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708 results on '"Mandrekar, Sumithra J."'

1. Clinical evaluation of complete remission (CR) with partial hematologic recovery (CRh) in acute myeloid leukemia: a report of 7235 patients from seven cohorts

Author

Appelbaum, Jacob S., Wei, Andrew H., Mandrekar, Sumithra J., Tiong, Ing S., Chua, Chong Chyn, Teh, Tse-Chieh, Fong, Chun Yew, Ting, Stephen B., Weber, Daniela, Benner, Axel, Hill, Hannah, Saadati, Maral, Yin, Jun, Stone, Richard M., Garcia-Manero, Guillermo, Erba, Harry P., Uy, Geoffrey L., Marcucci, Guido, Larson, Richard A., Thomas, Abin, Freeman, Sylvie D., Almuina, Nuria Marquez, Döhner, Konstanze, Thomas, Ian, Russel, Nigel H., Döhner, Hartmut, Othus, Megan, Estey, Elihu H., and Walter, Roland B.

Published
2024
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2. Follow-up from the A041202 study shows continued efficacy of ibrutinib regimens for older adults with CLL

Author

Woyach, Jennifer A., Perez Burbano, Gabriela, Ruppert, Amy S., Miller, Cecelia, Heerema, Nyla A., Zhao, Weiqiang, Wall, Anna, Ding, Wei, Bartlett, Nancy L., Brander, Danielle M., Barr, Paul M., Rogers, Kerry A., Parikh, Sameer A., Stephens, Deborah M., Brown, Jennifer R., Lozanski, Gerard, Blachly, James, Nattam, Sreenivasa, Larson, Richard A., Erba, Harry, Litzow, Mark, Luger, Selina, Owen, Carolyn, Kuzma, Charles, Abramson, Jeremy S., Little, Richard F., Dinner, Shira, Stone, Richard M., Uy, Geoffrey, Stock, Wendy, Mandrekar, Sumithra J., and Byrd, John C.

Published
2024
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4. Geriatric assessment measures are predictive of outcomes in chronic lymphocytic leukemia

Author

Johnson, P. Connor, Woyach, Jennifer A., Ulrich, Angela, Marcotte, Veronique, Nipp, Ryan D., Lage, Daniel E., Nelson, Ashley M., Newcomb, Richard A., Rice, Julia, Lavoie, Mitchell W., Ritchie, Christine S., Bartlett, Nancy, Stephens, Deborah M., Ding, Wei, Owen, Carolyn, Stone, Richard, Ruppert, Amy S., Mandrekar, Sumithra J., Byrd, John C., El-Jawahri, Areej, Le-Rademacher, Jennifer, and Rosko, Ashley

Published
2023
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5. Feasibility of structuring electronic health record data to facilitate real‐world data research: ICAREdata methods applied to multicenter cancer clinical trials.

Author

George, Suzanne, Campbell, Nancy, Hillman, Shauna L., Harlos, Elizabeth S., Stein, David W. J., Chan, Miranda Y., Chow, Selina L., Elrahi, Cassandra L., Quina, Andre C., Kokolus, Maeve C., Casagni, Michelle D., Weiss, Matthias, Anderson, Daniel M., Stadler, Walter M., Hoff, Olivia C., Rivera, Donna R., Kluetz, Paul G., Mandrekar, Sumithra J., and Piantadosi, Steven

Subjects
ELECTRONIC health records, ELECTRONIC structure, CLINICAL trials, THERAPEUTICS, DATABASES
Abstract

Background: The use of electronic health record (EHR) data for research is limited by a lack of structure and a standard data model. The objective of the ICAREdata (Integrating Clinical Trials and Real‐World Endpoints Data) project was to structure key research data elements in EHRs using a minimal Common Oncology Data Elements (mCODE) data model to extract and transmit data. Methods: The ICAREdata project captured two EHR data elements essential to clinical trials: cancer disease status and treatment plan change. The project was implemented in clinical sites participating in Alliance for Clinical Trials in Oncology trials. Data were extracted from EHRs and sent by secure Fast Healthcare Interoperability Resource messaging (a standard for exchanging EHRs) to a database. Selected elements were compared with corresponding data from the trial's electronic data capture (EDC) system, Medidata Rave. Results: By December 2023, data were extracted and transmitted from 10 sites for 35 patients, involving 367 clinical encounters across 15 clinical trials. Data through March 2023 demonstrated that concordance for the elements treatment plan change and cancer disease status was 79% and 34%, respectively. When disease evaluation was reported by both EHR and EDC (n = 15), there was 87% agreement on cancer disease status. Conclusions: Documentation, extraction, and aggregation of structured data elements in EHRs using mCODE and ICAREdata methods is feasible in multi‐institutional cancer clinical trials. EDC as a reference data set allowed assessment of the completeness of EHR data capture. Future initiatives will focus on elements with shared definitions in clinical and research environments and efficient workflows. Plain Language Summary: Clinical trials use electronic case report forms to report data, and data must be manually entered on these forms, which is costly and time consuming.ICAREdata methods use structured, organized data from clinical trials that can be more easily shared instead having to enter free text into electronic health records. The direct use of data from electronic health records is limited by the lack of structure and a standard data model. The current work demonstrates that documentation, extraction, and aggregation of structured electronic health record data elements using mCODE and ICAREdata methods are technically feasible in multi‐institutional cancer clinical trials. [ABSTRACT FROM AUTHOR]

