Combination of Nivolumab and DHAP in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP)
NCT ID: NCT04091490
Last Updated: 2023-09-21
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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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2020-02-19
2022-12-31
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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Patients with relapsed/refractory Hodgkin's lymphoma
A clinical study of safety and efficacy of treatment with Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma
Nivolumab
Combination of 2 cycles of Nivolumab as a monotherapy with 4 cycles of high-dose chemotherapy (DHAP chemoregimen) with Nivolumab
Interventions
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Nivolumab
Combination of 2 cycles of Nivolumab as a monotherapy with 4 cycles of high-dose chemotherapy (DHAP chemoregimen) with Nivolumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
OTHER
Responsible Party
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Principal Investigators
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Vladislav Sarzhevskiy, PhD
Role: PRINCIPAL_INVESTIGATOR
National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
Locations
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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
Countries
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References
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Sasse S, Alram M, Muller H, Smardova L, Metzner B, Doehner H, Fischer T, Niederwieser DW, Schmitz N, Schafer-Eckart K, Raemaekers JM, Schmalz O, Tresckow BV, Engert A, Borchmann P. Prognostic relevance of DHAP dose-density in relapsed Hodgkin lymphoma: an analysis of the German Hodgkin-Study Group. Leuk Lymphoma. 2016 May;57(5):1067-73. doi: 10.3109/10428194.2015.1083561. Epub 2015 Dec 23.
Armand P, Engert A, Younes A, Fanale M, Santoro A, Zinzani PL, Timmerman JM, Collins GP, Ramchandren R, Cohen JB, De Boer JP, Kuruvilla J, Savage KJ, Trneny M, Shipp MA, Kato K, Sumbul A, Farsaci B, Ansell SM. Nivolumab for Relapsed/Refractory Classic Hodgkin Lymphoma After Failure of Autologous Hematopoietic Cell Transplantation: Extended Follow-Up of the Multicohort Single-Arm Phase II CheckMate 205 Trial. J Clin Oncol. 2018 May 10;36(14):1428-1439. doi: 10.1200/JCO.2017.76.0793. Epub 2018 Mar 27.
Josting A, Rudolph C, Reiser M, Mapara M, Sieber M, Kirchner HH, Dorken B, Hossfeld DK, Diehl V, Engert A; Participating Centers. Time-intensified dexamethasone/cisplatin/cytarabine: an effective salvage therapy with low toxicity in patients with relapsed and refractory Hodgkin's disease. Ann Oncol. 2002 Oct;13(10):1628-35. doi: 10.1093/annonc/mdf221.
Other Identifiers
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Nivo-DHAP-cHL-1
Identifier Type: -
Identifier Source: org_study_id
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