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4. Treatment‐free remission after dasatinib in patients with chronic myeloid leukaemia in chronic phase with deep molecular response: Final 5‐year analysis of DASFREE

Author

Shah, Neil P, García‐Gutiérrez, Valentín, Jiménez‐Velasco, Antonio, Larson, Sarah M, Saussele, Susanne, Rea, Delphine, Mahon, François‐Xavier, Levy, Moshe Yair, Gómez‐Casares, María Teresa, Mauro, Michael J, Sy, Oumar, Martin‐Regueira, Patricia, and Lipton, Jeffrey H

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Research, Rare Diseases, 6.1 Pharmaceuticals, Cancer, Humans, Dasatinib, Protein Kinase Inhibitors, Treatment Outcome, Neoplasm Recurrence, Local, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, chronic phase chronic myeloid leukaemia, dasatinib, deep molecular response, major molecular response, treatment-free remission, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

Patients with chronic myeloid leukaemia in chronic phase (CML-CP) who have a sustained deep molecular response (DMR) are eligible to discontinue treatment and attempt treatment-free remission (TFR). In the DASFREE study (ClinicalTrials.gov; NCT01850004), the 2-year TFR rate after dasatinib discontinuation was 46%; here we present the 5-year update. Patients with a stable DMR after ≥2 years of dasatinib therapy discontinued treatment and were followed for 5 years. At a minimum follow-up of 60 months, in 84 patients discontinuing dasatinib, the 5-year TFR rate was 44% (n = 37). No relapses occurred after month 39 and all evaluable patients who relapsed and restarted dasatinib (n = 46) regained a major molecular response in a median of 1.9 months. The most common adverse event during the off-treatment period was arthralgia (18%, 15/84); a total of 15 withdrawal events were reported in nine patients (11%). At the 5-year final follow-up, almost half of the patients who discontinued dasatinib after a sustained DMR maintained TFR. All evaluable patients who experienced a relapse quickly regained a DMR after restarting dasatinib, demonstrating that dasatinib discontinuation is a viable and potentially long-term option in patients with CML-CP. The safety profile is consistent with the previous report.

Published
2023

5. Dose modification dynamics of ponatinib in patients with chronic-phase chronic myeloid leukemia (CP-CML) from the PACE and OPTIC trials

Author

Jabbour, Elias, Apperley, Jane, Cortes, Jorge, Rea, Delphine, Deininger, Michael, Abruzzese, Elisabetta, Chuah, Charles, DeAngelo, Daniel J., Hochhaus, Andreas, Lipton, Jeffrey H., Mauro, Michael, Nicolini, Franck, Pinilla-Ibarz, Javier, Rosti, Gianantonio, Rousselot, Philippe, Shah, Neil P., Talpaz, Moshe, Vorog, Alexander, Ren, Xiaowei, and Kantarjian, Hagop

Published
2024
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7. Correction: Dose modification dynamics of ponatinib in patients with chronic-phase chronic myeloid leukemia (CP-CML) from the PACE and OPTIC trials

Author

Jabbour, Elias, Apperley, Jane, Cortes, Jorge, Rea, Delphine, Deininger, Michael, Abruzzese, Elisabetta, Chuah, Charles, DeAngelo, Daniel J., Hochhaus, Andreas, Lipton, Jeffrey H., Mauro, Michael, Nicolini, Franck, Pinilla-Ibarz, Javier, Rosti, Gianantonio, Rousselot, Philippe, Shah, Neil P., Talpaz, Moshe, Vorog, Alexander, Ren, Xiaowei, and Kantarjian, Hagop

Published
2024
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16. Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial

Author

Brümmendorf, Tim H., Cortes, Jorge E., Milojkovic, Dragana, Gambacorti-Passerini, Carlo, Clark, Richard E., le Coutre, Philipp, Garcia-Gutierrez, Valentin, Chuah, Charles, Kota, Vamsi, Lipton, Jeffrey H., Rousselot, Philippe, Mauro, Michael J., Hochhaus, Andreas, Hurtado Monroy, Rafael, Leip, Eric, Purcell, Simon, Yver, Anne, Viqueira, Andrea, and Deininger, Michael W.

