Study on Using A(B)VD Followed by Nivolumab for Initial Treatment in Higher Risk Hodgkin Lymphoma Patients

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT03033914

This clinical trial is exploring whether adding the drug Nivolumab to the standard A(B)VD chemotherapy can improve treatment outcomes for patients with higher risk Hodgkin Lymphoma, especially those with abnormal PET scans after initial treatment cycles.

Patient Parameters

Parameter	Options

Program Overview

The study aims to find out if combining Nivolumab with the standard chemotherapy regimen A(B)VD can increase the chances of curing Hodgkin Lymphoma in patients who are at higher risk. In Phase I, the focus is on understanding the effects of Nivolumab when used with A(B)VD. Phase II will test if adding Nivolumab helps patients with untreated Hodgkin Lymphoma who show abnormal PET scans after two cycles of A(B)VD.

Description

In this study, patients with untreated stage III or IV Hodgkin Lymphoma will start with two cycles of the standard chemotherapy treatment A(B)VD. After these cycles, a PET scan will be done to check the cancer's response. Patients treated at MSK with a negative PET scan result will continue with four more cycles of A(B)VD or AVD, depending on their doctor's decision. Patients with a positive PET scan result will receive four cycles of AVD plus Nivolumab. Non-MSK patients can only join the study if they have a positive PET scan result after the initial treatment.

Eligibility Criteria

Inclusion Criteria

Patients under 60 with untreated stage III or IV classical Hodgkin Lymphoma can join Cohort A.
In Phase I, patients could join if they had a high-risk score or a positive PET scan after two cycles of A(B)VD. Phase I enrollment is now closed, and Phase II is open.
In Phase II, patients under 60 with stage III or IV Hodgkin Lymphoma are eligible. MSK patients can join anytime during the first two cycles of A(B)VD, while non-MSK patients must join after a positive PET scan.
Patients 60 or older with untreated classical Hodgkin Lymphoma can join Cohort B.
Must have a confirmed diagnosis of classical Hodgkin Lymphoma.
Disease must be detectable by FDG-PET/CT scan.
Women of childbearing potential must have a negative pregnancy test before starting the study drug and use reliable birth control methods during the study.
Men must agree to use contraception during the study and for a specified period after treatment.
Must be 18 years or older.
Must have adequate kidney and liver function as indicated by specific blood tests.

Exclusion Criteria

Patients with active brain or leptomeningeal metastases.
Patients with nodular lymphocyte-predominant Hodgkin Lymphoma.
Any serious or uncontrolled medical condition that could increase risks or interfere with the study.
Active cancer within the last three years, except for certain curable cancers.
Active autoimmune diseases, except for specific conditions like vitiligo or type I diabetes.
Need for systemic corticosteroids above a certain dose.
Recent severe heart conditions or low heart function.
Uncontrolled cardiovascular conditions.
Positive tests for hepatitis B or C indicating acute infection.
Known HIV or AIDS.
Severe allergic reactions to monoclonal antibodies.
Certain lung function test results below specified levels.

Locations

FACILITY	ZIP	CITY	STATE
Karmanos Cancer Institute	48201	Detroit	Michigan
Memorial Sloan Kettering Basking Ridge	07920	Basking Ridge	New Jersey
Hackensack Meridian Health	07601	Hackensack	New Jersey
Memorial Sloan Kettering Monmouth	07748	Middletown	New Jersey
Memorial Sloan Kettering Bergen	07645	Montvale	New Jersey
Memorial Sloan Kettering Commack	11725	Commack	New York
Memorial Sloan Kettering Westchester	10604	Harrison	New York
Memorial Sloan Kettering Cancer Center	10065	New York	New York
Memorial Sloan Kettering Nassau	11553	Uniondale	New York

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