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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">bloodjour</journal-id><journal-title-group><journal-title xml:lang="ru">Гематология и трансфузиология</journal-title><trans-title-group xml:lang="en"><trans-title>Russian journal of hematology and transfusiology</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">0234-5730</issn><issn pub-type="epub">2411-3042</issn><publisher><publisher-name>ООО Издательский дом «Практика»</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.25837/HAT.2019.92.27.001</article-id><article-id custom-type="elpub" pub-id-type="custom">bloodjour-102</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОРИГИНАЛЬНЫЕ СТАТЬИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ORIGINAL ARTICLES</subject></subj-group></article-categories><title-group><article-title>ЛЕЧЕНИЕ ОСТРЫХ ЛИМФОБЛАСТНЫХ ЛЕЙКОЗОВ У БЕРЕМЕННЫХ ПО ПРОТОКОЛУ ОЛЛ-2009</article-title><trans-title-group xml:lang="en"><trans-title>TREATMENT OF ACUTE LYMPHOBLASTIC LEUKEMIA DURING PREGNANCY ACCORDING TO THE ALL-2009 PROTOCOL</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-4827-8947</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Троицкая</surname><given-names>В. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Troitskaya</surname><given-names>V. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, заведующая отделением высокодозной интенсивной химиотерапии гемобластозов и депрессий кроветворения</p></bio><bio xml:lang="en"><p>MD, PhD, Head of the Department of High-Dose Intensive Chemotherapy of Leukemia and Depression of hematopoiesis,</p><p>Moscow</p></bio><email xlink:type="simple">troitskaya.v@blood.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-6177-3566</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Паровичникова</surname><given-names>Е. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Parovichnikova</surname><given-names>E. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>доктор медицинских наук, заведующая отделом высокодозной интенсивной химиотерапии гемобластозов, депрессий кроветворения и трансплантации костного мозга</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">elenap@blood.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-1494-7978</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Соколов</surname><given-names>А. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Sokolov</surname><given-names>A. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, старший научный сотрудник отдела высокодозной интенсивной химиотерапии гемобластозов, депрессий кроветворения и трансплантации костного мозга</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">cat@blood.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-0261-5941</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кохно</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Kokhno</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, ведущий научный сотрудник отдела высокодозной интенсивной химиотерапии гемобластозов, депрессий кроветворения и трансплантации костного мозга</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">anilaco@rambler.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8818-8949</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Галстян</surname><given-names>Г. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Galstyan</surname><given-names>G. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>доктор медицинских наук, заведующий отделением реанимации и интенсивной терапии</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">gengalst@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9969-8482</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гаврилина</surname><given-names>О. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Gavrilina</surname><given-names>O. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, старший научный сотрудник отдела высокодозной интенсивной химиотерапии гемобластозов, депрессий кроветворения и трансплантации костного мозга</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">dr.gavrilina@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-0934-6094</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Фидарова</surname><given-names>З. Т.</given-names></name><name name-style="western" xml:lang="en"><surname>Fidarova</surname><given-names>Z. T.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, старший научный сотрудник отдела высокодозной интенсивной химиотерапии гемобластозов, депрессий кроветворения и транс-плантации костного мозга</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">fzalinafidarova@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-0089-5476</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Лукьянова</surname><given-names>И. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Lukyanova</surname><given-names>I. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>врач отделения высокодозной интенсивной химиотерапии гемобластозов и депрессий кроветворения</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">lukyanova.i@blood.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9923-1711</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Махиня</surname><given-names>С. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Makhinya</surname><given-names>S. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, врач акушер-гинеколог</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">makhinya.s@blood.