ISSN 1866-8836
Клеточная терапия и трансплантация

Change template to: announce
Volume 6, Number 4
12/27/2017 10:03:02 pm
Volume 6, Number 4
Editor-in-Chief
Afanasyev B. V. (St. Petersburg, Russia)
Co-Editors-in-Chief
Wagemaker G. (Rotterdam, Netherlands)
Zander A.R. (Hamburg, Germany)
Deputy Editor
Fehse B. (Hamburg, Germany)
Managing Editor
Chukhlovin A. B. (St. Petersburg, Russia)
Editorial Board
Aleynikova O. V. (Minsk, Belarus)
Borset M. (Trondheim, Norway)
Chechetkin A. V. (St. Petersburg, Russia)
Fibbe W. (Leiden, Netherlands)
Galibin O. V. (St. Petersburg, Russia)
Hölzer D. (Frankfurt a.M., Germany)
Klimko N. N. (St. Petersburg, Russia)
Kolb H.-J. (München, Germany)
Kröger N. (Hamburg, Germany)
Kulagin A. D. (St. Petersburg, Russia)
Lange C. (Hamburg, Germany)
Mamaev N. N. (St. Petersburg, Russia)
Mikhailova N. B. (St. Petersburg, Russia)
Moiseev I. S. (St. Petersburg, Russia)
Nagler A. (Tel-Aviv, Israel)
Nemkov A. S. (St. Petersburg, Russia)
Paramonov I. V. (Kirov, Russia)
Roumiantsev A. G. (Moscow, Russia)
In this Issue

Current issue begins with a review article by Prof. Rüdiger Hehlmann dedicated to modern strategies of chronic myeloid leukemia treatment (CML) and the role of HSCT, which suffi ciently changed upon introduction of tyrosine kinase inhibitors. His considerations are mostly based on the results of the big CML Study IV, concerning imatinib dosage, or combined therapy with imatinib and cytarabine or interferon α in newly diagnosed patients in chronic phase. The issues of stopping imatinib therapy are discussed.

In his article, Prof. Axel R.Zander considers indications for HSCT in a clinically heterogenous group of chronic myeloproliferative diseases. Distinct molecular defects discovered over last decades are now subjected to specifi c targeted therapy which provides long-term remission states in most patients with chronic myeloid leukemia, primary myelofibrosis, however, using allogeneic HSCT in advanced and high-risk cases.

Some controversies occurring during selection of acute myeloblastic leukemia patients for alo-HSCT are critically evaluated by Prof. Robert P. Gale. To his opinion, the previously used and newer statistic approaches are not accurate enough to predictably discriminate high-risk patients, even if based on the known risk factors of the patients and individual tumor biology.

Dr. Marina O. Popova et al., describe their clinical experience with HIV-infected lymphoma patients treated by autologous HSCT, survival and relapse rate at 12 months aft er transplantation. The matched case-control study was performed at a single institution, (CIC725 EBMT center) designed to prospectively evaluate the safety and efficiency of ASCT for the patients with HIV-related lymphoma.

Another original article is presented by Dr. Ivan S. Moiseev and co-authors, being dedicated to intensively studied cyclophosphamide (Cy) treatment for the graft -versus-host disease. Its comparison with calcineurin inhibitor-based prophylaxis shows distinct benefi t of Cy therapy with respect to the main clinical HSCT outcomes and results.

A clinical case of common variable immunodefi ciency (CVID) and the main approaches to its diagnostics are described in a report by Dr. Andrey V. Kozlov et al. A number of immunological and genetic tests were performed, including new-generation sequencing provided several recognized clinical criteria for the CVID diagnostics.

The items discussed in the article by Prof. Alexander S. Nemkov and Yi Zhang concern probable role of endothelial dysfunction in cardiac disease and potential long-term favorable effects of intracoronary administration of the bone marrow mononuclear cells.

