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1. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Erba, Harry P, Montesinos, Pau, Kim, Hee-Je, Patkowska, Elżbieta, Vrhovac, Radovan, Žák, Pavel, Wang, Po-Nan, Mitov, Tsvetomir, Hanyok, James, Kamel, Yasser Mostafa, Rohrbach, Jaime E Connolly, Liu, Li, Benzohra, Aziz, Lesegretain, Arnaud, Cortes, Jorge, Perl, Alexander E, Sekeres, Mikkael A, Dombret, Hervé, Amadori, Sergio, Wang, Jianxiang, Levis, Mark J, and Schlenk, Richard F

Published
2023
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2. AML-029 Quizartinib Prolonged Overall Survival (OS) vs Placebo Plus Intensive Induction and Consolidation Therapy Followed by Single-Agent Continuation in Patients Aged 18-75 Years With Newly Diagnosed FLT3–Internal Tandem Duplication Positive (FLT3-ITD+) Acute Myeloid Leukemia (AML)

Author

Erba, Harry, Montesinos, Pau, Vrhovac, Radovan, Patkowska, Elzbieta, Kim, Hee-Je, Zak, Pavel, Wang, Po-Nan, Mitov, Tsvetomir, Hanyok, James, Liu, Li, Benzohra, Aziz, Lesegretain, Arnaud, Cortes, Jorge, Perl, Alexander, Sekeres, Mikkael, Dombret, Hervé, Amadori, Sergio, Wang, Jianxiang, Levis, Mark, and Schlenk, Richard

Published
2022
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3. Oral Abstract: CT-186 Impact of Allogeneic Hematopoietic Cell Transplantation (allo-HCT) in First Complete Remission (CR1) in Addition to FLT3 Inhibition with Quizartinib in Acute Myeloid Leukemia (AML) with FLT3–Internal Tandem Duplication (FLT3-ITD): Results from the QuANTUM-First Trial

Author

Schlenk, Richard F., primary, Montesinos, Pau, additional, Romero-Aguilar, Antonio, additional, Vrhovac, Radovan, additional, Patkowska, Elżbieta, additional, Kim, Hee-Je, additional, Zak, Pavel, additional, Wang, Po-Nan, additional, Hanyok, James, additional, Liu, Li, additional, Kamel, Yasser Mostafa, additional, Lesegretain, Arnaud, additional, Cortes, Jorge, additional, Sekeres, Mikkael A., additional, Dombret, Hervé, additional, Amadori, Sergio, additional, Wang, Jianxiang, additional, Perl, Alexander E., additional, Levis, Mark J., additional, and Erba, Harry P., additional

Published
2023
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4. CT-186 Impact of Allogeneic Hematopoietic Cell Transplantation (allo-HCT) in First Complete Remission (CR1) in Addition to FLT3 Inhibition With Quizartinib in Acute Myeloid Leukemia (AML) With FLT3–Internal Tandem Duplication (FLT3-ITD): Results from the QuANTUM-First Trial

Author

Schlenk, Richard F., primary, Montesinos, Pau, additional, Romero-Aguilar, Antonio, additional, Vrhovac, Radovan, additional, Patkowska, Elżbieta, additional, Kim, Hee-Je, additional, Zak, Pavel, additional, Wang, Po-Nan, additional, Hanyok, James, additional, Liu, Li, additional, Kamel, Yasser Mostafa, additional, Lesegretain, Arnaud, additional, Cortes, Jorge, additional, Sekeres, Mikkael A., additional, Dombret, Hervé, additional, Amadori, Sergio, additional, Wang, Jianxiang, additional, Perl, Alexander E., additional, Levis, Mark J., additional, and Erba, Harry P., additional

Published
2023
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5. AML-132 QuANTUM-First Trial: FLT3–Internal Tandem Duplication (FLT3-ITD)–Specific Measurable Residual Disease (MRD) Clearance Is Associated With Improved Overall Survival (OS)

Author

Levis, Mark J., primary, Erba, Harry P., additional, Montesinos, Pau, additional, Vrhovac, Radovan, additional, Patkowska, Elżbieta, additional, Kim, Hee-Je, additional, Zak, Pavel, additional, Wang, Po-Nan, additional, Rohrbach, Jaime E. Connolly, additional, Chang, Ken C.N., additional, Hanyok, James, additional, Liu, Li, additional, Kamel, Yasser Mostafa, additional, Lesegretain, Arnaud, additional, Cortes, Jorge, additional, Sekeres, Mikkael A., additional, Dombret, Hervé, additional, Amadori, Sergio, additional, Wang, Jianxiang, additional, Schlenk, Richard F., additional, and Perl, Alexander E., additional