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3467-4236</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Латышкевич</surname><given-names>О. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Latyshkevich</surname><given-names>O. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, главный внештатный специалист по репродуктивному здоровью Департамента здравоохранения города Москвы;</p><p>главный врач;</p><p>врач акушер-гинеколог</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">latishkevich@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9632-6731</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Оленев</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Olenev</surname><given-names>A. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, главный внештатный специалист по акушерству и гинекологии Департамента здравоохранения города Москвы, заведующий филиалом «Перинатальный центр»</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">olenevAS@zdrav.mos.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-6201-6276</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кузьмина</surname><given-names>Л. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Kuzmina</surname><given-names>L. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, заведующая отделением химиотерапии гемобластозов и трансплантации костного мозга</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">kuzlara@rambler.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-5973-5763</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Клясова</surname><given-names>Г. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Klyasova</surname><given-names>G. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>доктор медицинских наук, профессор, заведующая научно-клинической лабораторией клинической бактериологии, микологии и антибиотической терапии</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">Klyasova.g@blood.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Капорская</surname><given-names>Т. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Kaporskaya</surname><given-names>T. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, заведующая гематологическим отделением</p></bio><bio xml:lang="en"><p>Irkutsk</p></bio><email xlink:type="simple">tsk2704@mail.ru</email><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Лапин</surname><given-names>В. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Lapin</surname><given-names>V. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>главный внештатный специалист-гематолог ДЗиФ Ярославской области, врач</p></bio><bio xml:lang="en"><p>Yaroslavl</p></bio><email xlink:type="simple">valapin0409@mail.ru</email><xref ref-type="aff" rid="aff-5"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сердюк</surname><given-names>О. Д.</given-names></name><name name-style="western" xml:lang="en"><surname>Serdyuk</surname><given-names>O. D.</given-names></name></name-alternatives><bio xml:lang="ru"><p>главный внештатный гематолог Министерства здравоохранения Краснодарского края, заведующая гематологическим отделением</p></bio><bio xml:lang="en"><p>Krasnodar</p></bio><email xlink:type="simple">7-18@mail.ru</email><xref ref-type="aff" rid="aff-6"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8044-598X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Чабаева</surname><given-names>Ю. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Chabaeva</surname><given-names>Yu. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>старший научный сотрудник информационно-аналитического отдела</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">uchabaeva@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6288-7570</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Куликов</surname><given-names>С. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Kulikov</surname><given-names>S. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат физико-технических наук, заведующий информационно-аналитическим отделом</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">kulikov@blood.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8188-5557</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Савченко</surname><given-names>В. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Savchenko</surname><given-names>V. G.</given-names></name></name-alternatives><bio xml:lang="ru"><p>академик РАН, доктор медицинских наук, профессор, Генеральный директор</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">director@blood.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБУ «НМИЦ гематологии» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>National Research Center for Hematology</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ГБУЗ города Москвы «Центр планирования семьи и репродукции Департамента здравоохранения города Москвы»;&#13;
ФГБУ «НМИЦ гематологии» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>National Research Center for Hematology;&#13;