T is CTT issue also contains a synopsis of Regional clinical protocol for Hodgkin’s disease treatment using PET-assisted control and novel targeted drugs (Boris V. Afanasyev et al.). This protocol is endorsed by the leading clinical specialists from St. Petersburg.

For Russian readers, the full text of the multicenter observational program for the North-Western Russia is published in Russian language as well.

Editorial article

Editorial article
Professor Boris V.Afanasyev, Editor-in-Chief, Cellular Th erapy and Transplantation
Professor Axel R. Zander (Germany), Co-Editor-in Chief, CTT Journal
Professor Gerard Wagemaker (Netherlands), Co-Editor-in Chief, CTT Journal

Comment

Review articles

Clinical studies

Autologous hematopoietic cell transplantation for HIV-related lymphoma: results of a single center (CIC725) matched case-control study
Marina O. Popova, Yulia A. Rogacheva, Anastasia V. Nekrasova, Ivan V. Tsygankov, Ali Basahel, Kirill V. Lepik, Olga V. Pirogova, Elena I. Darskaya, Lilia V. Stelmakh, Yurii R. Zalyalov, Ivan S. Moiseev, Sergey N. Bondarenko, Natalia B. Mikhailova, Boris V. Afanasyev
Single-agent post-transplantation cyclophosphamide versus calcineurin-based graft-versus-host disease prophylaxis in matched related bone marrow transplantation
Ivan S. Moiseev1,2, Olga V. Pirogova1, Elena V. Babenko1, Tatyana L. Gindina1, Elena I. Darskaya1, Elena V. Morozova1,2, Sergey N. Bondarenko1, Boris V. Afanasyev1,2

Case report

Common variable immunodeficiency in a child. A case report
Andrey V. Kozlov, Tatiana A. Bykova, Anastasia S. Borovkova, Maria Yu. Averjanova, Varvara N. Ovechkina, Elena V. Morozova, Ludmila S. Zubarovskaya, Nikolay N. Mamaev, Boris V. Afanasyev

Experimental studies

Clinical trials

Multicenter prospective escalation-deescalation PET-guided clinical study in classical type Hodgkin disease in the North-West of Russian Federation (RNWOHG-HD1): rationale and design
Study authors: Boris V. Afanasyev1, Ivan S. Moiseev1, Sergey M. Alekseev2, Natalia B. Mikhailova1, Elena V. Kondakova1, Nikolai V. Ilyin3, Alexey M. Belyaеv2 Chief scientifi c advisors: Boris V. Afanasyev1, Sergey M. Alekseev2, Ivan S. Moiseev1 Supervisory board: Alexey M. Belyaеv2, Andrey Yu. Zaritskey4, Nikolai V. Ilyin3, Natalia B. Mikhailova1,
Nadejda V. Medvedeva5, Georgii M. Manikhas6, Sergey V. Voloshin7, Vladimir M. Moiseenko8, Tatyana V. Shneider9

Clinical protocol

Editorial article

Editorial article

Download PDF version

Professor Boris V.Afanasyev, Editor-in-Chief, Cellular Th erapy and Transplantation
Professor Axel R. Zander (Germany), Co-Editor-in Chief, CTT Journal
Professor Gerard Wagemaker (Netherlands), Co-Editor-in Chief, CTT Journal

Dear CTT authors and reviewers,
First of all, we would like to express our deep gratitude for your work on preparing and submitting your papers to our Journal as well as for reviewing the submissions, thus providing an important support to the CTT Journal over last years. Moreover, the Editors express a hope that this co-operation will be more advanced with time, expanding the membership of specialists publishing their data in CTT, both from Russia and abroad.
Publication in this journal is a great opportunity for the Russian as well as international specialists to publish Scopuscited research in English. The Journal provides fast and adequate peer reviewing, language editing and summaries in Russian to broaden the readers’ audience.
The Journal focuses on both preclinical and clinical aspects of cellular therapy and transplantation. In spite of numerous targeted drugs implemented over last years, e.g., PD-1 modulators, novel kinase inhibitors, monoclonal antibodies, gene therapy approaches, which have now changed the therapeutic landscape in hematology/oncology, the role of allogeneic hematopoietic stem cell transplantation (HSCT) is not diminishing, but rapidly growing, because more patients become eligible due to improvement of the disease status after targeted therapy, and more patients have long-term disease control due to disease-specifi c prophylaxis or pre-emptive strategies aft er transplantation. Thus the Journal welcomes articles addressing various aspects of improving the outcome after HSCT, including pre- and post-transplant therapy, conditionin regimens, and graft -versus-host-disease prophylaxis.
Another focus of the journal is on preclinical studies, because HSCT is now becoming the backbone of gene therapy, drug delivery strategies and immunotherapy. We welcome the researchers with their results on in vitro models that evaluate the efficacy of gene editing, immunological aspects of cancer therapy and novel approaches to antineoplastic drug delivery.
Hence, we wish much success in your studies, being in more close cooperation with Russian colleagues and the CTT Journal, which is ready to publish novel and original results in clinical and experimental cellular therapy.

Comment

Transplants for аcute myeloid leukaemia in 1st remission: statisticians, magicians and the rest of us

Download PDF version

Robert P. Gale MD, PhD DSc(hc), FACP, FRSM

Haematology Research Centre, Division of Experimental Medicine, Department of Medicine, Imperial College London, London, UK SW7 2AZ
The article concerns multiple factors infl uencing selection of patients with acute myeloid leukemia (AML) for hematopoietic stem cell transplantation. A number of prognostic and predictive variables may determine better probability of AML relapse, i.e., ROC analysis, thus allowing more accurate evaluation expressed in terms of concordance, or C-statistics. Th e fi nal results are, however, subject to unexplainable variance.

Keywords

Hematopoietic stem cell transplantation, acute myeloid leukemia, relapse risk, treatment options, statistics, ROC analysis.

Review articles

Opportunistic microflora at unusual sites: marker pathogens in severe posttransplant immune deficiency

Download PDF version

Alexey B. Chukhlovin1, Olga S. Pankratova2

1R. Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantology, Th e First St. Petersburg State I. Pavlov Medical University, St. Petersburg, Russia
2Tampere University Hospital, Tampere, Finland

Early severe immune suppression occurs aft er cytoreductive cancer treatment, especially, following conditioning therapy and hematopoietic stem cell transplantation (HSCT). Posttransplant recovery of immune response proceeds slowly, in particular, for the lymphocyte subsets. At later terms, immunosuppressive drugs promote the immune defi ciency state. Therefore, HSCT is associated with activation of diff erent endogenous infections. In most instances, the infectious complications are caused by opportunistic microorganisms (bacteria, fungi and viruses) which normally inhabit skin, mucosae etc. Th eir post-treatment proliferation and migration may occur to normally non-involved body areas (blood flow, bronchoalveolar areas, urinary pathways, skin dermal layers, lymph nodes, etc.). Hence, the early posttransplant activation of latent pathogens may be detected in peripheral blood, cerebrospinal fluid, ronchoalveolar lavage, saliva, urine and other samples being normally protected by immune system. The number of infectious species found in the same patient also correlates with higher posttransplant mortality.
Therefore, diagnostics of common immune defi ciency markers aft er intensive cytoreductive chemotherapy could be combined with a search for opportunistic infections at the normally non-infected sites (peripheral blood, saliva, urine) as well as aff ected mucosal surfaces (sputum, bronchial secretions, cerebrospinal fl uid). Several validated diagnostic panels (mostly multiplex PCR) were developed, in order to detect and assess number of infectious markers (viral, fungal and bacterial) in the patient. Th ey could be applied for more specific evaluation of immune defi ciency grade.

Keywords

Cytoreductive therapy, immune defi ciency, bacteria, viruses, activation, expansion, multiple infections, marker microorganisms.

Review articles

Stem cell transplantation for myeloproliferative diseases in the era of molecular therapy

Download PDF version

Axel R. Zander

Huntsman Cancer Institute, University of Utah, USA

A sufficient part of allo-HSCT is now performed for myelodysplastic syndromes and myeloproliferative neoplasms (MPN), whereas chronic myeloid leukemia is mostly treated by tyrosine kinase inhibitors (TKI). In some special situations, the reasons for allo-SCT in CML are as follows: TKI toxicity; resistance to common drug therapy, and advanced disease (accelerated phase or blast crisis). However, an improvement in progression-free survival may be obtained in advanced CML aft er haploidentical allo-HSCT versus graft ing from HLA-matched related/unrelated donors.
When planning therapy of primary myelofi brosis, one should take into account variable clinical course of the disease using, e.g., Lille scoring system which provides some prognostic criteria, molecular genetic markers, especially, overexpression of JAK2 gene thus allowing usage of ruxolitinib. Allo-SCT can cure myelofi brosis patients transformed to leukemia. In cases of relapse, a 2nd allo-HSCT or donor lymphocyte infusion may result into prolonged survival of the patients.
Results in chronic myelomonocytic leukemia patients treated with allo-HSCT depend on the pre-transplant risk scores. Patients transplanted in CR had signifi cantly longer relapse-free survival and signifi cantly longer overall survival. Early transplants were associated with higher survival rates. In cases of atypical CML, early allogeneic transplant should be performed. Allo-SCT is a method of choice in advanced systemic mastocytosis. It is performed in cases associated with non-mast cell involvement; in aggressive systemic mastocytosis, and in mast cell leukemia.

Keywords

Myeloproliferative disorders, allogeneic hematopoietic stem cell transplantation, tyrosine kinase inhibitors, chronic myeloid leukemia, primary myelofi brosis, chronic myelomyelocytic leukemia, systemic mastocytosis.

Review articles

Long-term survival with CML with imatinib or transplantation as first-line treatment: Comparison of outcomes from CML Studies IIIA and IV

Download PDF version

Rüdiger Hehlmann

Mannheim Medical Faculty, Heidelberg University

With introduction of the tyrosine kinase inhibitor (TKI) imatinib, the treatment strategy of CML has profoundly changed. TKIs became the fi rst-line treatment of choice for CML competing with allogeneic hematopoietic stem cell transplantation (HCT). Variables to be considered in choosing TKIs for fi rst-line therapy are as follows: conventional risk score; cytogenetic fi ndings with majorroute additional chromosomal aberrations (ACA) at diagnosis, and high-risk ACA in the course of CML; comorbidities; treatment costs. In cases of refractoriness to imatinib, the 2nd line treatment options are: clinical response milestones; adherence to therapy; resistance mutations; clonal evolution; therapy intolerance; drug safety; health care setting.
CML Study IV, a randomized treatment study concerning imatinib dose optimization and combined therapy with imatinib and cytarabine or interferon α included 1551 newly diagnosed patients in chronic phase. The key outcome was no superiority of survival of any treatment option. Imatinib 400 mg provides close to normal life expectancy in chronic-phase CML patients. Survival is independent of time to response. Outcome of CML is currently more determined by disease and patients’ factors, e.g., comorbidities and smoking, and by center eff ects than by initial treatment selection. A comparison of long-term survival aft er HCT or imatinib treatment showed that low risk patients had similar survival with both options. Attempts at improving treatment should focus on subgroups of refractory disease e.g. by HCT, and on non-CML determinants of survival. After progression to blast crisis, HCT did not provide a signifi cant survival advantage, although a special study showed that most long-term survivors (72%) were patients who received a transplant. The 10-year deep molecular remission rates of 70%-80% indicate that the majority of imatinib-treated patients are candidates for treatment discontinuation.

Keywords

Chronic myeloid leukemia, tyrosine kinase inhibitors, imatinib, treatment strategy, hematopoietic stem cell transplantation, survival.

Clinical studies

Autologous hematopoietic cell transplantation for HIV-related lymphoma: results of a single center (CIC725) matched case-control study

Download PDF version

Marina O. Popova, Yulia A. Rogacheva, Anastasia V. Nekrasova, Ivan V. Tsygankov, Ali Basahel, Kirill V. Lepik, Olga V. Pirogova, Elena I. Darskaya, Lilia V. Stelmakh, Yurii R. Zalyalov, Ivan S. Moiseev, Sergey N. Bondarenko, Natalia B. Mikhailova, Boris V. Afanasyev

R. Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation, Chair of Hematology, Transfusiology and Transplantation, Th e St. Petersburg First State Medical I. Pavlov University (CIC725)

Human immunodefi ciency virus (HIV) infection is associated with an increased incidence of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). Throughout the HAART era, autologous stem cell transplantation (ASCT) has been reported as a feasible, safe, and useful approach to either rescue or consolidate HIV-related lymphoma patients. However, the number of published comparative studies according to the HIV status is limited. Th e aim of the study was to estimate the early safety and effi cacy of high-dose chemotherapy followed by autologous hematopoietic cell transplantation in HIV-related lymphoma. Since the Jan 2016 seven patients with HIV-related lymphoma who have undergone ASCT were included in the prospective singe centre study (study group – HIV group, n=7). T e data of the non-HIV-infected patients with lymphoma who have undergone ASCT at the same period of time (control group, n=28) were collected to compare the efficacy and safety of the procedure (ratio 1:4). Median follow up time was 12 (1-20) months in study group and 8 (1-20) months in control group. The primary endpoint was overall survival (OS) at 12 months after ASCT. Secondary end points were hematopoietic recovery and organ toxicity, progression free survival (PFS) and relapse rate at 12 months aft er ASCT. Here we report the early results of a single institution (EBMT center CIC725) matched case-control study. Th is was an observation trial designed to prospectively evaluate the safety and eff ectiveness of ASCT for patients with HIV-related lymphoma. One-year overall survival in patients with HIV-related lymphoma was 100%, the probability of PFS – 85,7%, relapse rate – 14,3% and did not diff er from the control group. There were not found statistical signifi cant diff erences between two groups in hematopoietic recovery and toxicity rate. Preliminary data provide further evidence that HIV status does not affect the outcome of ASCT for lymphoma, and therefore HIV status alone should no longer exclude these patients from transplant clinical trials.

Keywords

Autologous hematopoietic cell transplantation, HIV, HIV-related lymphoma, high-dose chemotherapy, non-Hodgkin lymphoma, Hodgkin lymphoma, matched case-control study.

Clinical studies

Single-agent post-transplantation cyclophosphamide versus calcineurin-based graft-versus-host disease prophylaxis in matched related bone marrow transplantation

Download PDF version

Ivan S. Moiseev1,2, Olga V. Pirogova1, Elena V. Babenko1, Tatyana L. Gindina1, Elena I. Darskaya1, Elena V. Morozova1,2, Sergey N. Bondarenko1, Boris V. Afanasyev1,2

1R. M. Gorbacheva Memorial Institute of Children Hematology, Oncology and Transplantation, Pavlov First Saint Petersburg State Medical University
2Chair of Hematology, Transfusiology and Transplantation, Pavlov First St. Petersburg State Medical University, St. Petersburg, Russian Federation

