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Monoclonal Antibodies
Nivolumab + Axatilimab for Hodgkin's Lymphoma (NAHL Trial)
Phase 2
Recruiting
Led By Harsh Shah, MD
Research Sponsored by University of Utah
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 3 years
Awards & highlights
NAHL Trial Summary
This trial will study a combo of drugs to treat relapsed/refractory Hodgkin Lymphoma, to see if it works as expected.
Who is the study for?
Adults with relapsed or refractory Classical Hodgkin Lymphoma who have tried anti-PD-1/anti-PDL-L1 therapy like nivolumab can join. They need measurable disease, good organ function, and no recent transplants or immunosuppressive treatments. Pregnant women can't participate, and effective contraception is required.Check my eligibility
What is being tested?
The trial tests a combination of two drugs: Nivolumab and Axatilimab in patients whose Hodgkin Lymphoma didn't respond to previous treatments. It aims to see if this drug duo works better together for these patients.See study design
What are the potential side effects?
Possible side effects include immune system reactions that could affect organs, infusion-related reactions from the drug entering the body, fatigue, blood disorders, increased risk of infections, and potential muscle issues.
NAHL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) as measured by Best Overall Response Rate (BOR) measured by the proportion of subjects achieving a confirmed PR and CR as defined by Lugano Criteria
Secondary outcome measures
Duration of response (DoR), defined as the interval of time from the date of initial documented response (PR or better per Lugano) to the time of progression from the best response, the start of a new therapy, or death from any cause.
ORR as measured by lymphoma response to immunomodulatory therapy criteria (LYRIC).
Overall survival (OS) as defined as the time from registration until death from any cause.
+3 moreNAHL Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment: All PatientsExperimental Treatment2 Interventions
Nivolumab 480 mg IV Q4 weeks Axatilimab (SNDX 6532) dose (3mg/kg IV) Q4 weeks. If DLT criteria are met, Axatilimab dosing will be reduced to 2mg/kg IV Q4W for the remainder of patients on the study.
The combination will be continued until progression/toxicity up to a maximum of 12 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,680 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,156 Total Patients Enrolled
Harsh Shah, MDPrincipal InvestigatorHuntsman Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had PML, HLH, CNS vasculitis, uncontrolled seizures, or neurodegenerative disease.I have brain metastases or cranial epidural disease.I do not have any severe illnesses that are not under control.I do not have an active infection, including tuberculosis.I haven't had major surgery in the last 4 weeks or I've fully recovered from it.I haven't been diagnosed with another cancer in the last 2 years.I have been treated with drugs targeting CSF-1, CSF-1R, or IL-34.I have recovered from side effects of previous cancer treatments.I can't have a transplant but have been treated with anti-PD(L)1 therapy.I had a stem cell transplant from a donor within the last 3 months or am being treated for graft vs host disease.I have a serious liver condition.I have HIV with a detectable viral load in the last 6 months.I do not have any health issues that would prevent me from joining a study.I have a serious lung condition.I agree to use effective birth control during the study.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.My organs work well without needing transfusions or growth factors in the last week.My blood counts meet the required levels for treatment.I am not pregnant or I am post-menopausal.I have a muscle condition that increases my CK levels.My kidneys work well enough (creatinine clearance ≥ 50 mL/min).I haven't had extensive radiation to my bone marrow or any palliative radiation in the last 2 weeks.My cancer did not worsen after receiving specific immune therapy.My liver function tests are within the required limits.I had a stem cell transplant over 90 days ago and haven't taken immunosuppressants for at least 2 months.I haven't had cancer treatment or experimental therapy in the last 14 days.I haven't taken steroids or immunosuppressants in the last 14 days.I had a severe reaction to previous immunotherapy.My Hodgkin Lymphoma has returned or didn't respond to treatment, and I've had anti-PD-1/PD-L1 therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment: All Patients
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Treatment: All Patients?
"Treatment: All Patients received a score of 2 on our team's safety scale as there is only preliminary evidence indicating its effectiveness, but already established data supporting that it is safe."
Answered by AI
Is enrollment available for this research program?
"Analysis of the clinicaltrials.gov entry for this trial confirms it is not currently searching for participants, as its last update was on February 1st 2023. While no longer recruiting patients, 1685 other trials are presently in need of volunteers."
Answered by AI
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