Center for Family Planning and Reproduction</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>ГБУЗ «Городская клиническая больница № 24» Департамента здравоохранения города Москвы</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Affiliate No. 2 of the Moscow Municipal Clinical Hospital No. 24</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>ГБУЗ Иркутская ордена «Знак почета» областная клиническая больница</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Irkutsk Regional Clinical Hospital</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-5"><aff xml:lang="ru"><institution>ГБУЗ Ярославской области «Областная клиническая больница»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Yaroslavl Regional Clinical Hospital</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-6"><aff xml:lang="ru"><institution>ГБУЗ «Клинический онкологический диспансер №1» Министерства здравоохранения Краснодарского края</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Clinical Oncology Dispensary No. 1</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2018</year></pub-date><pub-date pub-type="epub"><day>06</day><month>06</month><year>2019</year></pub-date><volume>63</volume><issue>3</issue><fpage>209</fpage><lpage>230</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Троицкая В.В., Паровичникова Е.Н., Соколов А.Н., Кохно А.В., Галстян Г.М., Гаврилина О.А., Фидарова З.Т., Лукьянова И.А., Махиня С.А., Латышкевич О.А., Оленев А.С., Кузьмина Л.А., Клясова Г.А., Капорская Т.С., Лапин В.А., Сердюк О.Д., Чабаева Ю.А., Куликов С.М., Савченко В.Г., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Троицкая В.В., Паровичникова Е.Н., Соколов А.Н., Кохно А.В., Галстян Г.М., Гаврилина О.А., Фидарова З.Т., Лукьянова И.А., Махиня С.А., Латышкевич О.А., Оленев А.С., Кузьмина Л.А., Клясова Г.А., Капорская Т.С., Лапин В.А., Сердюк О.Д., Чабаева Ю.А., Куликов С.М., Савченко В.Г.</copyright-holder><copyright-holder xml:lang="en">Troitskaya V.V., Parovichnikova E.N., Sokolov A.N., Kokhno A.V., Galstyan G.M., Gavrilina O.A., Fidarova Z.T., Lukyanova I.A., Makhinya S.A., Latyshkevich O.A., Olenev A.S., Kuzmina L.A., Klyasova G.A., Kaporskaya T.S., Lapin V.A., Serdyuk O.D., Chabaeva Y.A., Kulikov S.M., Savchenko V.G.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.htjournal.ru/jour/article/view/102">https://www.htjournal.ru/jour/article/view/102</self-uri><abstract><sec><title>Введение</title><p>Введение. Диагностика острого лейкоза (ОЛ) во время беременности — крайне редкое событие, что ограничивает возможность проведения крупных проспективных исследований и сравнительных исследований по лечению этого заболевания у беременных. В 2009 г. Российская кооперированная группа по лечению ОЛ в рамках проспективного многоцентрового клинического исследования ОЛЛ-2009 приняла решение о возможности включения в исследование женщин, которым диагноз острого лимфобластного лейкоза (ОЛЛ) был установлен на различных сроках беременности. Это позволило оценить прогностическое значение беременности на момент диагностики ОЛЛ и провести сравнительный анализ переносимости и эффективности терапии по протоколу ОЛЛ-2009 у беременных.</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. С 2009 по 2017 год в многоцентровое клиническое исследование ОЛЛ-2009 (идентификационный номер ClinicalTrials.gov NCT01193933) было включено 15 беременных в возрасте 18—41 года (медиана 28 лет) с Ph-негативным ОЛЛ. Лечение 11 из 15 больных проводилось в ФГБУ «НМИЦ гематологии» Министерства здравоохранения России, остальных 4 больных — в региональных клиниках. При диагностике ОЛЛ в I  триместре беременность прерывали по медицинским показаниям (n  = 3). При диагностике ОЛЛ на 34—40-й  неделе беременности проводили родоразрешение до начала терапии (n = 3). При диагностике заболевания в II  триместре и на более ранних сроках III триместра терапию проводили во время беременности (n = 9). Был проведен сравнительный анализ выполняемости и токсичности химиотерапии по протоколу ОЛЛ-2009 у беременных и у молодых (до 30 лет) больных ОЛЛ в целом. Проанализировано влияние беременности на момент диагностики ОЛЛ на результаты терапии, для чего была сформирована группа сравнения из 127 женщин фертильного возраста (16—50 лет, медиана — 28 лет), лечение которых проводилось в рамках этого протокола. Для сравнения и обсуждения полученных результатов был выполнен метаанализ доступных литературных источников. Поиск публикаций в PubMed осуществлялся по ключевым словам «acute lymphoblastic leukemia» и «pregnancy».</p></sec><sec><title>Результаты</title><p>Результаты. При сравнительном анализе исходных клинико-лабораторных характеристик беременных и небеременных больных ОЛЛ у беременных статистически достоверно чаще выявлялся T-клеточный вариант ОЛЛ (53,3 и 26% соответственно), чем B-клеточный (46,7 и 69,3%, p  = 0,025). В отношении большинства других параметров и в отношении распределения больных по группам риска различий не было. Не было выявлено статистически значимых различий в продолжительности периодов нейтропении, в частоте и длительности интервалов (отклонений от протокола) в ходе индукции химиотерапии (ХТ) на фоне беременности в сравнении с общей популяцией больных ОЛЛ в возрасте до 30 лет. Однако у беременных в ходе первой фазы индукции ремиссии была выше потребность в трансфузиях компонентов крови, в частности концентрата тромбоцитов (77,8 и 46,6% случаев соответственно). При анализе результатов лечения показано, что наличие беременности на момент диагностики ОЛЛ не влияло на частоту достижения полной ремиссии (ПР) (86,7 и 85,8% соответственно). Не было выявлено также статистически достоверных отличий в частоте рефрактерных форм ОЛЛ (13,3 и 4,7% соответственно). Ранней смертности среди беременных не отмечено. При анализе долгосрочных результатов терапии также не найдено достоверных различий как в общей выживаемости (у женщин, которым ОЛЛ диагностирован во время беременности,  — 58,6%, у небеременных женщин  — 43,3%), так и в безрецидивной выживаемости (46 и 51% соответственно). Вероятность развития рецидива также была идентична (49 и 40,3% соответственно). В общей сложности на сроке беременности 34—38 недель (медиана 35 недель) рождено 12 детей (6 мальчиков и 6 девочек). В настоящее время все они здоровы и развиваются соответственно возрасту, медиана которого составляет 5 лет и 2 месяца (от 2 лет и 1 месяца до 8 лет и 10 месяцев).