Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
NCT ID: NCT03004833
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2017-02-21
2022-08-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
Nivolumab
Infusion of Nivolumab
Adriamycin
Infusion of Adriamycin
Vinblastine
Infusion of Vinblastine
Dacarbazine
Infusion of Dacarbazine
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)
Nivolumab
Infusion of Nivolumab
Adriamycin
Infusion of Adriamycin
Vinblastine
Infusion of Vinblastine
Dacarbazine
Infusion of Dacarbazine
Interventions
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Nivolumab
Infusion of Nivolumab
Adriamycin
Infusion of Adriamycin
Vinblastine
Infusion of Vinblastine
Dacarbazine
Infusion of Dacarbazine
Eligibility Criteria
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Inclusion Criteria
* 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
* History of other malignancy ≤ 5 years
* Prior chemotherapy or radiation therapy
* Concurrent disease precluding protocol treatment
* Pregnancy, lactation
* Non-compliance
18 Years
60 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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Dr. Paul Broeckelmann
Dr.
Principal Investigators
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Andreas Engert, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Cologne, I. Dept. of Medicine
Locations
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University Hospital of Cologne
Cologne, , Germany
Countries
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References
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Brockelmann PJ, Buhnen I, Meissner J, Trautmann-Grill K, Herhaus P, Halbsguth TV, Schaub V, Kerkhoff A, Mathas S, Bormann M, Dickhut A, Kaul H, Fuchs M, Kobe C, Baues C, Borchmann P, Engert A, von Tresckow B. Nivolumab and Doxorubicin, Vinblastine, and Dacarbazine in Early-Stage Unfavorable Hodgkin Lymphoma: Final Analysis of the Randomized German Hodgkin Study Group Phase II NIVAHL Trial. J Clin Oncol. 2023 Feb 20;41(6):1193-1199. doi: 10.1200/JCO.22.02355. Epub 2022 Dec 12.
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.
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.
Related Links
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Related Info
Other Identifiers
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Uni-Koeln-2854
Identifier Type: -
Identifier Source: org_study_id
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