Combination of Nivolumab and DHAP in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP)

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A clinical study of safety and efficacy of treatment with Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
• Treatments: Nivolumab

Criteria

Inclusion Criteria:

• Signed informed consent

• Histologically confirmed Hodgkin's lymphoma

• Measurable disease (at least one lesion that can be accurately measured in at least two dimensions with spiral CT scan, min > 15 mm in the longest diameter or > 10 mm in the short axis)

• World Health Organization (WHO) performance status < 2

• Relapsed or refractory to at least one prior treatment line

• No prior therapy with DHAP or Nivolumab

• No severe concurrent illness

Exclusion Criteria:

• History of HIV

• Active Hepatitis B or Hepatitis C infection

• Uncontrolled infection (requiring intravenous treatment) at the time of enrollment

• Pregnancy or breastfeeding

• Somatic or psychiatric disorder making the patient unable to sign informed consent

• Active or prior documented autoimmune disease requiring systemic treatment

• No receiving a live vaccine within 30 days prior to first dose of nivolumab

• History of non-infectious pneumonitis that required steroids

• Other malignancy