Published
2023
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6. POSTER: AML-132 QuANTUM-First Trial: FLT3–Internal Tandem Duplication (FLT3-ITD)–Specific Measurable Residual Disease (MRD) Clearance Is Associated With Improved Overall Survival (OS)

Author

Levis, Mark J., primary, Erba, Harry P., additional, Montesinos, Pau, additional, Vrhovac, Radovan, additional, Patkowska, Elżbieta, additional, Kim, Hee-Je, additional, Zak, Pavel, additional, Wang, Po-Nan, additional, Rohrbach, Jaime E. Connolly, additional, Chang, Ken C.N., additional, Hanyok, James, additional, Liu, Li, additional, Kamel, Yasser Mostafa, additional, Lesegretain, Arnaud, additional, Cortes, Jorge, additional, Sekeres, Mikkael A., additional, Dombret, Hervé, additional, Amadori, Sergio, additional, Wang, Jianxiang, additional, Schlenk, Richard F., additional, and Perl, Alexander E., additional

Published
2023
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7. POSTER: CT-186 Impact of Allogeneic Hematopoietic Cell Transplantation (allo-HCT) in First Complete Remission (CR1) in Addition to FLT3 Inhibition With Quizartinib in Acute Myeloid Leukemia (AML) With FLT3–Internal Tandem Duplication (FLT3-ITD): Results from the QuANTUM-First Trial

Author

Schlenk, Richard F., primary, Montesinos, Pau, additional, Romero-Aguilar, Antonio, additional, Vrhovac, Radovan, additional, Patkowska, Elżbieta, additional, Kim, Hee-Je, additional, Zak, Pavel, additional, Wang, Po-Nan, additional, Hanyok, James, additional, Liu, Li, additional, Kamel, Yasser Mostafa, additional, Lesegretain, Arnaud, additional, Cortes, Jorge, additional, Sekeres, Mikkael A., additional, Dombret, Hervé, additional, Amadori, Sergio, additional, Wang, Jianxiang, additional, Perl, Alexander E., additional, Levis, Mark J., additional, and Erba, Harry P., additional

Published
2023
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8. P483: QUANTUM-FIRST TRIAL: FLT3-ITD–SPECIFIC MEASURABLE RESIDUAL DISEASE (MRD) CLEARANCE IS ASSOCIATED WITH IMPROVED OVERALL SURVIVAL

Author

Levis, Mark J, primary, Erba, Harry P., additional, Montesinos, Pau, additional, Vrhovac, Radovan, additional, Patkowska, Elżbieta, additional, Kim, Hee-Je, additional, Zak, Pavel, additional, Wang, Po-Nan, additional, Connolly Rohrbach, Jaime E., additional, Chang, Ken C.N., additional, Hanyok, James, additional, Liu, LI, additional, Mostafa Kamel, Yasser, additional, Lesegretain, Arnaud, additional, Cortes, Jorge, additional, Sekeres, Mikkael A., additional, Dombret, Hervé, additional, Amadori, Sergio, additional, Wang, Jianxiang, additional, Schlenk, Richard F., additional, and Perl, Alexander E., additional

Published
2023
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9. S137: IMPACT OF ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION IN FIRST COMPLETE REMISSION PLUS FLT3 INHIBITION WITH QUIZARTINIB IN ACUTE MYELOID LEUKEMIA WITH FLT3-ITD: RESULTS FROM QUANTUM-FIRST

Author

Schlenk, Richard, primary, Montesinos, Pau, additional, Romero-Aguilar, Antonio, additional, Vrhovac, Radovan, additional, Patkowska, Elżbieta, additional, Kim, Hee-Je, additional, Zak, Pavel, additional, Wang, Po-Nan, additional, Hanyok, James, additional, Liu, LI, additional, Kamel, Yasser Mostafa, additional, Benzohra, Aziz, additional, Lesegretain, Arnaud, additional, Cortes, Jorge, additional, Sekeres, Mikkael A., additional, Dombret, Hervé, additional, Amadori, Sergio, additional, Wang, Jianxiang, additional, Perl, Alexander E., additional, Levis, Mark J., additional, and Erba, Harry P., additional

