SWOG clinical trial number
CTSU/C10603

Phase III Randomized Study of Induction Therapy Comprising Daunorubicin Hydrochloride and Cytarabine With or Without Midostaurin Followed by Consolidation Therapy Comprising High-Dose Cytarabine and Midostaurin Followed by Continuation Therapy Comprising Midostaurin Alone in Patients With Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia

Closed
Published
Abbreviated Title
Phase III Flt3+ AML Daunorubicin+AraC +/- Midostaurin Induction, AraC/Midostaurin Consolidation, Midostaurin Continuation
Activated
02/01/2009
Closed
10/15/2011
Participants
CTSU

Research committees

Leukemia

Eligibility Criteria Expand/Collapse

The Southwest Oncology Group has endorsed this study through the Cancer Trials Support Unit (CTSU) of the National Cancer Institute.

Please contact the CTSU directly by phone (888/823-5923) or on the CTSU website (http://www.ctsu.org/) for more information and registration procedures.

Publication Information Expand/Collapse

2021

Midostaurin reduces the cumulative incidence of relapse and is tolerable for maintenance in FLT3-mutant acute myeloid leukemia (CALGB 10603)

RA Larson;S Mandrekar;L Huebner;B Sanford;C Laumann;S Geyer;C Bloomfield;C Thiede;T Prior;K Dohner;G Marcucci;M Voso;R Klisovic;I Galinsky;A Wei;J Sierra;M Sanz;J Brandwein;T de Witte;D Niederwieser;F Appelbaum;B Medeiros;M Tallman;J Krauter;R Schlenk;R Ganser;H Serve;G Ehninger;S Amadori;I Gathmann;H Dohner;R Stone Blood Mar 2. doi: 10.1038/s41375-021-01179-4. Online ahead of print, 2021

PMid: PMID33654204

2019

Genetic Landscape of FLT3-Mutated Acute Myeloid Leukemia (AML) Patients Treated within the RATIFY Trial (ALLIANCE C10603)

N Jahn;E Panina;L Bullinger;A Dolnik;J Herzig;T Blatte;A Benner;J Krzykalla;I Gathmann;RA Larson;F Lo-Coco;S Amadori;T Pryor;J Brandwein;F Appelbaum;B Medeiros;M Tallman;E Tiecke;C Pallaud;G Ehninger;M Heuser;A Ganser;RM Stone;C Thiede;H Dohner;C Bloomfield;K Dohner HemaSphere June; Vol 3, Suppl 1, p 436 (European Hematology Assn Congress, June 13-16, 2019 Amsterdam)

2018

Prognostic impact of insertion site in acute myeloid leukemia with FLT3 internal tandem duplication: results from the RATIFY study (Alliance)

F Rucker;L Du;T Blatte;J Krzykalla;I Gathmann;RA Larson;F Lo-Coco;S Amadori;T Prior;J Brandwein;F Appelbaum;B Medeiros;M Tallman;J Sierra;E Tiecke;C Pallaud;M Sanz;T de Witte;D Niederwieser;G Ehninger;M Heuser;M Ganser;L Bullinger;C Bloomfield;RM Stone;H Dohner;C Thiede;K Dohner Blood 132:435; American Society of Hematology Annual Meeting (Dec 1-4, 2018, San Diego, CA)

Comprehensive molecular profiling of FLT3-mutated acute myeloid leukemia (AML) patients treated within the RATIFY trial

N Jahn;N Panina;L Bullinger;A Dolnick;J Herzig;T Blatte;A Benner;J Krzykalla;I Gathmann;RA Larson;F Lo-Coco;S Amadori;T Prior;J Brandwein;F Appelbaum;B Medeiros;M Tallman;E Tiecke;C Pallaud;G Ehninger;M Heuser;A Ganser;RM Stone;C Thiede;H Dohner;C Bloomfield;K Dohner Blood 132:1534; American Society of Hematology Annual Meeting (Dec 1-4, 2018, San Diego, CA), poster

RATIFY: Prognostic Impact of FLT3 Tyrosine Kinase Domain (TKD) and NPM1 Mutation Status in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Treated with Midostaurin or Placebo Plus Standard Chemotherapy

M Voso;RA Larson;T Prior;G Marcucci;D Jones;J Krauter;M Heuser;S Lavorgna;J Nomdedeu;K Laumann;S Geyer;R Klisovic;A Wei;J Sierra;M Sanz;J Brandwein;T de Witte;JH Jansen;D Niederwieser;F Appelbaum;B Medeiros;M Tallman;R Schlenk;A Ganser;H Serve;G Ehninger;S Amadori;Y Cheng;I Gathmann;E Tiecke;C Thiede;K Dohner;H Dohner;RM Stone;C Bloomfield;F Lo-Coco Blood 132:2668; American Society of Hematology Annual Meeting (Dec 1-4, 2018, San Diego, CA), poster

