Remission and Survival after Single Versus Double Induction
with 7+3 for Newly Diagnosed Acute Myeloid Leukemia: Results
from the Planned Interim Analysis of Randomized Controlled
SAL-Daunodouble Trial

a 2020

Remission and Survival after Single Versus Double Induction with 7+3 for Newly Diagnosed Acute Myeloid Leukemia: Results from the Planned Interim Analysis of Randomized Controlled SAL-Daunodouble Trial

ROLLIG, C., B. STEFFEN, N. ALAKEL, R. HERBST, R. NOPPENEY et. al.

Basic information

Original name

Remission and Survival after Single Versus Double Induction with 7+3 for Newly Diagnosed Acute Myeloid Leukemia: Results from the Planned Interim Analysis of Randomized Controlled SAL-Daunodouble Trial

Authors

ROLLIG, C., B. STEFFEN, N. ALAKEL, R. HERBST, R. NOPPENEY, M. HANOUN, Z. RACIL, K. SCHAFER-ECKART, A. KRAMER, A. NEUBAUER, C. D. BALDUS, C. SCHLIEMANN, M. KAUFMANN, J. MERTOVA, E. JOST, D. NIEMANN, J. NOVAK, S. W. KRAUSE, S. SCHOLL, G. HELD, S. B. PARMENTIER, T. SZOTKOWSKI, P. ZAK, A. RANK, M. WASS, S. BUSKE, M. KRAMER, F. FIEBIG, A. HAAKE, J. SCHETELIG, U. PLATZBECKER, C. THIEDE, C. MULLER-TIDOW, W. E. BERDEL, H. SERVE, G. EHNINGER, Jiří MAYER (203 Czech Republic, guarantor, belonging to the institution) and M. BORNHAUSER

Edition

2020

Other information

Language

English

Type of outcome

Konferenční abstrakt

Field of Study

30230 Other clinical medicine subjects

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

Daunodouble

RIV identification code

RIV/00216224:14110/20:00123101

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1182/blood-2020-140246

UT WoS

000607205603028

Keywords (in Czech)

Daunodouble; klinické hodnocení; Akutní myeloidní leukémie; cytarabine; anthracycline

Keywords in English

Daunodouble; clinical trial; Acute myeloid leukemia; cytarabine; anthracycline

Abstract

ORIG CZ

V originále

Double induction using two subsequent 7+3 regimens of cytarabine plus anthracycline is commonly performed in AML patients with an adequate performance status in order to maximize dose intensity upfront. However, for patients with a good early response at day 15 of first induction, there is no prospective randomized evidence on the necessity or value of a second induction cycle. In order to answer the question if good responders of the first 7+3 induction could be spared a second induction cycle, we set up randomized-controlled SAL DaunoDouble trial. The study prospectively assesses the outcome of patients with a good early response with respect to the number of induction cycles (single versus double). We assumed non-inferiority of single induction in terms of complete remission (CR/CRi) rate, based on a margin of 7.5%. Here, we present the results of the planned interim analysis.

In Czech

Dvojitá indukce pomocí dvou po sobě jdoucích 7+3 režimů cytarabinu plus antracyklinu se běžně provádí u pacientů s AML s adekvátním výkonnostním stavem, aby se předem maximalizovala intenzita dávky. U pacientů s dobrou časnou odpovědí 15. den první indukce však neexistuje žádný prospektivní randomizovaný důkaz o nutnosti nebo hodnotě druhého indukčního cyklu. Abychom odpověděli na otázku, zda by dobří respondenti prvních 7+3 indukce mohli být ušetřeni druhého indukčního cyklu, vytvořili jsme randomizovaně kontrolovanou studii SAL DaunoDouble. Studie prospektivně hodnotí výsledky pacientů s dobrou časnou odpovědí s ohledem na počet indukčních cyklů (jednoduchý versus dvojitý). Předpokládali jsme noninferioritu jednorázové indukce z hlediska míry kompletní remise (CR/CRi) na základě rozpětí 7,5 %. Zde uvádíme výsledky plánované interim analýzy.

Links

LM2018128, research and development project

Name: Český národní uzel Evropské sítě infrastruktur klinického výzkumu (Acronym: CZECRIN)

Investor: Ministry of Education, Youth and Sports of the CR

Citovat

ROLLIG, C., B. STEFFEN, N. ALAKEL, R. HERBST, R. NOPPENEY, M. HANOUN, Z. RACIL, K. SCHAFER-ECKART, A. KRAMER, A. NEUBAUER, C. D. BALDUS, C. SCHLIEMANN, M. KAUFMANN, J. MERTOVA, E. JOST, D. NIEMANN, J. NOVAK, S. W. KRAUSE, S. SCHOLL, G. HELD, S. B. PARMENTIER, T. SZOTKOWSKI, P. ZAK, A. RANK, M. WASS, S. BUSKE, M. KRAMER, F. FIEBIG, A. HAAKE, J. SCHETELIG, U. PLATZBECKER, C. THIEDE, C. MULLER-TIDOW, W. E. BERDEL, H. SERVE, G. EHNINGER, Jiří MAYER and M. BORNHAUSER. Remission and Survival after Single Versus Double Induction with 7+3 for Newly Diagnosed Acute Myeloid Leukemia: Results from the Planned Interim Analysis of Randomized Controlled SAL-Daunodouble Trial. 2020. Available from: https://dx.doi.org/10.1182/blood-2020-140246.

