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Nivolumab Maintenance Therapy After Autologous Stem Cell Transplant in Hodgkin Lymphoma Pts at Relapse/Progression Risk | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Nivolumab Maintenance Therapy After Autologous Stem Cell Transplant in Hodgkin Lymphoma Pts at Relapse/Progression Risk

A Phase II Single Arm Study of Nivolumab as Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Hodgkin Lymphoma at Risk of Relapse or Progression

NCT03436862•SCRI Development Innovations, LLC

View on ClinicalTrials.gov

Summary

This is a Phase II single-arm open-label study of nivolumab as maintenance therapy after autologous stem cell transplantation in patients with Hodgkin lymphoma at risk of relapse or progression.

Detailed Description

The primary objective of this study is to evaluate safety and tolerability of nivolumab as maintenance therapy early after autologous stem cell transplant in patients with Hodgkin's Lymphoma (HL). Eligible patients will receive nivolumab (240 mg IV) every 2 weeks (± 2 days as long as interval between doses is 12-16 days) starting 45-120 post-transplant for up to a maximum of 6 months of treatment. Response to treatment will be assessed 6 months and 1 year post-transplant using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients 18 years of age and older with Hodgkin Lymphoma who have received auto-HSCT in the previous 45-120 days.
•Complete response (CR), partial response (PR) or stable disease (SD) to salvage therapy prior to ASCT.
•High risk of residual HL post-ASCT, as determined by 1 of the following:
•* Positive positron emission tomography (PET) scan defined by the Deauville scale 3-4 and within 2 months of start of high dose chemotherapy prior to ASCT
•* Refractory to frontline therapy
•* Relapse \<12 months after frontline therapy
•* Relapse ≥12 months after frontline therapy with extra-nodal disease
•Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 - 1.
•Adequate hematologic function defined as all of the following:
•* Absolute neutrophil count (ANC) ≥1000/μL
+24 more criteria

Exclusion Criteria

•Patients that have received an allogenic transplant.
•Post-ASCT or current therapy with other anti-neoplastic or investigational agents.
•Best clinical response of progressive disease prior to ASCT.
•Patients with any autoimmune disease or a history of autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
•Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
•Use of a study drug ≤ 21 days or 5 half-lives (whichever is shorter) prior to the first dose of nivolumab. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of nivolumab is required.
•Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy.
•Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.

Locations (6)

Colorado Blood Cancer Institute

Denver, Colorado, United States

HCA Midwest

Kansas City, Missouri, United States

Tennessee Oncology

Nashville, Tennessee, United States

St. David's South Austin Medical Center

Austin, Texas, United States

Texas Transplant Institute

San Antonio, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

May 23, 2018

Primary Completion Date

May 5, 2022

Completion Date

April 4, 2023

Last Updated

December 5, 2023

Enrollment

ACTUAL participants

Conditions

Hodgkin Lymphoma

Interventions

Nivolumab

DRUG

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

NCT05529069

Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

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RECRUITINGPHASE1

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

NCT06189391

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Nivolumab Maintenance Therapy After Autologous Stem Cell Transplant in Hodgkin Lymphoma Pts at Relapse/Progression Risk

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

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