Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma

Classical Hodgkin Lymphoma Clinical Trial

— NIVAHL  

Official title:

Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03004833
• Other study ID #: Uni-Koeln-2854
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

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

External Links

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