Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma

NCT05660993 | Unknown Phase 2

• 1 other identifier: r/r cHL-2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of nivolumab combined with salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the 3 mg/kg in combination with Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in patients with relapsed/refractory Hodgkin Lymphoma.

Conditions

Hodgkin Lymphoma

Keywords

PET-adapted Treatment; Relapsed/Refractory Hodgkin Lymphoma; Nivolumab; BeGEV

Outcome Measures

Primary Outcomes (2)

• 1. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 Toxicity parameters based on NCI CTCAE 4.03 grades

  12 months

• 2. Overall Response Rate (ORR) Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC and Lugano 2014 criteria

  12 months

Secondary Outcomes (3)

• 1. Duration of Response (DOR)

  24 months

• Overall Survival (OS)

  24 months

• Progression-Free Survival (PFS)

  24 months

Study Arms (1)

Main arm

EXPERIMENTAL

Patients will receive for a maximum of 4 cycles of nivolumab 3 mg/kg on day 0 BeGEV , with subsequent assessment of response by PET-CT. Patients with CR after 2 cycles Nivo-BeGEV will proceed to ASCT. Patients with \<CR after 2 cycles of a combination Nivo-BeGEV, with subsequent PET-CT assessment, will receive an additional 2 cycles Nivo-BeGEV. Patients with CR after 4 cycles Nivo-BeGEV will proceed to ASCT.

Drug: Nivolumab

Interventions

Nivolumab DRUG

Drug: Nivolumab Schedule: Nivolumab 3 mg/kg on day 0 of the Nivo-BeGEV or a maximum of 4 cycles Drug: Bendamustine Schedule: Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles Other Name: Ribomustin Drug: Gemcitabine Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles Other Name: Gemzar Drug: Vinorelbine Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles Other Name: Navelbine

Main arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis: Histologically confirmed Hodgkins lymphoma
• Relapsed or refractory disease after the first line of treatment
• Age 18-70 years old
• Ejection fraction greater than 50%
• ECOG 0-2 status
• Signed informed consent
• No severe concurrent illness

You may not qualify if:

• Uncontrolled bacterial or fungal infection at the time of enrollment
• Requirement for vasopressor support at the time of enrollment
• Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
• Karnofsky index \<30%
• Pregnancy
• Somatic or psychiatric disorder making the patient unable to sign an informed consent
• Active or prior documented autoimmune disease requiring systemic treatment.

Sponsors & Collaborators

• National Research Center for Hematology, Russia: lead

Study Sites (1)

National Research Center for Hematology

Moscow, 125167, Russia

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Elena Parovichnikova,, MD,PhD

  Nathional Medical Research Center for Hematology Moscow Russia 125167

  STUDY DIRECTOR

Central Study Contacts

Yana Mangasarova, MD

CONTACT

+74956122361; v.k.jana@mail.ru

Eugene Zvonkov, MD,PhD

CONTACT

+7 (495) 612-13-31; dr.zvonkov@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-director Nathional Medical Research Center for Hematology Moscow Russia

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: August 19, 2019
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

RU (1)