Published
2022
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20. Incidence, outcomes, and risk factors of pleural effusion in patients receiving dasatinib therapy for Philadelphia chromosome-positive leukemia

Author

Hughes, Timothy P, Laneuville, Pierre, Rousselot, Philippe, Snyder, David S, Rea, Delphine, Shah, Neil P, Paar, David, Abruzzese, Elisabetta, Hochhaus, Andreas, Lipton, Jeffrey H, and Cortes, Jorge E

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Orphan Drug, Pediatric Research Initiative, Pediatric, Clinical Trials and Supportive Activities, Hematology, Childhood Leukemia, Pediatric Cancer, Rare Diseases, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Dasatinib, Disease-Free Survival, Female, Humans, Incidence, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Male, Middle Aged, Pleural Effusion, Malignant, Risk Factors, Survival Rate, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

Dasatinib, a second-generation BCR-ABL1 tyrosine kinase inhibitor, is approved for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia, both as first-line therapy and after imatinib intolerance or resistance. While generally well tolerated, dasatinib has been associated with a higher risk for pleural effusions. Frequency, risk factors, and outcomes associated with pleural effusion were assessed in two phase 3 trials (DASISION and 034/Dose-optimization) and a pooled population of 11 trials that evaluated patients with chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia treated with dasatinib (including DASISION and 034/Dose-optimization). In this largest assessment of patients across the dasatinib clinical trial program (N=2712), pleural effusion developed in 6-9% of patients at risk annually in DASISION, and in 5-15% of patients at risk annually in 034/Dose-optimization. With a minimum follow up of 5 and 7 years, drug-related pleural effusion occurred in 28% of patients in DASISION and in 33% of patients in 034/Dose-optimization, respectively. A significant risk factor identified for developing pleural effusion by a multivariate analysis was age. We found that overall responses to dasatinib, progression-free survival, and overall survival were similar in patients who developed pleural effusion and in patients who did not. clinicaltrials.gov identifier 00481247; 00123474.

Published
2019

22. Ponatinib dose-ranging study in chronic-phase chronic myeloid leukemia: a randomized, open-label phase 2 clinical trial

Author

Cortes, Jorge, Apperley, Jane, Lomaia, Elza, Moiraghi, Beatriz, Undurraga Sutton, Maria, Pavlovsky, Carolina, Chuah, Charles, Sacha, Tomasz, Lipton, Jeffrey H., Schiffer, Charles A., McCloskey, James, Hochhaus, Andreas, Rousselot, Philippe, Rosti, Gianantonio, de Lavallade, Hugues, Turkina, Anna, Rojas, Christine, Arthur, Christopher Kevin, Maness, Lori, Talpaz, Moshe, Mauro, Michael, Hall, Tracey, Lu, Vickie, Srivastava, Shouryadeep, and Deininger, Michael

Published
2021
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24. Choosing Between Older Matched Sibling Donor and Younger Matched Unrelated Donor in Allogeneic Hematopoietic Cell Transplantation: Comparison of Clinical Outcomes in Acute Myeloid Leukemia and Myelodysplastic Syndrome

Author

Pereira, Mariana Pinto, Remberger, Mats, Chen, Carol, Gerbitz, Armin, Kim, Dennis Dong Hwan, Kumar, Rajat, Lam, Wilson, Law, Arjun Datt, Lipton, Jeffrey H., Michelis, Fotios V., Novitzky-Basso, Igor, Viswabandya, Auro, Mattsson, Jonas, and Pasic, Ivan

Published
2023
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28. Impact of cytomegalovirus (CMV) seroconversion pre‐allogeneic hematopoietic cell transplantation on posttransplant outcomes.

Author

Sayyed, Ayman, Wilson, Leeann, Stavi, Vered, Chen, Shiyi, Chen, Carol, Mattsson, Jonas, Lipton, Jeffrey H., Kim, Dennis D., Viswabandya, Auro, Kumar, Rajat, Lam, Wilson, Law, Arjun D., Gerbitz, Armin, Pasic, Ivan, Novitzky‐Basso, Igor, Mazzulli, Tony, and Michelis, Fotios V.

Subjects
HEMATOPOIETIC stem cell transplantation, STEM cell transplantation, IMMUNOGLOBULIN M, IMMUNOGLOBULIN G, SEROCONVERSION, HIV seroconversion
Abstract

