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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03004833
Other study ID # Uni-Koeln-2854
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date February 21, 2017
Est. completion date December 2023

Study information

Verified date September 2023
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 110
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nivolumab
Infusion of Nivolumab
Adriamycin
Infusion of Adriamycin
Vinblastine
Infusion of Vinblastine
Dacarbazine
Infusion of Dacarbazine

Locations

Country Name City State
Germany University Hospital of Cologne Cologne

Sponsors (1)

Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete Remission Rate 4 to 6 weeks after end of treatment
Secondary Treatment related Morbidity 1 year after end of treatment
Secondary Progression Free Survival 1 and 3 years after end of treatment
Secondary Overall Survival 1 and 3 years after end of treatment
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