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1.
Blood ; 138(SUPPL 1):3525, 2021.
Article in English | EMBASE | ID: covidwho-1770434

ABSTRACT

Background - The WINDOW-1 regimen introduced first-line ibrutinib with rituximab (IR) followed by 4 cycles of R-HCVAD for younger mantle cell lymphoma (MCL) patients (pts) demonstrating 90% CR on IR alone and we aimed to improve the CR rate with the addition of venetoclax. We therefore investigated the efficacy and safety of IR and venetoclax (IRV) followed by risk-stratified observation or short course R-HCVAD/MTX-ARA-C as consolidation in previously untreated young patients with mantle cell lymphoma (MCL). Our aim was to use a triplet chemotherapy-free induction to reduce the toxicity, complications and minimize chemotherapy exposure in MCL pts. Methods - We enrolled 50 previously untreated pts in this single institution, single arm, phase II clinical trial - NCT03710772. Pts received IR induction (Part-1) for initial 4 cycles. Pts were restaged at cycle 4 and received IRV for up to eight cycles (Cycle 5 to Cycle 12) starting with ramp up venetoclax dosing in Cycle 5. All pts who achieved CR prior to cycle 12 continued to receive IRV for 4 cycles (maximum 12 cycles) and then moved to part 2. Pts were stratified into three disease risk groups: high, moderate and low risk categories from the baseline data for assignment to R-HCVAD/MTX-ARA-C as consolidation in part 2 (4 cycles, 2 cycles, or no chemotherapy for high, medium and low risk pts respectively). Briefly, low risk pts were those with Ki-67 ≤30%, largest tumor mass <3 cm, low MIPI score and no features of high risk disease (Ki-67 ≥50%, mutations in the TP53, NSD2 or in NOTCH genes, complex karyotype or del17p, MYC positive, or largest tumor diameter >5 cm or blastoid/pleomorphic histology or if they remain in PR after 12 cycles of part 1. Medium risk are pts which did not belong to low or high-risk category. Those who experienced progression on part 1 went to part 2 and get 4 cycles of part 2. Patient were taken off protocol but not off study, if they remained in PR after 4 cycles of chemotherapy, these patients were followed up for time to next treatment and progression free survival on subsequent therapies. After part 2 consolidation, all pts received 2 years of IRV maintenance. The primary objective was to assess CR rates after IRV induction. Adverse events were coded as per CTCAE version 4. Molecular studies are being performed. Results - Among the 50 pts, the median age was 57 years (range - 35-65). There were 20 pts in high-risk group, 20 pts in intermediate-risk group and 10 pts in low-risk group. High Ki-67 (≥30%) in 18/50 (36%) pts. Eighteen (36%) had high and intermediate risk simplified MIPI scores. Six (12%) pts had aggressive MCL (blastoid/pleomorphic). Among the 24 TP53 evaluable pts, eight pts (33%) had TP53 aberrations (mutated and/or TP53 deletion by FISH). Forty-eight pts received IRV. Best response to IRV was 96% and CR of 92%. After part 2, the best ORR remained unaltered, 96% (92% CR and 4% PR). The median number of cycles of triplet IRV to reach best response was 8 cycles (range 2-12). Fifteen pts (30%) did not receive part 2 chemotherapy, two pts (4%) received 1 cycle, 16 pts (32%) 2 cycles and 13 pts (26%) got 4 cycles of chemotherapy. With a median follow up of 24 months, the median PFS and OS were not reached (2 year 92% and 90% respectively). The median PFS and OS was not reached and not significantly different in pts with high and low Ki-67% or with/without TP53 aberrations or among pts with low, medium or high-risk categories. The median PFS and OS was inferior in blastoid/pleomorphic MCL pts compared to classic MCL pts (p=0.01 and 0.03 respectively). Thirteen pts (26%) came off study - 5 for adverse events, 3 for on study deaths, and 2 for patient choice, 2 patients lost to follow up and one for disease progression. Overall, 5 pts died (3 on trial and 2 pts died off study, one due to progressive disease and another due to COVID pneumonia). Grade 3-4 toxicities on part 1 were 10% myelosuppression and 10% each with fatigue, myalgia and rashes and 3% mucositis. One pt developed grade 3 atrial flutter on part 1. None had grade 3-4 bleeding/bruising. Conclusions - Chemotherapy-free induction with IRV induced durable and deep responses in young MCL pts in the frontline setting. WINDOW-2 approach suggests that pts with low risk MCL do not need chemotherapy but further follow up is warranted. This combined modality treatment approach significantly improves outcomes of young MCL pts across all risk groups. Detailed molecular analyses will be reported. (Figure Presented).

