Clinical trial

Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma

Name

Uni-Koeln-2854

Description

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.

Trial arms

Trial start

2017-02-21

Estimated PCD

2023-12-01

Trial end

2023-12-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Nivolumab

Infusion of Nivolumab

Arms:

Arm A, Arm B

Adriamycin

Infusion of Adriamycin

Arms:

Arm A, Arm B

Vinblastine

Infusion of Vinblastine

Arms:

Arm A, Arm B

Dacarbazine

Infusion of Dacarbazine

Arms:

Arm A, Arm B

Size

110

Primary endpoint

Complete Remission Rate

4 to 6 weeks after end of treatment

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 110, 'type': 'ACTUAL'}}

Updated at

2023-09-13

1 organization

1 product

3 drugs

1 indication

Organization

University of Cologne

Drug

Indication

Drug

Product

Drug