Published
2025
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6. Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience

Author

Zahrieh, David, Hillman, Shauna L., Tan, Angelina D., Frank, Jennifer L., Dockter, Travis, Meyers, Bobbi Jo, Cherevko, Cassie L., Peil, Elizabeth S., McCue, Shaylene, Kour, Oudom, Gunn, Heather J., Neuman, Heather B., Chang, George J., Paskett, Electra D., Mandrekar, Sumithra J., and Dueck, Amylou C.

Published
2022
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8. A Prospective Economic Analysis of Early Outcome Data From the Alliance A041202/ CCTG CLC.2 Randomized Phase III Trial Of Bendamustine-Rituximab Compared With Ibrutinib-Based Regimens in Untreated Older Patients With Chronic Lymphocytic Leukemia

Author

Cheung, Matthew C., Mittmann, Nicole, Owen, Carolyn, Abdel-Samad, Nizar, Fraser, Graeme A.M., Lam, Selay, Crump, Michael, Sperlich, Catherine, van der Jagt, Richard, Prica, Anca, Couban, Stephen, Woyach, Jennifer A., Ruppert, Amy S., Booth, Allison M., Mandrekar, Sumithra J., McDonald, Gail, Shepherd, Lois E., Yen, Hope, Chen, Bingshu E., and Hay, Annette E.

Published
2021
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11. Adverse event burden in older patients with CLL receiving bendamustine plus rituximab or ibrutinib regimens: Alliance A041202

Author

Ruppert, Amy S., Booth, Allison M., Ding, Wei, Bartlett, Nancy L., Brander, Danielle M., Coutre, Steven, Brown, Jennifer R., Nattam, Sreenivasa, Larson, Richard A., Erba, Harry, Litzow, Mark, Owen, Carolyn, Kuzma, Charles S., Abramson, Jeremy S., Little, Richard F., Smith, Scott E., Stone, Richard M., Byrd, John C., Mandrekar, Sumithra J., and Woyach, Jennifer A.

Published
2021
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12. Midostaurin reduces relapse in FLT3-mutant acute myeloid leukemia: the Alliance CALGB 10603/RATIFY trial

Author

Larson, Richard A., Mandrekar, Sumithra J., Huebner, Lucas J., Sanford, Ben L., Laumann, Kristina, Geyer, Susan, Bloomfield, Clara D., Thiede, Christian, Prior, Thomas W., Döhner, Konstanze, Marcucci, Guido, Voso, Maria Teresa, Klisovic, Rebecca B., Galinsky, Ilene, Wei, Andrew H., Sierra, Jorge, Sanz, Miguel A., Brandwein, Joseph M., de Witte, Theo, Niederwieser, Dietger, Appelbaum, Frederick R., Medeiros, Bruno C., Tallman, Martin S., Krauter, Jürgen, Schlenk, Richard F., Ganser, Arnold, Serve, Hubert, Ehninger, Gerhard, Amadori, Sergio, Gathmann, Insa, Döhner, Hartmut, and Stone, Richard M.

Published
2021
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20. Impact of NPM1/FLT3-ITD genotypes defined by the 2017 European LeukemiaNet in patients with acute myeloid leukemia

Author

Döhner, Konstanze, Thiede, Christian, Jahn, Nikolaus, Panina, Ekaterina, Gambietz, Agnes, Larson, Richard A., Prior, Thomas W., Marcucci, Guido, Jones, Dan, Krauter, Jürgen, Heuser, Michael, Voso, Maria Teresa, Ottone, Tiziana, Nomdedeu, Josep F., Mandrekar, Sumithra J., Klisovic, Rebecca B., Wei, Andrew H., Sierra, Jorge, Sanz, Miguel A., Brandwein, Joseph M., de Witte, Theo, Jansen, Joop H., Niederwieser, Dietger, Appelbaum, Frederick R., Medeiros, Bruno C., Tallman, Martin S., Schlenk, Richard F., Ganser, Arnold, Serve, Hubert, Ehninger, Gerhard, Amadori, Sergio, Gathmann, Insa, Benner, Axel, Pallaud, Celine, Stone, Richard M., Döhner, Hartmut, and Bloomfield, Clara D.

