Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Main arm 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
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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 1. Duration of Response (DOR) [24 months]
- Overall Survival (OS) [24 months]
- Progression-Free Survival (PFS) [24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis: Histologically confirmed Hodgkins lymphoma
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Relapsed or refractory disease after the first line of treatment
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Age 18-70 years old
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Ejection fraction greater than 50%
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ECOG 0-2 status
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Signed informed consent
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No severe concurrent illness
Exclusion Criteria:
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Uncontrolled bacterial or fungal infection at the time of enrollment
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Requirement for vasopressor support at the time of enrollment
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Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
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Karnofsky index <30%
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Pregnancy
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Somatic or psychiatric disorder making the patient unable to sign an informed consent
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Active or prior documented autoimmune disease requiring systemic treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Research Center for Hematology | Moscow | Russian Federation | 125167 |
Sponsors and Collaborators
- National Research Center for Hematology, Russia
Investigators
- Study Director: Elena Parovichnikova,, MD,PhD, Nathional Medical Research Center for Hematology Moscow Russia 125167
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- r/r cHL-2022