</p></sec><sec><title>Заключение</title><p>Заключение. По результатам данного исследования можно сделать вывод, что наличие беременности на момент диагностики ОЛЛ не оказало влияния не только на индукционные, но и на долгосрочные результаты терапии по протоколу ОЛЛ-2009. Приемлемая токсичность терапии, основанной на принципе постоянного низкодозного цитостатического воздействия, как для матери, так и для плода, позволяет полноценно реализовывать данный протокол у беременных женщин. </p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. Acute leukemias are very rarely diagnosed during pregnancy, which makes large prospective or comparative studies of treatment of leukemias during pregnancy difficult. In 2009, the Russian Acute Lymphoblastic Leukemia Study Group decided to include women diagnosed with acute lymphoblastic leukemia (ALL) during various stages of pregnancy into the ALL-2009 prospective clinical study to determine the predictive role of pregnancy at diagnosis, and to estimate efficacy and tolerance of the ALL-2009 protocol in pregnant women.</p></sec><sec><title>Materials and methods</title><p>Materials and methods. During the period of 2009– 2017, 15  pregnant women with Ph-negative ALL aged 18–41 (median 28) years were enrolled in the multicenter clinical trial ALL-2009 (NCT number NCT01193933). Eleven women were treated at the National Research Center for Hematology in Moscow; the other four were treated in Russian regional hospitals. In cases when ALL was diagnosed during the first trimester of pregnancy (n = 3), the pregnancy was terminated. If ALL was diagnosed at week 34–40 (n = 3), the baby was delivered before the beginning of therapy. If ALL was diagnosed during the second or early third trimester, the treatment was performed during pregnancy. We compared toxicity and tolerance of chemotherapy according to the ALL-2009 protocol in pregnant patients and in young (30 years and younger) ALL patients. We also compared the results of treatment of pregnant patients with the control group (127 women of fertile age: 16–50 years old, with a median of 28 years old) enrolled in the study. For discussion of the results, we did a meta-analysis of available publications (retrieved via PubMed using the keywords “acute lymphoblastic leukemia” and “pregnancy”).</p></sec><sec><title>Results</title><p>Results. There was a significantly higher frequency of T-cell ALL than of B-cell ALL (53.3% vs 46,7% compared to 26% vs 69,3% in the control group, p = 0.025). Other than that, there were no significant differences in clinical or laboratory data between the groups. No significant differences were found in the duration of neutropenia, or in the duration and frequency of breaks in chemotherapy compared with other patients below 30 enrolled in the study. However, during the first remission induction phase, pregnant patients required blood transfusions, specifically platelets, at a higher rate (77.8% vs 46.6% of cases). Results of the treatment were similar regardless of pregnancy at the time of diagnosis (86.7% of complete remissions, vs 85.8% in the control group). Differences in the frequency of refractory leukemia (13.3% vs 4.7%) were not statistically significant. There were no cases of early mortality. Long-term results were also similar, both in terms of overall survival (58.6% vs 43.3% in the control group) and in terms of disease-free survival (46% vs 51%). Relapse probability was the same (49% vs 40.3%). Overall, the pregnant patients gave birth to 12  children (6 boys and 6 girls) at weeks 34–38 (median 35 weeks) of pregnancy. At the time of writing, all children are healthy and are developing in accordance with their age, which ranges from 2 years 1 month to 8 years 10 months (median 5 years and 2 months).</p></sec><sec><title>Conclusion</title><p>Conclusion. The results of the study suggest that pregnancy at the time of diagnosis with ALL did not affect either the short-term or the long-term results of therapy according to the ALL-2009 protocol. The acceptable level of toxicity of the low-dose cytostatic therapy for both the mother and the child makes it possible to use the ALL-2009 protocol in treatment of pregnant patients.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>острый лимфобластный лейкоз</kwd><kwd>беременность</kwd><kwd>химиотерапия</kwd></kwd-group><kwd-group xml:lang="en"><kwd>acute lymphoblastic leukemia</kwd><kwd>pregnancy</kwd><kwd>chemotherapy</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Terek MC, Ozkinay E, Zekioglu O, Erhan Y, Cagirgan S, Pehlivan M et al. Acute leukemia in pregnancy with ovarian metastasis: a case report and review of the literature. Int J Gynecol Cancer. 2003;13:904—8.</mixed-citation><mixed-citation xml:lang="en">Terek MC, Ozkinay E, Zekioglu O, Erhan Y, Cagirgan S, Pehlivan M et al. 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