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Original Articles

A 2:1 randomized, open-label, phase II study of selinexor vs. physician’s choice in older patients with relapsed or refractory acute myeloid leukemia

Kendra Sweeta Moffitt Cancer Center, Tampa, FL, USACorrespondence[email protected]
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Bhavana Bhatnagarb Ohio State University, Columbus, OH, USAView further author information

Hartmut Döhnerc University of Ulm, Ulm, GermanyView further author information

Will Donnelland Sarah Cannon Cancer Center, Nashville, TN, USAView further author information

Olga Frankfurte Northwestern University, Chicago, IL, USAView further author information

Michael Heuserf Hannover Medical School, Hannover, GermanyView further author information

Vamsi Kotag Emory University, Atlanta, GA, USAView further author information

Hongtao Liuh University of Chicago, Chicago, IL, USAView further author information

Emmanuel Raffouxi Hôpital Saint-Louis, Paris, FranceView further author information

Gail J. Robozj Weill Cornell Medicine, New York, NY, USAView further author information

Christoph Rölligk Dresden University of Technology, Dresden, GermanyView further author information

Margaret M. Showell Johns Hopkins University, Baltimore, MD, USAView further author information

Stephen A. Strickland Jr.m Vanderbilt-Ingram Cancer Center, Nashville, TN, USAView further author information

Susana Vivesn ICO Badalona-Hospital Germans Trias i Pujol, Badalona, SpainView further author information

Shijie Tango Karyopharm Therapeutics, Newton, MA, USAView further author information

Thaddeus J. Ungero Karyopharm Therapeutics, Newton, MA, USAView further author information

Anita Joshio Karyopharm Therapeutics, Newton, MA, USAView further author information

Yao Shenp DarwinHealth Inc, New York, NY, USAView further author information

Mariano J. Alvarezp DarwinHealth Inc, New York, NY, USA;q Columbia University, New York, NY, USAView further author information

Andrea Califanoq Columbia University, New York, NY, USAView further author information

Marsha Crochiereo Karyopharm Therapeutics, Newton, MA, USAView further author information

Yosef Landesmano Karyopharm Therapeutics, Newton, MA, USAView further author information

Michael Kauffmano Karyopharm Therapeutics, Newton, MA, USAView further author information

Jatin Shaho Karyopharm Therapeutics, Newton, MA, USAView further author information

Sharon Shachamo Karyopharm Therapeutics, Newton, MA, USAView further author information

Michael R. Savonar Vanderbilt University, Nashville, TN, USAView further author information

Pau Montesinoss Departamento de Hematologia, Hospital Universitario y Politécnico La Fe, Valencia, Spain;t CIBERONC, Instituto de Salud Carlos III, Madrid, Spain

https://orcid.org/0000-0002-3275-5593 View further author information

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Figures & data

Table 1. Baseline demographics in the intent-to-treat population.

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Figure 1. Overall survival in the intent-to-treat population.

Table 2. Secondary efficacy variables in the intent-to-treat population.

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Figure 2. Overall survival in patients with and without CR plus CRi/CRp in the intent-to-treat population. mCRR = CR + CRi + CRp. CR: complete remission; CRi: complete remission with incomplete recovery; CRp: complete remission with incomplete platelet recovery; mCRR: modified complete remission rate; PC: treatment of physician’s choice.

Table 3. Summary of TEAEs occurring in the safety population.

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Table 4. Most common TEAEs occurring in ≥10% of patients in any treatment group in the safety population.

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Supplemental material

ilal_a_1950706_sm2478.docx

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Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and/or its supplementary material.

A 2:1 randomized, open-label, phase II study of selinexor vs. physician’s choice in older patients with relapsed or refractory acute myeloid leukemia

Table 1. Baseline demographics in the intent-to-treat population.

Table 2. Secondary efficacy variables in the intent-to-treat population.

Table 3. Summary of TEAEs occurring in the safety population.

Table 4. Most common TEAEs occurring in ≥10% of patients in any treatment group in the safety population.

ilal_a_1950706_sm2478.docx

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A 2:1 randomized, open-label, phase II study of selinexor vs. physician’s choice in older patients with relapsed or refractory acute myeloid leukemia

Figures & data

Table 1. Baseline demographics in the intent-to-treat population.

Table 2. Secondary efficacy variables in the intent-to-treat population.

Table 3. Summary of TEAEs occurring in the safety population.

Table 4. Most common TEAEs occurring in ≥10% of patients in any treatment group in the safety population.

ilal_a_1950706_sm2478.docx

Data availability statement

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