A number of studies were published demonstrating efficacy of single-agent graft-versus-host disease prophylaxis (GVHD) with post-transplantation cyclophosphamide (saPTCy) in matched related bone marrow transplantations (BMT), however no comparisons were published so far between saPTCy and conventional GVHD prophylaxis based on calcineurin inhibitors (CNIs). In this study, 78 patients graft ed with bone marrow from matched related donor (MRD) with saPTCy GVHD prophylaxis were compared to 105 historical control patients also receiving bone marrow from MRD, but with tacrolimus/cyclosporine A and mycophenolate mofetil/methotrexate prophylaxis. Groups were comparable in pre-transplant characteristics of patients, except higher prevalence of salvage patients and acute lymphoblastic leukemia in CNIs cohort. PTCy was superior to CNIs in prevention of grade II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) and grade III-IV acute GVHD (HR 0.192, 95% CI 0.055-0.666, p=0.009), relapse (HR 0.519, 95% CI 0.297-0.893, p=0.023). No difference was observed for moderate and severe chronic GVHD (HR 0.898, 95% CI 0.477-1.69, p=0.74) and non-relapse mortality (HR 0.384, 95% CI 0.089-1.437, p=0.1768). Patients after saPTCy had improved overall survival (HR 0.489, 95% CI 0.261-0.917, p=0.03), event-free-survival (HR 0.571, 95% CI 0.334-0.976, p=0.04) and GVHD-relapse-free survival (HR 0.493, 95% CI 0.309-0.786, p=0.003). Th e toxicity of BMT was generally comparable, except lower incidence of nephrotoxicity (33% vs 43%, p=0.008) aft er PTCy, but with higher incidence of grade 3-4 mucositis in this group (41% vs 34%, p=0.02). Despite limitations of single-center retrospective design, this study demonstrated superiority of saPTCy vs CNI-based prophylaxis, but these results should be confirmed in prospective randomized trials.

Keywords

Bone marrow transplantation, graft-versus-host disease, post-transplantation cyclophosphamide, prophylaxis.

Case report

Common variable immunodeficiency in a child. A case report

Download PDF version

Andrey V. Kozlov, Tatiana A. Bykova, Anastasia S. Borovkova, Maria Yu. Averjanova, Varvara N. Ovechkina, Elena V. Morozova, Ludmila S. Zubarovskaya, Nikolay N. Mamaev, Boris V. Afanasyev

R. Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantology, Chair of Hematology, Transfusiology and Transplantation, First St. Petersburg State I. Pavlov Medical University, St. Petersburg, Russia

Primary immunodefi ciency syndromes are relatively rare medical conditions that are oft en misdiagnosed because of unspecifi c clinical presentation that mimics other more common diseases. Incidence of combined common variable immunodefi ciency (CVID) is ca. 1 case per 30.000 European population. Usually, a delay of several years is observed between onset and diagnosis. CVID is the most frequent primary immunodefi ciency aft er 4 years of life. The key symptom to establish the disorder is hypogammaglobulinemia.
The aim of this article is to demonstrate current trends in diagnostics of common variable immunodefi ciency (CVID). The present case report describes a 10-year old girl with four major internationally approved criteria of common variable immunodefi ciency (CVID), and specific lung involvement. Malignant conditions were excluded. NGS genetic study did not detect any gene mutation which could be responsible for CVID or related syndromes (ALPS, HLH). Hence, the CVID remains a diagnosis of exclusion. Despite replacement with intravenous immunoglobulins, the lung function in our patient continued to deteriorate that necessitated initiation of immunosuppressive treatment.

Keywords

Primary immunodefi ciency, common variable immunodeficiency, diagnostic criteria, autoimmune complications.

Experimental studies

Does the local coronary endothelial dysfunction exist? Potential implications for cardiac cellular therapy

Download PDF version

Alexander S. Nemkov, Zhang Yi

First St. Petersburg State I. Pavlov Medical University, St. Petersburg, Russia

Endothelium is a cellular layer lining blood vessels in either a human organ or tissue. For decades, protective and barrier functions were considered to be the main property of vascular endothelium. Over last 20 years, however, endothelium is also considered an active endocrine organ which, due to secretion of multiple enzymes, metabolic and growth factors, may exert suffi cient regulatory effects upon heart and blood vessels, thus playing an important role in pathogenesis of certain cardiovascular disorders. Accumulating data on changing interactions between heart vascular endothelium and myocardium allow us to suggest an additional local function for coronary endothelium, i.e., a proposed production of biologically active substances by endothelial cells, and their eff ects upon metabolism, functioning, survival and regeneration of cardiomyocytes. The discussion article presents analysis of distinct studies concerning cellular therapy in human heart diseases. These data are favoring a hypothesis about additional role of endothelium in cardiac function, and offer a potential ability to correct endothelial dysfunction by means of cellular therapy.