Published
2023
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11. Impact of Allogeneic Hematopoietic Cell Transplantation in First Complete Remission in Addition to FLT3 Inhibition with Quizartinib in Acute Myeloid Leukemia with FLT3-Internal Tandem Duplication: Results from the Quantum-First Trial

Author

Schlenk, Richard F., primary, Montesinos, Pau, additional, Romero-Aguilar, Antonio, additional, Vrhovac, Radovan, additional, Patkowska, Elżbieta, additional, Kim, Hee-Je, additional, Zak, Pavel, additional, Wang, Po-Nan, additional, Hanyok, James, additional, Liu, Li, additional, Kamel, Yasser Mostafa, additional, Benzohra, Aziz, additional, Lesegretain, Arnaud, additional, Cortes, Jorge E., additional, Sekeres, Mikkael A., additional, Dombret, Hervé, additional, Amadori, Sergio, additional, Wang, Jianxiang, additional, Perl, Alexander E., additional, Levis, Mark J., additional, and Erba, Harry P., additional

Published
2022
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12. Quantum-First Trial: FLT3-ITD-Specific MRD Clearance Is Associated with Improved Overall Survival

Author

Levis, Mark J., primary, Erba, Harry P., additional, Montesinos, Pau, additional, Vrhovac, Radovan, additional, Patkowska, Elzbieta, additional, Kim, Heeje, additional, Zak, Pavel, additional, Wang, Po-Nan, additional, Rohrbach, Jaime E. Connolly, additional, Chang, Ken CN, additional, Hanyok, James, additional, Liu, Li, additional, Kamel, Yasser Mostafa, additional, Lesegretain, Arnaud, additional, Cortes, Jorge E., additional, Sekeres, Mikkael A., additional, Dombret, Hervé, additional, Amadori, Sergio, additional, Wang, Jianxiang, additional, Schlenk, Richard F., additional, and Perl, Alexander, additional

Published
2022
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13. Poster: AML-029 Quizartinib Prolonged Overall Survival (OS) vs Placebo Plus Intensive Induction and Consolidation Therapy Followed by Single-Agent Continuation in Patients Aged 18-75 Years With Newly Diagnosed FLT3–Internal Tandem Duplication Positive (FLT3-ITD+) Acute Myeloid Leukemia (AML)

Author

Erba, Harry, primary, Montesinos, Pau, additional, Vrhovac, Radovan, additional, Patkowska, Elzbieta, additional, Kim, Hee-Je, additional, Zak, Pavel, additional, Wang, Po-Nan, additional, Mitov, Tsvetomir, additional, Hanyok, James, additional, Liu, Li, additional, Benzohra, Aziz, additional, Lesegretain, Arnaud, additional, Cortes, Jorge, additional, Perl, Alexander, additional, Sekeres, Mikkael, additional, Dombret, Hervé, additional, Amadori, Sergio, additional, Wang, Jianxiang, additional, Levis, Mark, additional, and Schlenk, Richard, additional

Published
2022
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14. Edoxaban versus Warfarin in Patients with Atrial Fibrillation

Author

Giugliano, Robert P., Ruff, Christian T., Braunwald, Eugene, Murphy, Sabina A., Wiviott, Stephen D., Halperin, Jonathan L., Waldo, Albert L., Ezekowitz, Michael D., Weitz, Jeffrey I., Špinar, Jindřich, Ruzyllo, Witold, Ruda, Mikhail, Koretsune, Yukihiro, Betcher, Joshua, Shi, Minggao, Grip, Laura T., Patel, Shirali P., Patel, Indravadan, Hanyok, James J., Mercuri, Michele, and Antman, Elliott M.

Published
2013
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18. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: Design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48)

Author

Ruff, Christian T., Giugliano, Robert P., Antman, Elliott M., Crugnale, Sharon E., Bocanegra, Tomas, Mercuri, Michele, Hanyok, James, Patel, Indravadan, Shi, Minggao, Salazar, Dan, McCabe, Carolyn H., and Braunwald, Eugene

Published
2010

19. Clinical pharmacokinetics of sotalol

Author

Hanyok, James J.

Subjects
Anti-arrhythmia drugs -- Physiological aspects, Ventricular fibrillation -- Drug therapy, Drug interactions -- Physiological aspects, Health
Abstract

Sotalol is an antiarrhythmic agent with combined class II and III properties. It is nearly completely absorbed after oral administration and undergoes essentially no first-pass hepatic metabolism. As a result, its absolute bioavailability is 90-100%. Peak plasma concentrations are reached 2-4 hours after an oral dose. Administering sotalol with food reduces its bioavailability by approximately 20%. A 2-compartment model adequately describes the decline of sotalol plasma concentrations after intravenous or oral administration. The drug has an apparent volume of distribution of 1.2-2.4 liters/kg. Results of animal studies indicate that sotalol distributes into a number of tissues, including those of the heart, liver, and kidney, but it is hydrophilic and thus penetrates the central nervous system poorly. Sotagol does not bind to plasma proteins. No significant biotransformation of sotalol takes place in humans. Sotalol is primarily eliminated by renal excretion, with approximately 80-90% of a dose being excreted unchanged in the urine; a small amount is excreted unchanged in the feces. In subjects with normal renal function, total body clearance of sotalol averages 150 mL/min and the terminal elimination half-life is 10-20 hours. Long-term administration of sotalol does not alter its kinetics, and plasma concentrations following single or multiple doses are proportional to the dose. Sotalol is a racemic mixture of the d-and I-stereoisomers. d,I-Sotalol is excreted in the urine equally as d-and I-sotalol, and there is no evidence of racemization. The clearance of sotalol is reduced and its elimination half-life is prolonged in patients with renal insufficiency; as a result, dosage adjustment is necessary. The elderly exhibit a modest reduction in sotalol clearance that is related to their diminished renal function. There have been no reports of clinically significant pharmacokinetic drug interactions involving sotalol, but pharmacologic interactions may occur. The pharmacologic effects of sotalol are related to its plasma concentrations. Significant [beta] blockade occurs at concentrations [is greater than or equal to] 800 ng/mL, and class III activity has been demonstrated at concentrations as low as 1,200 ng/mL. (AM J Cardiol 1993;72:19A-26A)

Published
1993

20. Phase 3 (P3) study of quizartinib (Q) or placebo (P) with induction (IND) and consolidation chemotherapy (CON) and as maintenance (MN) in patients (pts) with newly diagnosed (NDx) FLT3-ITD–positive acute myeloid leukemia (AML): the QuANTUM-First study.

Author

Erba, Harry Paul, primary, Levis, Mark J., additional, Sekeres, Mikkael A., additional, Dombret, Herve, additional, Amadori, Sergio, additional, Zernovak, Oleg, additional, Mires, Derek Edward, additional, Ge, NanXiang, additional, Hanyok, James, additional, Macintyre, Susan, additional, Gokmen, Sugun, additional, Gammon, Guy, additional, and Schlenk, Richard F, additional

Published
2016
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22. Edoxaban versus warfarin in patients with atrial fibrillation

Author

Giugliano, Robert P, Ruff, Christian T, Braunwald, Eugene, Murphy, Sabina A, Wiviott, Stephen D, Halperin, Jonathan L, Waldo, Albert L, Ezekowitz, Michael D, Weitz, Jeffrey I, Špinar, Jindřich, Ruzyllo, Witold, Ruda, Mikhail, Koretsune, Yukihiro, Betcher, Joshua, Shi, Minggao, Grip, Laura T, Patel, Shirali P, Patel, Indravadan, Hanyok, James J, Mercuri, Michele, Antman, Elliott M, Iversen, Helle Klingenberg, Giugliano, Robert P, Ruff, Christian T, Braunwald, Eugene, Murphy, Sabina A, Wiviott, Stephen D, Halperin, Jonathan L, Waldo, Albert L, Ezekowitz, Michael D, Weitz, Jeffrey I, Špinar, Jindřich, Ruzyllo, Witold, Ruda, Mikhail, Koretsune, Yukihiro, Betcher, Joshua, Shi, Minggao, Grip, Laura T, Patel, Shirali P, Patel, Indravadan, Hanyok, James J, Mercuri, Michele, Antman, Elliott M, and Iversen, Helle Klingenberg

Abstract

BACKGROUND: Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known.METHODS: We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding.RESULTS: The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P<0.001 for noninferiority) and 1.61% with low-dose edoxaban (hazard ratio, 1.07; 97.5% CI, 0.87 to 1.31; P=0.005 for noninferiority). In the intention-to-treat analysis, there was a trend favoring high-dose edoxaban versus warfarin (hazard ratio, 0.87; 97.5% CI, 0.73 to 1.04; P=0.08) and an unfavorable trend with low-dose edoxaban versus warfarin (hazard ratio, 1.13; 97.5% CI, 0.96 to 1.34; P=0.10). The annualized rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban (hazard ratio, 0.80; 95% CI, 0.71 to 0.91; P<0.001) and 1.61% with low-dose edoxaban (hazard ratio, 0.47; 95% CI, 0.41 to 0.55; P<0.001). The corresponding annualized rates of death from cardiovascular causes were 3.17% versus 2.74% (hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), and 2.71% (hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P=0.008), and the corresponding rates of the key secondary end point (a composite of stroke, systemic embolism, or death from cardiovascular causes) were 4.43% versus 3.85% (hazard ratio, 0.87; 95% CI, 0.78 to 0.96; P=0.005), an

