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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | 4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy) |
|
| Arm B | Experimental | 4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Infusion of Nivolumab |
| |
| Adriamycin |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission Rate | 4 to 6 weeks after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related Morbidity | 1 year after end of treatment | |
| Progression Free Survival | 1 and 3 years after end of treatment | |
| Overall Survival |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Engert, Prof. | University of Cologne, I. Dept. of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Cologne | Cologne | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41926569 | Derived | Robertz AS, Buhnen I, Meissner J, Trautmann-Grill K, Herhaus P, Halbsguth TV, Schaub V, Kerkhoff A, Mathas S, Bormann M, Dickhut A, Jaworek CP, Fuchs M, Kobe C, Baues C, Borchmann P, von Tresckow B, Behringer K, Brockelmann PJ. Gonadal function and fertility after Hodgkin lymphoma treatment with nivolumab-AVD in the phase 2 GHSG NIVAHL trial. Blood. 2026 Jun 18;147(25):3118-3121. doi: 10.1182/blood.2025031809. | |
| 36508302 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D004317 | Doxorubicin |
| D014747 | Vinblastine |
| D003606 | Dacarbazine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
Infusion of Adriamycin |
|
| Vinblastine | Drug | Infusion of Vinblastine |
|
| Dacarbazine | Drug | Infusion of Dacarbazine |
|
| 1 and 3 years after end of treatment |
| Derived |
| 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. |
| 34520052 | Derived | 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. |
| 32352505 | Derived | 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. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |