Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma (NIVAHL)

September 12, 2023 updated by: Prof. Dr. Andreas Engert, University of Cologne

The aim of the trial is to improve first-line treatment for early unfavorable cHL by introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy (AVD).

The primary objective is to show efficacy of the two experimental treatment strategies. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany
        • University Hospital of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically proven classical HL
  • First diagnosis, no previous treatment
  • Age: 18-60 years

  • Stage I, IIA with risk factors a-d, IIB with RF c-d:

    1. large mediastinal mass
    2. extranodal lesions
    3. elevated ESR
    4. ≥ 3 nodal areas confirmed by central review.

Exclusion Criteria:

  • Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
  • History of other malignancy ≤ 5 years
  • Prior chemotherapy or radiation therapy
  • Concurrent disease precluding protocol treatment
  • Pregnancy, lactation
  • Non-compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
Drug: Nivolumab
Infusion of Nivolumab
Drug: Adriamycin
Infusion of Adriamycin
Drug: Vinblastine
Infusion of Vinblastine
Drug: Dacarbazine
Infusion of Dacarbazine
Experimental: Arm B
4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)
Drug: Nivolumab
Infusion of Nivolumab
Drug: Adriamycin
Infusion of Adriamycin
Drug: Vinblastine
Infusion of Vinblastine
Drug: Dacarbazine
Infusion of Dacarbazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete Remission Rate
Time Frame: 4 to 6 weeks after end of treatment
4 to 6 weeks after end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment related Morbidity
Time Frame: 1 year after end of treatment
1 year after end of treatment
Progression Free Survival
Time Frame: 1 and 3 years after end of treatment
1 and 3 years after end of treatment
Overall Survival
Time Frame: 1 and 3 years after end of treatment
1 and 3 years after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Andreas Engert, Prof., University of Cologne, I. Dept. of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2017

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (Estimated)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Koeln-2854

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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