Keywords

Heart, coronary artery disease, endothelial dysfunction, cellular therapy, dilated cardiomyopathy.

Clinical trials

Multicenter prospective escalation-deescalation PET-guided clinical study in classical type Hodgkin disease in the North-West of Russian Federation (RNWOHG-HD1): rationale and design

Download PDF version

Study authors: Boris V. Afanasyev1, Ivan S. Moiseev1, Sergey M. Alekseev2, Natalia B. Mikhailova1, Elena V. Kondakova1, Nikolai V. Ilyin3, Alexey M. Belyaеv2 Chief scientifi c advisors: Boris V. Afanasyev1, Sergey M. Alekseev2, Ivan S. Moiseev1 Supervisory board: Alexey M. Belyaеv2, Andrey Yu. Zaritskey4, Nikolai V. Ilyin3, Natalia B. Mikhailova1,
Nadejda V. Medvedeva5, Georgii M. Manikhas6, Sergey V. Voloshin7, Vladimir M. Moiseenko8, Tatyana V. Shneider9

1R. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation, Pavlov First St. Petersburg State Medical University, St. Petersburg, Russian Federation
2Prof. N. N. Petrov Research Institute of Oncology, St. Petersburg, Russian Federation
3Central Research Institute of X-ray and Radiation Studies, Ministry of Health of the Russian Federation, St. Petersburg, Russia 4Oncohaematology Department, Almazov Federal Heart, Blood and Endocrinology Centre, St. Petersburg, Russia
5St. Petersburg City Hospital №31, St. Petersburg, Russian Federation
6St. Petersburg City Clinical Oncology Dispensary, St. Petersburg, Russian Federation
7Russian Research Institute of Hematology and Transfusiology, St. Petersburg, Russia
8St. Petersburg Oncological Center, St. Petersburg, Russia
9Leningrad District Clinical Hospital, St. Petersburg, Russia

Currently there is no established standard of care for Hodgkin’s disease (HD) in Russian Federation (RF). The mortality from HD in RF is 28,3%, thus improvement of care is required. Here we describe the design and the rational for the fi rst cooperative prospective study in the Nort-West region of RF, RNWOHG-HD1. The key points of the protocol are discussed, including escalation from ABVD to BEACOPPesc in case of PET-positive disease aft er fi rst two cycles in the favorable prognosis group, and de-escalation to randomized ABVD/AVD in case of PET(-) status aft er fi rst two BEACOPPesc courses in the unfavorable prognosis group. The protocol also is planned to facilitate access to second and third line treatments, including brentuximab, as well as autologous and allogeneic stem cell transplantation.

Keywords

Hodgkin’s disease, multicenter study, positron emission tomography (PET), RNWOHG-HD1.

Clinical protocol

Multicenter cooperative prospectiveretrospective observational program for diagnostics and treatment of Hodgkin disease in the North-Western District of Russian Federation (RNWOHG-HD1 Protocol, the full-text version in Russian) 2nd part

Download PDF version

Clinical protocol

Multicenter cooperative prospectiveretrospective observational program for diagnostics and treatment of Hodgkin disease in the North-Western District of Russian Federation (RNWOHG-HD1 Protocol, the full-text version in Russian), 1st part

Download PDF version

Clinical protocol

Multicenter cooperative prospectiveretrospective observational program for diagnostics and treatment of Hodgkin disease in the North-Western District of Russian Federation (RNWOHG-HD1 Protocol, the full-text version in Russian) 3rd part