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

Primary Purpose

Classical Hodgkin Lymphoma

Status
Active
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Nivolumab
Adriamycin
Vinblastine
Dacarbazine
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Classical Hodgkin Lymphoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Cologne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm Description

4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)

4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)

Outcomes

Primary Outcome Measures

Complete Remission Rate

Secondary Outcome Measures

Treatment related Morbidity
Progression Free Survival
Overall Survival

Full Information

First Posted
November 7, 2016
Last Updated
September 12, 2023
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT03004833
Brief Title
Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
Acronym
NIVAHL
Official Title
Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Classical Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
Arm Title
Arm B
Arm Type
Experimental
Arm Description
4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Infusion of Nivolumab
Intervention Type
Drug
Intervention Name(s)
Adriamycin
Intervention Description
Infusion of Adriamycin
Intervention Type
Drug
Intervention Name(s)
Vinblastine
Intervention Description
Infusion of Vinblastine
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Intervention Description
Infusion of Dacarbazine
Primary Outcome Measure Information:
Title
Complete Remission Rate
Time Frame
4 to 6 weeks after end of treatment
Secondary Outcome Measure Information:
Title
Treatment related Morbidity
Time Frame
1 year after end of treatment
Title
Progression Free Survival
Time Frame
1 and 3 years after end of treatment
Title
Overall Survival
Time Frame
1 and 3 years after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: large mediastinal mass extranodal lesions elevated ESR ≥ 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Engert, Prof.
Organizational Affiliation
University of Cologne, I. Dept. of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Cologne
City
Cologne
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34520052
Citation
Gerhard-Hartmann E, Goergen H, Brockelmann PJ, Mottok A, Steinmuller T, Grund J, Zamo A, Ben-Neriah S, Sasse S, Borchmann S, Fuchs M, Borchmann P, Reinke S, Engert A, Veldman J, Diepstra A, Klapper W, Rosenwald A. 9p24.1 alterations and programmed cell death 1 ligand 1 expression in early stage unfavourable classical Hodgkin lymphoma: an analysis from the German Hodgkin Study Group NIVAHL trial. Br J Haematol. 2022 Jan;196(1):116-126. doi: 10.1111/bjh.17793. Epub 2021 Sep 14.
Results Reference
derived
PubMed Identifier
32352505
Citation
Brockelmann PJ, Goergen H, Keller U, Meissner J, Ordemann R, Halbsguth TV, Sasse S, Sokler M, Kerkhoff A, Mathas S, Huttmann A, Bormann M, Zimmermann A, Mettler J, Fuchs M, von Tresckow B, Baues C, Rosenwald A, Klapper W, Kobe C, Borchmann P, Engert A. Efficacy of Nivolumab and AVD in Early-Stage Unfavorable Classic Hodgkin Lymphoma: The Randomized Phase 2 German Hodgkin Study Group NIVAHL Trial. JAMA Oncol. 2020 Jun 1;6(6):872-880. doi: 10.1001/jamaoncol.2020.0750.
Results Reference
derived
Links:
URL
http://www.ghsg.org
Description
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Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma

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