Published
2020
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21. A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study

Author

Schenk, Erin L., Mandrekar, Sumithra J., Dy, Grace K., Aubry, Marie Christine, Tan, Angelina D., Dakhil, Shaker R., Sachs, Bradley A., Nieva, Jorge J., Bertino, Erin, Lee Hann, Christine, Schild, Steven E., Wadsworth, Troy W., Adjei, Alex A., and Molina, Julian R.

Published
2020
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24. Improving attribution of adverse events in oncology clinical trials

Author

George, Goldy C., Barata, Pedro C., Campbell, Alicyn, Chen, Alice, Cortes, Jorge E., Hyman, David M., Jones, Lee, Karagiannis, Thomas, Klaar, Sigrid, Le-Rademacher, Jennifer G., LoRusso, Patricia, Mandrekar, Sumithra J., Merino, Diana M., Minasian, Lori M., Mitchell, Sandra A., Montez, Sandra, O'Connor, Daniel J., Pettit, Syril, Silk, Elaine, Sloan, Jeff A., Stewart, Mark, Takimoto, Chris H., Wong, Gilbert Y., Yap, Timothy A., Cleeland, Charles S., and Hong, David S.

Published
2019
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25. Impact of Imaging Frequency on Progression Free Survival in Alliance Trials Enrolling Patients with Follicular Lymphoma

Author

Rutherford, Sarah C., primary, Yin, Jun, additional, Pederson, Levi D., additional, Blum, Kristie A., additional, Martin, Peter, additional, Jung, Sin-Ho, additional, Grant, Barbara, additional, Rosenbaum, Cara A, additional, Cheson, Bruce David, additional, Bartlett, Nancy L., additional, Mandrekar, Sumithra J, additional, and Leonard, John P., additional

Published
2024
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28. Statistical Considerations and Software for Designing Sequential, Multiple Assignment, Randomized Trials (SMART) with a Survival Final Endpoint.

Author

Kravets, Sasha, Ruppert, Amy S., Jacobson, Sawyer B., Le-Rademacher, Jennifer G., and Mandrekar, Sumithra J.

Subjects
STATISTICAL software, SOFTWARE architecture, CHRONIC lymphocytic leukemia, DESIGN software, PROGRESSION-free survival
Abstract

Sequential, multiple assignment, randomized trial (SMART) designs are appropriate for comparing adaptive treatment interventions, in which intermediate outcomes (called tailoring variables) guide subsequent treatment decisions for individual patients. Within a SMART design, patients may be re-randomized to subsequent treatments following the outcomes of their intermediate assessments. In this paper, we provide an overview of statistical considerations necessary to design and implement a two-stage SMART design with a binary tailoring variable and a survival final endpoint. A chronic lymphocytic leukemia trial with a final endpoint of progression-free survival is used as an example for the simulations to assess how design parameters, including, choice of randomization ratios for each stage of randomization, and response rates of the tailoring variable affect the statistical power. We assess the choice of weights from restricted re-randomization on data analyses and appropriate hazard rate assumptions. Specifically, for a given first-stage therapy and prior to the tailoring variable assessment, we assume equal hazard rates for all patients randomized to a treatment arm. After the tailoring variable assessment, individual hazard rates are assumed for each intervention path. Simulation studies demonstrate that the response rate of the binary tailoring variable impacts power as it directly impacts the distribution of patients. We also confirm that when the first stage randomization is 1:1, it is not necessary to consider the first stage randomization ratio when applying the weights. We provide an R-shiny application for obtaining power for a given sample size for SMART designs. [ABSTRACT FROM AUTHOR]

Published
2024
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30. Randomized trial of 10 days of decitabine ± bortezomib in untreated older patients with AML: CALGB 11002 (Alliance)

Author

Roboz, Gail J., Mandrekar, Sumithra J., Desai, Pinkal, Laumann, Kristina, Walker, Alison R., Wang, Eunice S., Kolitz, Jonathan E., Powell, Bayard L., Attar, Eyal C., Stock, Wendy, Bloomfield, Clara D., Kohlschmidt, Jessica, Mrózek, Krzysztof, Hassane, Duane C., Garraway, Levi, Jané-Valbuena, Judit, Baltay, Michele, Tracy, Adam, Marcucci, Guido, Stone, Richard M., and Larson, Richard A.