Cytomegalovirus (CMV) reactivation post‐allogeneic hematopoietic cell transplantation (post‐alloHCT) increases morbidity and mortality. We sought to determine the frequency of CMV seroconversion in patients pre‐alloHCT and to investigate the impact on posttransplant outcomes. We retrospectively investigated 752 adult patients who underwent alloHCT at our center from January 2015 to February 2020 before the adoption of letermovir prophylaxis. CMV serology was assessed at consult and pretransplant. The cohort was divided into four groups based on pretransplant CMV seroconversion: negative to positive (Group 1), positive to negative (Group 2), consistently negative (Group 3), and consistently positive (Group 4). Eighty‐nine patients (12%) had seroconverted from negative to positive, 17 (2%) from positive to negative, 151 (20%) were consistently seronegative, and 495 (66%) were consistently seropositive pretransplant. For the four CMV serostatus groups, cumulative incidence of CMV reactivation at 6 months posttransplant was 4.5%, 47.1%, 6.6%, and 76.6% for Groups 1, 2, 3, and 4, respectively (p <.0001). No differences between groups were seen regarding Grade III–IV acute graft‐versus‐host disease (GVHD) (p =.91), moderate/severe chronic GVHD (p =.41), or graft failure (p =.28). On multivariable analysis, there was no impact of CMV serostatus group on overall survival (p =.67), cumulative incidence of relapse (p =.83) or non‐relapse mortality. alloHCT patients who demonstrate CMV seroconversion pretransplant from negative to positive have a very low risk of CMV reactivation posttransplant. The observed seroconversion may be due to passive CMV immunity acquired through blood products. Quantitative CMV immunoglobulin G/immunoglobulin M pretransplant may help differentiate between true seroconversion and passively transmitted CMV immunoglobulin. [ABSTRACT FROM AUTHOR]

Published
2024
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29. Life Is a Highway or a Long and Winding Road: A Look into Why Some Transplants Lead to Longer Length of Stay (LOS)

Author

Sayyed, Ayman, primary, Remberger, Mats, additional, Clarke, Susan, additional, Chen, Carol, additional, Lipton, Jeffrey H, additional, Kim, Dennis (Dong Hwan), additional, Viswabandya, Auro, additional, Kumar, Rajat, additional, Lam, Wilson, additional, Law, Arjun D., additional, Gerbitz, Armin, additional, Pasic, Ivan, additional, Novitzky-Basso, Igor, additional, Michelis, Fotios V., additional, and Mattsson, Jonas, additional

Published
2024
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30. Impact of Letermovir on Outcomes in Cytomegalovirus Seropositive Patients Undergoing Allogeneic HCT: Exploring Outcomes across Ethnicities

Author

Singhabahu, Sanjay, primary, Herrity, Elizabeth, additional, Remberger, Mats, additional, Pang, Ian, additional, Novitzky-Basso, Igor, additional, Pasic, Ivan, additional, Lam, Wilson, additional, Law, Arjun D., additional, Viswabandya, Auro, additional, Gerbitz, Armin, additional, Kumar, Rajat, additional, Kim, Dennis Dong Hwan, additional, Lipton, Jeffrey H, additional, Mattsson, Jonas, additional, and Michelis, Fotios V., additional

Published
2024
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31. Exploring Outcomes By Ethnicity in Allogeneic Hematopoietic Cell Transplantation

Author

Herrity, Elizabeth, primary, Singhabahu, Sanjay, additional, Remberger, Mats, additional, Novitzky-Basso, Igor, additional, Pasic, Ivan, additional, Lam, Wilson, additional, Law, Arjun D., additional, Viswabandya, Auro, additional, Gerbitz, Armin, additional, Kumar, Rajat, additional, Kim, Dennis Dong Hwan, additional, Lipton, Jeffrey H, additional, Mattsson, Jonas, additional, and Michelis, Fotios V., additional

Published
2024
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32. A Single Center Experience of Central Nervous System Manifestations of Graft Versus Host Disease.

Author

Khaire, Niranjan S, primary, Cyriac, Sunu, additional, Nampoothiri, Ram Vasudevan, additional, Gerbitz, Armin, additional, Kim, Dennis (Dong Hwan), additional, Kumar, Rajat, additional, Lam, Wilson, additional, Law, Arjun D., additional, Lipton, Jeffrey H, additional, Pasic, Ivan, additional, Michelis, Fotios V., additional, Novitzky-Basso, Igor, additional, Mattsson, Jonas, additional, and Viswabandya, Auro, additional

Published
2024
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36. Letermovir prophylaxis for cytomegalovirus reactivation in allogeneic hematopoietic cell transplant recipients : Single center Canadian data

Author

Pang, Ian, Chen, Peggy, Trinh, Gertrude V., Remberger, Mats, Novitzky-Basso, Igor, Gerbitz, Armin, Kim, Dennis D., Kumar, Rajat, Lam, Wilson, Law, Arjun D., Lipton, Jeffrey H., Viswabandya, Auro, Pasic, Ivan, Mattsson, Jonas, Michelis, Fotios V., Pang, Ian, Chen, Peggy, Trinh, Gertrude V., Remberger, Mats, Novitzky-Basso, Igor, Gerbitz, Armin, Kim, Dennis D., Kumar, Rajat, Lam, Wilson, Law, Arjun D., Lipton, Jeffrey H., Viswabandya, Auro, Pasic, Ivan, Mattsson, Jonas, and Michelis, Fotios V.

