PMID- 31661339 OWN - NLM STAT- MEDLINE DCOM- 20210428 LR - 20210428 IS - 1029-2403 (Electronic) IS - 1026-8022 (Linking) VI - 61 IP - 3 DP - 2020 Mar TI - Early induction intensification with cladribine, cytarabine, and mitoxantrone (CLAM) in AML patients treated with the DAC induction regimen: a prospective, non-randomized, phase II study of the Polish Adult Leukemia Group (PALG). PG - 588-603 LID - 10.1080/10428194.2019.1678151 [doi] AB - We present the results of a prospective, non-randomized phase 2 trial in which 253 AML patients (pts) under 60 years old received DAC (Daunorubicin + AraC + Cladribine) as first induction followed by CLAM (Cladribine + AraC + Mitoxantrone) as early second induction on day 16 based on bone marrow (BM) blasts on day 14 (D14). The CR/CRi rate after a single course of DAC was 83% for pts with D14 BM blasts less than 10%. Forty-six pts had >10% BM blasts on D14, of whom 35 received CLAM with rates of CR/CRi 60% and early death (ED) 23%. The remaining 11 pts were not fit to receive CLAM, with rates of CR/CRi 28%, PR 18%, and ED 18%. Median OS was 7.2 versus 7.5 months, respectively. The overall CR/CRi rate was 77% after the first induction, with final CR/CRi rate 80% after DAC reinduction for pts who achieved PR with initial DAC course. CLAM used as early second induction might improve CR/CRi rates for younger AML pts with poor early response to DAC induction, but may be associated with higher mortality. FAU - Pluta, Agnieszka AU - Pluta A AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. FAU - Robak, Tadeusz AU - Robak T AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. FAU - Brzozowski, Kamil AU - Brzozowski K AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. FAU - Stepka, Konrad AU - Stepka K AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. FAU - Wawrzyniak, Ewa AU - Wawrzyniak E AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. FAU - Krawczynska, Anna AU - Krawczynska A AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. FAU - Czemerska, Magdalena AU - Czemerska M AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. FAU - Szmigielska-Kaplon, Anna AU - Szmigielska-Kaplon A AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. FAU - Grzybowska-Izydorczyk, Olga AU - Grzybowska-Izydorczyk O AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. FAU - Nowicki, Mateusz AU - Nowicki M AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. FAU - Stelmach, Piotr AU - Stelmach P AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. FAU - Kuydowicz, Marta AU - Kuydowicz M AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. FAU - Gromek, Tomasz AU - Gromek T AD - Department of Hematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland. FAU - Hus, Marek AU - Hus M AD - Department of Hematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland. FAU - Helbig, Grzegorz AU - Helbig G AD - Department of Hematology and BMT, Medical School of Silesia, Katowice, Poland. FAU - Grosicki, Sebastian AU - Grosicki S AD - Department of Cancer Prevention, School of Public Health, Medical University of Silesia, Katowice, Poland. FAU - Bodzenta, Ewa AU - Bodzenta E AD - Department of Hematology, Municipal Hospital, Chorzow, Poland. FAU - Razny, Malgorzata AU - Razny M AD - Hematology Department, Rydygier Memorial Hospital, Krakow, Poland. FAU - Wojcik, Karol AU - Wojcik K AD - Hematology Department, Rydygier Memorial Hospital, Krakow, Poland. FAU - Bolkun, Lukasz AU - Bolkun L AD - Department of Hematology, Medical University Hospital, Bialystok, Poland. FAU - Kloczko, Janusz AU - Kloczko J AD - Department of Hematology, Medical University Hospital, Bialystok, Poland. FAU - Knopinska-Posluszny, Wanda AU - Knopinska-Posluszny W AD - Hematology Department, Hospital MSWiA, Olsztyn, Poland. FAU - Piekarska, Agnieszka AU - Piekarska A AD - Department of Hematology, Transplantation Medical University of Gdansk, Gdansk, Poland. FAU - Hellman, Andrzej AU - Hellman A AD - Department of Hematology, Transplantation Medical University of Gdansk, Gdansk, Poland. FAU - Sobas, Marta AU - Sobas M AUID- ORCID: 0000-0003-0781-8668 AD - Department of Hematology, Blood Neoplasm and Bone Marrow Transplantation, Wroclaw, Poland. FAU - Wrobel, Tomasz AU - Wrobel T AD - Department of Hematology, Blood Neoplasm and Bone Marrow Transplantation, Wroclaw, Poland. FAU - Patkowska, Elzbieta AU - Patkowska E AD - Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland. AD - Department of Hematology and Transfusion Medicine, Centre of Postgraduate Medical Education, Warsaw, Poland. FAU - Lech-Maranda, Ewa AU - Lech-Maranda E AD - Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland. AD - Department of Hematology and Transfusion Medicine, Centre of Postgraduate Medical Education, Warsaw, Poland. FAU - Warzocha, Krzysztof AU - Warzocha K AD - Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland. FAU - Holowiecki, Jerzy AU - Holowiecki J AD - Department of Bone Marrow Transplantation and Onco-Hematology, Maria Sklodowska-Curie Institute - Cancer Center, Gliwice Branch, Gliwice, Poland. FAU - Giebel, Sebastian AU - Giebel S AD - Department of Bone Marrow Transplantation and Onco-Hematology, Maria Sklodowska-Curie Institute - Cancer Center, Gliwice Branch, Gliwice, Poland. FAU - Wierzbowska, Agnieszka AU - Wierzbowska A AD - Department of Hematology, Medical University of Lodz, Lodz, Poland. LA - eng SI - ClinicalTrials.gov/NCT02072811 PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20191029 PL - United States TA - Leuk Lymphoma JT - Leukemia & lymphoma JID - 9007422 RN - 04079A1RDZ (Cytarabine) RN - 47M74X9YT5 (Cladribine) RN - BZ114NVM5P (Mitoxantrone) SB - IM MH - Adult MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - *Cladribine/therapeutic use MH - Cytarabine/therapeutic use MH - Humans MH - *Leukemia, Myeloid, Acute/drug therapy MH - Middle Aged MH - Mitoxantrone/therapeutic use MH - Poland MH - Prospective Studies MH - Remission Induction OTO - NOTNLM OT - AML OT - CLAM OT - early second induction EDAT- 2019/10/30 06:00 MHDA- 2021/04/29 06:00 CRDT- 2019/10/30 06:00 PHST- 2019/10/30 06:00 [pubmed] PHST- 2021/04/29 06:00 [medline] PHST- 2019/10/30 06:00 [entrez] AID - 10.1080/10428194.2019.1678151 [doi] PST - ppublish SO - Leuk Lymphoma. 2020 Mar;61(3):588-603. doi: 10.1080/10428194.2019.1678151. Epub 2019 Oct 29.