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

Phase 2

Completed

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: Nivolumab

• Registration Number: NCT04091490
• Lead Sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

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

Study Timeline

• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-16
• Study Start: 2020-02-19
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR) of Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma	up to 6 months	Overall response rate (ORR), defined as proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano classification and duration of response

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival	up to 12 months
Overall Survival	up to 12 months
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03	up to 6 months	Toxicity parameters based on NCI CTCAE 4.03 grades

Trial Locations

Locations (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, Russian Federation