

"Currently, there are over 1209 clinical assessments of Gemcitabine in progress with 229 studies actively undertaking Phase 3. While Woolloongabba, Queensland hosts a number of such trials, it is only one amongst the 65002 sites conducting investigations into this medication."

Answered by AI

What are the primary goals of this experimentation?

"The primary purpose of this trial, evaluated over the span of two years since participants stopped taking their medication, is to determine the highest tolerable dose (Phase I). Secondary objectives focus on gauging duration of response using Lugano Criteria (Phase II), overall survival based off Lugano criteria from first day dosing until death due to any cause (Phase II), and progression-free survival measured by Lugano criteria starting at initial drug administration till progression or mortality (Phase II)."

Answered by AI

Is recruitment still underway for this experiment?

"Unfortunately, this research endeavour is no longer seeking potential candidates. Initially posted on November 26th 2018, the trial was last edited on September 2nd 2022. If you are interested in similar studies, there are 1727 trials for classical Hodgkin's lymphoma and 1209 trials involving Gemcitabine that are currently recruiting participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Jonathon Cohen 2018. "Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03739619.
~6 spots leftby Dec 2024
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