Abstract

Background: Cytomegalovirus (CMV) is associated with morbidity and mortality following allogeneic hematopoietic cell transplantation (alloHCT). Letermovir is a novel antiviral agent that prevents CMV reactivation in alloHCT patients, with limited data regarding influence on post-alloHCT outcomes. Methods: We retrospectively examined 273 alloHCT recipients, 158 in the non-letermovir cohort (NLC), and 115 in the cohort using letermovir prophylaxis (LC). Patients that received letermovir were CMV-seropositive and met criteria for high risk of CMV reactivation. Results: Median start of letermovir was 21 days post-alloHCT, median duration of prophylaxis was 86 days. Letermovir prophylaxis demonstrated a statistically significant reduction in first CMV reactivation (at 200 days post 63.9% in the NLC vs. 35.7% in the LC; p < .001). On univariate analysis at 1 year, overall survival (OS) for NLC was 79.6% and 79.5% for LC (p = .54). Non relapse mortality (NRM) at 1 year for NLC was 12% and 12.3% for LC (p = .69). Cumulative incidence of relapse (CIR) at 1 year was 13.9% for NLC versus 17.1 for the LC (p = .27). On multivariable analysis, there was no significant difference between the two cohorts for OS, NRM, and CIR. Conclusions: Letermovir prophylaxis started at day +21 post-alloHCT reduced CMV reactivation, with no impact on posttransplant outcomes.

Published
2024
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43. Stem cell allografting for chronic Myeloid leukemia in the tyrosine kinase era – forgotten but not gone.

Author

Tang, Kenny and Lipton, Jeffrey H.

Subjects
*CHRONIC myeloid leukemia, *PROTEIN-tyrosine kinases, *STEM cell transplantation, *STEM cells, *PROTEIN-tyrosine kinase inhibitors, *DASATINIB, *NILOTINIB
Abstract

Due to the remarkable success of tyrosine kinase inhibitors (TKI) in chronic myeloid leukemia (CML), allogeneic stem cell transplantation (alloSCT) is not first-line treatment for delivering durable, long-term survival. Consequently, alloSCT is reserved for patients with TKI-resistant or TKI-intolerant chronic phase CML (CP-CML) and advanced phase CML (AP-CML). Advances in transplant technology, such as high-resolution HLA typing, introduction of reduced intensity conditioning and increased alternative donor availability, coupled with improved supportive care, have significantly reduced transplant-related mortality and expanded the pool of transplant-eligible patients. Refinement of conditioning regimens, innovative use of post-transplant cellular and pharmacological therapies, and judicious post-transplant monitoring are important strategies for reducing risk of relapse. Given its potential to cure, alloSCT will invariably remain a key part of the treatment algorithm. This article reviews the data underpinning the role and outcomes of alloSCT and provides an update on current recommendations. [ABSTRACT FROM AUTHOR]

Published
2024
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44. CML-046 Dose Modification Dynamics of Ponatinib in Patients With Chronic-Phase Chronic Myeloid Leukemia From the PACE and OPTIC Trials

Author

Apperley, Jane, Kantarjian, Hagop, Deininger, Michael, Abruzzese, Elisabetta, Cortes, Jorge, Chuah, Charles, DeAngelo, Daniel J., DiPersio, John, Hochhaus, Andreas, Lipton, Jeffrey H., Nicolini, Frank, Pinilla-Ibarz, Javier, Rea, Delphine, Rosti, Gianantonio, Rousselot, Philippe, Mauro, Michael, Shah, Neil, Talpaz, Moshe, Vorog, Alexander, Ren, Xiaowei, and Jabbour, Elias

Published
2022
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50. Letermovir prophylaxis for cytomegalovirus reactivation in allogeneic hematopoietic cell transplant recipients: Single center Canadian data

Author

Pang, Ian, primary, Chen, Peggy, additional, Trinh, Gertrude V., additional, Remberger, Mats, additional, Novitzky‐Basso, Igor, additional, Gerbitz, Armin, additional, Kim, Dennis D., additional, Kumar, Rajat, additional, Lam, Wilson, additional, Law, Arjun D., additional, Lipton, Jeffrey H., additional, Viswabandya, Auro, additional, Pasic, Ivan, additional, Mattsson, Jonas, additional, and Michelis, Fotios V., additional

Published
2023
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