A Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma
NCT ID: NCT04981899
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2021-03-01
2024-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Main arm
Patients will receive 6 cycles of nivolumab at the fixed dose of 40 mg, with subsequent assessment of response by PET-CT. Patients with CR will proceed to ASCT.
Patients with \<CR after nivolumab monotherapy will be treated with 2 cycles of a combination of nivolumab at the fixed dose 40 mg, ifosfamide, carboplatin and etoposide (NICE-40), with subsequent PET-CT assessment.
Nivolumab
6 infusions of nivolumab at a fixed dose of 40 mg, 14 days apart, and infusion of nivolumab on day 0 of the NICE-40.
Ifosfamide
5000 mg / m2, 24-hour infusion on day 2 of the NICE-40.
Carboplatin
Optimized to get AUC = 5 (max. 800 mg) on day 2 of the NICE-40.
Etoposide
100 mg / m2 intravenously on 1-3 days of the NICE-40.
Interventions
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Nivolumab
6 infusions of nivolumab at a fixed dose of 40 mg, 14 days apart, and infusion of nivolumab on day 0 of the NICE-40.
Ifosfamide
5000 mg / m2, 24-hour infusion on day 2 of the NICE-40.
Carboplatin
Optimized to get AUC = 5 (max. 800 mg) on day 2 of the NICE-40.
Etoposide
100 mg / m2 intravenously on 1-3 days of the NICE-40.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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St. Petersburg State Pavlov Medical University
OTHER
Responsible Party
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Ivan S Moiseev
Vice-director for science RM Gorbacheva Institute
Principal Investigators
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Alexander Kulagin, MD,PhD
Role: STUDY_DIRECTOR
RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
Locations
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National Medicine Research Center of oncology named after N.N. Petrov
Saint Petersburg, Pesochny, Russia
Irkutsk Regional Cancer Center
Irkutsk, , Russia
St. Petersburg State Pavlov Medical University
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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r/r cHL NICE-40
Identifier Type: -
Identifier Source: org_study_id
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