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

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ClinicalTrials.gov Identifier: NCT03004833
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne

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.


Condition or disease Intervention/treatment Phase
Classical Hodgkin Lymphoma Drug: Nivolumab Drug: Adriamycin Drug: Vinblastine Drug: Dacarbazine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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




Primary Outcome Measures :
  1. Complete Remission Rate [ Time Frame: 4 to 6 weeks after end of treatment ]

Secondary Outcome Measures :
  1. Treatment related Morbidity [ Time Frame: 1 year after end of treatment ]
  2. Progression Free Survival [ Time Frame: 1 and 3 years after end of treatment ]
  3. Overall Survival [ Time Frame: 1 and 3 years after end of treatment ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004833


Contacts
Contact: Michael Fuchs +49-221-480-88200 ghsg@uk-koeln.de

Locations
Germany
University Hospital of Cologne Recruiting
Cologne, Germany
Contact: Andreas Engert, Prof.         
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Andreas Engert, Prof. University of Cologne, I. Dept. of Medicine

Additional Information:
Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT03004833     History of Changes
Other Study ID Numbers: Uni-Koeln-2854
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nivolumab
Liposomal doxorubicin
Doxorubicin
Vinblastine
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators