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

State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Status and phase

Completed

Phase 2

Conditions

Hodgkin Lymphoma

Treatments

Drug: Nivolumab

Study type

Interventional

Funder types

Other

Identifiers

NCT04091490

Nivo-DHAP-cHL-1

Details and patient eligibility

About

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

Full description

A Clinical Study of Safety and Efficacy of Treatment With Nivolumab and Dexamethasone, Cytarabine and Cisplatin (DHAP) in Patients With Relapsed/Refractory Hodgkin's Lymphoma

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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