2.
Blood ; 138:2626, 2021.
Article in English | EMBASE | ID: covidwho-1582154

ABSTRACT

Background: Dysfunction of T cells, NK cells and other immune subsets is common in patients (pts) with CLL. Venetoclax (VEN), a BCL-2 inhibitor and obinutuzumab (OBIN), a CD20 monoclonal antibody (mAb) are approved for pts with CLL (Fischer, NEJM 2019). Atezolizumab, a PD-L1 checkpoint inhibitor (CPI), is approved for melanoma, lung cancer and other solid tumors. Preclinical studies showed synergy of VEN and CD20 mAb with CPI (Kohlhapp, Cancer Discovery 2021;Westin, Lancet Oncology 2014). Clinical studies showed activity of PD1 inhibition in pts with Richter's transformation, but not CLL (Ding, Blood 2017;Jain, ASH 2018). To our knowledge, no prior study has evaluated PD-L1 inhibition in pts with CLL, nor combined CPI, VEN and OBIN. We hypothesized that combined VEN, OBIN and atezolizumab will be synergistic. Methods: This is an investigator-initiated Phase II trial of combined VEN, OBIN and atezolizumab in pts with previously untreated CLL meeting 2008 IWCLL treatment criteria (NCT02846623). Eligibility criteria included age ≥18 years, adequate organ function (total bilirubin ≤1.5 x ULN, ALT and AST ≤2.5 x ULN, creatinine ≤1.5 x ULN). OBIN was given at a flat dose of 100mg IV Cycle (C)1 Day (D)1, 900 mg C1D2, 1000mg on C1D8, 1000mg on C1D15 and then 1000mg on C2-9 D1. Atezolizumab was given at a flat dose of 1680 mg IV (split over 2 days) on C1D3-4 and then C2-9D1-2. VEN was initiated at the start of C3 with the weekly dose-escalation (20mg daily to a target dose of 400mg daily) and continued daily until end of C14 (total 12 cycles of VEN). All pts stopped therapy at the end of C14. Response assessments were done with CT imaging and bone marrow aspirate/biopsy with MRD assessment (multi-color flow cytometry;sensitivity 10 -4) at the end of C2 (prior to VEN initiation), end of C6, end of C9, and end of C14. Results: From July 2019 to December 2020, a total of 26 pts were enrolled. The median age was 60 years (range, 21-74). The baseline characteristics are shown in Table 1. A total of 19/26 (73%) had unmutated IGHV gene. Though the study did not restrict pts with del(17p) or mutated TP53, no pt in the current cohort had del(17p)/ mutated TP53. A total of 14 (54%) pts had a baseline lymph node >5cm. The median follow-up is 13.3 months. One pt came off study in C1 (details below). A total of 25 pts initiated VEN. The TLS risk categories at the start of C1 were high (n=9, 36%), medium (n=12, 48%), and low (n=4, 16%). After 2 cycles of OBIN and atezolizumab (prior to VEN initiation), the majority of pts had downgrading of TLS risk category [high (n=2, 8%), medium (n=3, 12%), and low (n=20, 80%)]. After C6 (about 3 cycles of VEN 400mg daily), bone marrow undetectable (U)-MRD rate was 19/25 (76%);4/25 (16%) had low+ MRD and 2/25 (8%) had high+ MRD. After C9 (about 6 cycles of VEN 400mg daily), among the 21 pts (4 pts have not reached this time-point), the bone marrow U-MRD rate was 18/21 (86%);2/21 (10%) had low+ MRD and 1/21 (5%) had high+ MRD. A total of 14 pts completed C14 (9 pts have not reached this time-point;2 pts came off study prior to completing C14, details below);13/14 (93%) achieved bone marrow U-MRD and 1/14 (7%) has low+ MRD. No patient had disease progression or MRD relapse so far. One pt died (details below). Three pts came off study (one developed retroperitoneal hematoma after receiving enoxaparin for DVT in C1;one developed CPI-induced colitis and removed from the study in C10;one died from COVID-19 pneumonia in C14 while in bone marrow U-MRD remission). Grade 