Published
2018
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42. Population, Clinical, and Scientific Impact of National Cancer Institute's National Clinical Trials Network Treatment Studies

Author

Unger, Joseph M., primary, LeBlanc, Michael, additional, George, Suzanne, additional, Wolmark, Norman, additional, Curran, Walter J., additional, O'Dwyer, Peter J., additional, Schnall, Mitchell D., additional, Mannel, Robert S., additional, Mandrekar, Sumithra J., additional, Gray, Robert J., additional, Zhao, Fengmin, additional, Bah, Mariama, additional, Vaidya, Riha, additional, and Blanke, Charles D., additional

Published
2023
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43. Perspectives on This Article from Phase 0 Clinical Chemoprevention Trial of the Akt Inhibitor SR13668

Author

Reid, Joel M., primary, Walden, Chad A., primary, Qin, Rui, primary, Ziegler, Katie L. Allen, primary, Haslam, John L., primary, Rajewski, Roger A., primary, Warndahl, Roger, primary, Fitting, Cindy L., primary, Boring, Daniel, primary, Szabo, Eva, primary, Crowell, James, primary, Perloff, Marjorie, primary, Jong, Ling, primary, Bauer, Brent A., primary, Mandrekar, Sumithra J., primary, Ames, Matthew M., primary, and Limburg, Paul J., primary

Published
2023
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44. Data from Phase 0 Clinical Chemoprevention Trial of the Akt Inhibitor SR13668

Author

Reid, Joel M., primary, Walden, Chad A., primary, Qin, Rui, primary, Ziegler, Katie L. Allen, primary, Haslam, John L., primary, Rajewski, Roger A., primary, Warndahl, Roger, primary, Fitting, Cindy L., primary, Boring, Daniel, primary, Szabo, Eva, primary, Crowell, James, primary, Perloff, Marjorie, primary, Jong, Ling, primary, Bauer, Brent A., primary, Mandrekar, Sumithra J., primary, Ames, Matthew M., primary, and Limburg, Paul J., primary

Published
2023
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45. Data from A Randomized Phase IIb Trial of myo-Inositol in Smokers with Bronchial Dysplasia

Author

Lam, Stephen, primary, Mandrekar, Sumithra J., primary, Gesthalter, Yaron, primary, Allen Ziegler, Katie L., primary, Seisler, Drew K., primary, Midthun, David E., primary, Mao, Jenny T., primary, Aubry, Marie Christine, primary, McWilliams, Annette, primary, Sin, Don D., primary, Shaipanich, Tawimas, primary, Liu, Gang, primary, Johnson, Evan, primary, Bild, Andrea, primary, Lenburg, Marc E., primary, Ionescu, Diana N., primary, Mayo, John, primary, Yi, Joanne (Eunhee), primary, Tazelaar, Henry, primary, Harmsen, William S., primary, Smith, Judith, primary, Spira, Avrum E., primary, Beane, Jennifer, primary, Limburg, Paul J., primary, and Szabo, Eva, primary

Published
2023
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46. Supplementary Table 1 from A Randomized Phase IIb Trial of myo-Inositol in Smokers with Bronchial Dysplasia

Author

Lam, Stephen, primary, Mandrekar, Sumithra J., primary, Gesthalter, Yaron, primary, Allen Ziegler, Katie L., primary, Seisler, Drew K., primary, Midthun, David E., primary, Mao, Jenny T., primary, Aubry, Marie Christine, primary, McWilliams, Annette, primary, Sin, Don D., primary, Shaipanich, Tawimas, primary, Liu, Gang, primary, Johnson, Evan, primary, Bild, Andrea, primary, Lenburg, Marc E., primary, Ionescu, Diana N., primary, Mayo, John, primary, Yi, Joanne (Eunhee), primary, Tazelaar, Henry, primary, Harmsen, William S., primary, Smith, Judith, primary, Spira, Avrum E., primary, Beane, Jennifer, primary, Limburg, Paul J., primary, and Szabo, Eva, primary

Published
2023
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47. Supplementary Table 2 from A Randomized Phase IIb Trial of myo-Inositol in Smokers with Bronchial Dysplasia

Author

Lam, Stephen, primary, Mandrekar, Sumithra J., primary, Gesthalter, Yaron, primary, Allen Ziegler, Katie L., primary, Seisler, Drew K., primary, Midthun, David E., primary, Mao, Jenny T., primary, Aubry, Marie Christine, primary, McWilliams, Annette, primary, Sin, Don D., primary, Shaipanich, Tawimas, primary, Liu, Gang, primary, Johnson, Evan, primary, Bild, Andrea, primary, Lenburg, Marc E., primary, Ionescu, Diana N., primary, Mayo, John, primary, Yi, Joanne (Eunhee), primary, Tazelaar, Henry, primary, Harmsen, William S., primary, Smith, Judith, primary, Spira, Avrum E., primary, Beane, Jennifer, primary, Limburg, Paul J., primary, and Szabo, Eva, primary

Published
2023
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