Status:
COMPLETED
Combination of Nivolumab and DHAP in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP)
Lead Sponsor:
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A clinical study of safety and efficacy of treatment with Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma
Detailed 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04091490
Start Date
February 19 2020
End Date
December 31 2022
Last Update
September 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
Moscow, Russia, 105203