@proceedings{1807008,
   author = {Rollig, C. and Steffen, B. and Alakel, N. and Herbst, R. and Noppeney, R. and Hanoun, M. and Racil, Z. and SchaferandEckart, K. and Kramer, A. and Neubauer, A. and Baldus, C. D. and Schliemann, C. and Kaufmann, M. and Mertova, J. and Jost, E. and Niemann, D. and Novak, J. and Krause, S. W. and Scholl, S. and Held, G. and Parmentier, S. B. and Szotkowski, T. and Zak, P. and Rank, A. and Wass, M. and Buske, S. and Kramer, M. and Fiebig, F. and Haake, A. and Schetelig, J. and Platzbecker, U. and Thiede, C. and MullerandTidow, C. and Berdel, W. E. and Serve, H. and Ehninger, G. and Mayer, Jiří and Bornhauser, M.},
   doi = {http://dx.doi.org/10.1182/blood-2020-140246},
   keywords = {Daunodouble; clinical trial; Acute myeloid leukemia; cytarabine; anthracycline},
   language = {eng},
   title = {Remission and Survival after Single Versus Double Induction with 7+3 for Newly Diagnosed Acute Myeloid Leukemia: Results from the Planned Interim Analysis of Randomized Controlled SAL-Daunodouble Trial},
   url = {https://ashpublications.org/blood/article/136/Supplement%201/1/470174/Remission-and-Survival-after-Single-Versus-Double},
   year = {2020}
}

TY  - CONF
ID  - 1807008
AU  - Rollig, C. - Steffen, B. - Alakel, N. - Herbst, R. - Noppeney, R. - Hanoun, M. - Racil, Z. - Schafer-Eckart, K. - Kramer, A. - Neubauer, A. - Baldus, C. D. - Schliemann, C. - Kaufmann, M. - Mertova, J. - Jost, E. - Niemann, D. - Novak, J. - Krause, S. W. - Scholl, S. - Held, G. - Parmentier, S. B. - Szotkowski, T. - Zak, P. - Rank, A. - Wass, M. - Buske, S. - Kramer, M. - Fiebig, F. - Haake, A. - Schetelig, J. - Platzbecker, U. - Thiede, C. - Muller-Tidow, C. - Berdel, W. E. - Serve, H. - Ehninger, G. - Mayer, Jiří - Bornhauser, M.
PY  - 2020
TI  - Remission and Survival after Single Versus Double Induction with 7+3 for Newly Diagnosed Acute Myeloid Leukemia: Results from the Planned Interim Analysis of Randomized Controlled SAL-Daunodouble Trial
KW  - Daunodouble
KW  - clinical trial
KW  - Acute myeloid leukemia
KW  - cytarabine
KW  - anthracycline
UR  - https://ashpublications.org/blood/article/136/Supplement%201/1/470174/Remission-and-Survival-after-Single-Versus-Double
N2  - Double induction using two subsequent 7+3 regimens of cytarabine plus anthracycline is commonly performed in AML patients with an adequate performance status in order to maximize dose intensity upfront. However, for patients with a good early response at day 15 of first induction, there is no prospective randomized evidence on the necessity or value of a second induction cycle. In order to answer the question if good responders of the first 7+3 induction could be spared a second induction cycle, we set up randomized-controlled SAL DaunoDouble trial. The study prospectively assesses the outcome of patients with a good early response with respect to the number of induction cycles (single versus double). We assumed non-inferiority of single induction in terms of complete remission (CR/CRi) rate, based on a margin of 7.5%. Here, we present the results of the planned interim analysis.
ER  -

ROLLIG, C., B. STEFFEN, N. ALAKEL, R. HERBST, R. NOPPENEY, M. HANOUN, Z. RACIL, K. SCHAFER-ECKART, A. KRAMER, A. NEUBAUER, C. D. BALDUS, C. SCHLIEMANN, M. KAUFMANN, J. MERTOVA, E. JOST, D. NIEMANN, J. NOVAK, S. W. KRAUSE, S. SCHOLL, G. HELD, S. B. PARMENTIER, T. SZOTKOWSKI, P. ZAK, A. RANK, M. WASS, S. BUSKE, M. KRAMER, F. FIEBIG, A. HAAKE, J. SCHETELIG, U. PLATZBECKER, C. THIEDE, C. MULLER-TIDOW, W. E. BERDEL, H. SERVE, G. EHNINGER, Jiří MAYER and M. BORNHAUSER. \textit{Remission and Survival after Single Versus Double Induction with 7+3 for Newly Diagnosed Acute Myeloid Leukemia: Results from the Planned Interim Analysis of Randomized Controlled SAL-Daunodouble Trial}. 2020. Available from: https://dx.doi.org/10.1182/blood-2020-140246.

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