Published
2013

23. Vasopeptidase inhibition with omapatrilat in chronic heart failure: acute and long-term hemodynamic and neurohumoral effects

Author

McClean, Dougal R, primary, Ikram, Hamid, additional, Mehta, Sukh, additional, Heywood, J.Thomas, additional, Rousseau, Michel F, additional, Niederman, Alan L, additional, Sequeira, Rafael F, additional, Fleck, Eckart, additional, Singh, Steven N, additional, Coutu, Benoit, additional, Hanrath, Peter, additional, Komajda, Michel, additional, Bryson, Catherine C, additional, Qian, Chunlin, additional, and Hanyok, James J, additional

Published
2002
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28. An Evaluation of the Pharmacokinetics, Pharmacodynamics, and Dialyzability of Verapamil in Chronic Hemodialysis Patients.

Author

Hanyok, James J., Chow, Moses S.S., Kluger, Jeffrey, and Izard, Mark W.

Abstract

The pharmacokinetics and pharmacodynamics of verapamil were investigated in six chronic hemodialysis patients. A single oral 120-mg dose was administered both on a non-hemodialysis day and a hemodialysis day separated by ≥ 7 days. Blood pressure and PR interval were measured simultaneously with each blood sample. Plasma verapamil and norverapamil concentrations were analyzed by high pressure liquid chromatography. The mean Cmax, tmax, AUC, apparent plasma clearance, and terminal t1/2 were 190 ± 108 ng/mL, 0.6 ± 0.2 hour, 676 ± 443 ng ṁ hr/mL, 3926 ± 1933 mL/min, and 11.4 ± 4.0 hr, respectively, on the nonhemodialysis day. The dialysis clearance of verapamil and norverapamil was negligible. The t1/2 during hemodialysis was 3.6 ± 1.1 hr, compared with 3.4 ± 0.7 hr during the same period of time postdose on the nonhemodialysis day (NS, P > .05). Systolic and diastolic blood pressure decreased for up to 4 hours postdose, whereas the PR interval tended to increase. Conclusions include: (1) the single oral-dose pharmacokinetics and pharmacodynamics of verapamil in chronic hemodialysis patients are similar to published data in normal subjects and cardiac patients and (2) verapamil and norverapamil are not significantly removed by hemodialysis, so that supplemental doses are not necessary. [ABSTRACT FROM AUTHOR]

Published
1988
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29. Lorcainide for the Treatment of Refractory Ventricular Tachycardia: Clinical and Electrophysiologic Results.

Author

Hanyok, James J., Kluger, Jeffrey, Chow, Moses S. S., and Fieldman, Arnold

Abstract

The electrophysiologic effects and antiarrhythmic efficacy of lorcainide were evaluated using programmed electrical stimulation (PES) in 14 patients with ventricular tachycardia (VT) refractory to conventional drug therapy. Lorcainide was administered orally (200-400 mg/d, eight patients), intravenously (150 mg/d, one patient), or by both routes (250-380 mg/d, five patients) prior to PES. In 13 patients undergoing both control and lorcainide PES, lorcainide increased the QRS duration (102 ± 28 to 125 ± 28 ms, P < .001) and the QTc interval (430 ± 39 to 471 ± 32 ms, P < .01) but had no effect on the RR interval (786 ± 156 to 780 ± 172 ms, P > .2). The right ventricular effective refractory period increased from 258 ± 8 to 285 ± 22 ms (P < .001). Lorcainide prevented VT induction or resulted in induction of only well-tolerated, nonsustained VT in six of 14 patients (43%). The cycle length of induced VT increased from 264 ± 32 to 306 ± 34 ms (P < .01). Of six patients started on chronic therapy, four still receive lorcainide after 18 ±7 months. Adverse effects have consisted mainly of sleep disturbances. Thus, it can be stated that lorcainide is effective in certain patients with VT refractory to conventional therapy. [ABSTRACT FROM AUTHOR]

Published
1987
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