2017

An Analysis of Maintenance Therapy and Post-Midostaurin Outcomes in the International Prospective Randomized, Placebo-Controlled, Double-Blind Trial (CALGB 10603/RATIFY [Alliance]) for Newly Diagnosed Acute Myeloid Leukemia (AML) Patients with FLT3 Mutations

RA Larson;S Mandrekar;B Sanford;K Laumann;S Geyer;C Bloomfield;C Thiede;T Prior;K Dohner;G Marcucci;F Lo-Coco;B Klisovic;A Wei;J Sierra;M Sanz;J Brandwein;T de Witte;D Niederwieser;F Appelbaum;B Medeiros;M Tallman;J Krauter;RF Schlenk;A Ganser;H Serve;G Ehninger;S Amadori;H Dohner;R Stone Blood 130:145; American Society of Hematology Annual Meeting (December 9-12, 2017, Atlanta, GA), oral

An Analysis of the Cumulative Incidence of Relapse (CIR) in the International Prospective Randomized, Placebo-Controlled, Double-Blind Trial (CALGB 10603 / RATIFY [Alliance]) for Newly Diagnosed Acute Myeloid Leukemia (AML) Patients with FLT3 Mutations

R Stone;S Mandrekar;B Sanford;K Laumann;S Geyer;C Bloomfield;K Dohner;C Thiede;G Marcucci;F Lo-Coco;R Klisovic;A Wei;J Sierra;M Sanz;J Brandwein;T de Witte;D Niederwieser;F Appelbaum;B Medeiros;MS Tallman;J Kraute;R Schlenk;A Ganser;H Serve;G Ehninger;S Amadori;H Dohner;R Larson Blood 130:2580; American Society of Hematology Annual Meeting (December 9-12, 2017, Atlanta, GA), poster

Prognostic impact of NPM1/FLT3-ITD genotypes from randomized patients treated within the RATIFY CALGB 10603 (Alliance) Study

K Dohner;S Mandrekar;C Thiede;R Larson;T Prior;G Marcucci;J Krauter;M Heuser;F Lo-Coco;JF Nomdedeu;B Sanford;K Laumann;S Geyer;R Klisovic;A Wei;J Sierra;M Sanz;J Brandwein;T de Witte;D Niederwieser;F Appelbaum;B Medeiros;M Tallman;R Schlenk;A Ganser;H Serve;G Ehninger;S Amadori;Y Cheng;C Pallaud;R Stone;H Dohner;C Bloomfield Blood 130:467; American Society of Hematology Annual Meeting (December 9-12, 2017, Atlanta, GA), oral presentation

Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 mutation

RM Stone;SJ Mandrekar;BL Sanford;K Laumann;S Geyer;C Bloomfield;C Thiede;T Prior;K Dohner;G Marcucci;F Lo-Coco;RB Klisovic;A Wei;J Sierra;M Sanz;JM Brandwein;T de Witte;D Niederwieser;F Appelbaum;B Medeiros;MS Tallman;J Krauter;R Schlenk;A Ganser;H Serve;G Ehninger;S Amadori;RA Larson;H Dohner New England Journal of Medicine Aug 3;377(5):454-464

PMid: PMID28644114 | PMC number: PMC5754190

2015

The multi-kinase inhibitor midostaurin (M) prolongs survival compared with placebo (P) in combination with daunorubicin (D)/cytarabine (C) induction (ind), high-dose C consolidation (consol), and as maintenance (maint) therapy in newly diagnosed acute myeloid leukemia (AML) patients (pts) age 18-60 with FLT3 mutations (muts): an international prospective randomized (rand) P-controlled double-blind trial (CALGB 10603/RATIFY [Alliance])

M Stone;S Mandrekar;BL Sanford;S Geyer;C Bloomfield;K Dohner;C Thiede;G Marcucci;F Lo-Coco;R Klisovic;A Wei;J Sierra;M Sanz;J Brandwein;T de Witte;D Niederwieser;F Appelbaum;M Tallman;B Medeiros;J Krauter;F Schlenk;A Ganser;H Serve;G Ehninger;S Amadori;RA Larson;H Dohner Blood 126(23):6;American Society of Hematology Annual Meeting (Dec 5-8, 2015, Orlando, FL), oral;