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OpenTrials
Completed

NCT Number: NCT03004833

Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma

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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Key information

Conditions

Classical Hodgkin Lymphoma

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Cologne

Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

Infusion of Nivolumab

Adriamycin

Drug

Infusion of Adriamycin

Vinblastine

Drug

Infusion of Vinblastine

Dacarbazine

Drug

Infusion of Dacarbazine

Primary outcomes

  1. Complete Remission Rate

    Time frame: 4 to 6 weeks after end of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Acronym: NIVAHL

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2016
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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