3-4 neutropenia occurred in 14/26 (54%) pts. Grade 3 thrombocytopenia occurred in 5/26 (19%) pts;no pt had G4 thrombocytopenia. A total of 4 pts developed CPI-induced toxicities (colitis, G3, n=1;mucositis, G3, n=1;nephritis, G2, n=1;myositis, G2, n=1). A total of 10/25 (40%) pts had dose reduction of VEN, the majority due to neutropenia. Atezolizumab was discontinued early in 3 pts due to CPI-induced toxicities. Laboratory correlative studies including scRNAseq and CyTOF are ongoing. Conclusions: Treatment with combined VE , OBIN and atezolizumab leads to high rate of early U-MRD remission with 76% bone marrow U-MRD remission at the end of C6 (about 3 cycles of VEN 400mg daily). Four pts had CPI-induced toxicities. The enrollment in this trial continues and updated data and correlative studies will be presented at the ASH meeting. [Formula presented] Disclosures: Jain: Pfizer: Research Funding;Bristol Myers Squibb: Honoraria, Research Funding;Precision Biosciences: Honoraria, Research Funding;Aprea Therapeutics: Research Funding;AstraZeneca: Honoraria, Research Funding;Servier: Honoraria, Research Funding;Incyte: Research Funding;Pharmacyclics: Research Funding;Genentech: Honoraria, Research Funding;AbbVie: Honoraria, Research Funding;TG Therapeutics: Honoraria;Janssen: Honoraria;Beigene: Honoraria;Fate Therapeutics: Research Funding;Adaptive Biotechnologies: Honoraria, Research Funding;Cellectis: Honoraria, Research Funding;ADC Therapeutics: Honoraria, Research Funding. Ferrajoli: Janssen: Other: Advisory Board;AstraZeneca: Other: Advisory Board, Research Funding;BeiGene: Other: Advisory Board, Research Funding. Yilmaz: Daiichi-Sankyo: Research Funding;Pfizer: Research Funding. Thompson: AbbVie: Other: Institution: Advisory/Consultancy, Honoraria, Research Grant/Funding;Gilead: Other: Institution: Advisory/Consultancy, Honoraria;Janssen: Consultancy, Honoraria;Pharmacyclics: Other: Institution: Advisory/Consultancy, Honoraria, Research Grant/Funding;Adaptive Biotechnologies: Other: Institution: Advisory/Consultancy, Honoraria, Research Grant/Funding, Expert Testimony;Genentech: Other: Institution: Advisory/Consultancy, Honoraria, Research Grant/Funding;Amgen: Other: Institution: Honoraria, Research Grant/Funding. Konopleva: Novartis: Other: research funding pending, Patents & Royalties: intellectual property rights;Reata Pharmaceuticals: Current holder of stock options in a privately-held company, Patents & Royalties: intellectual property rights;Eli Lilly: Patents & Royalties: intellectual property rights, Research Funding;KisoJi: Research Funding;Stemline Therapeutics: Research Funding;Sanofi: Other: grant support, Research Funding;Rafael Pharmaceuticals: Other: grant support, Research Funding;AstraZeneca: Other: grant support, Research Funding;Cellectis: Other: grant support;F. Hoffmann-La Roche: Consultancy, Honoraria, Other: grant support;Calithera: Other: grant support, Research Funding;Ascentage: Other: grant support, Research Funding;Ablynx: Other: grant support, Research Funding;Genentech: Consultancy, Honoraria, Other: grant support, Research Funding;Forty Seven: Other: grant support, Research Funding;AbbVie: Consultancy, Honoraria, Other: Grant Support, Research Funding;Agios: Other: grant support, Research Funding. Neelapu: Takeda Pharmaceuticals and related to cell therapy: Patents & Royalties;Kite, a Gilead Company, Bristol Myers Squibb, Merck, Poseida, Cellectis, Celgene, Karus Therapeutics, Unum Therapeutics (Cogent Biosciences), Allogene, Precision BioSciences, Acerta and Adicet Bio: Research Funding;Kite, a Gilead Company, Merck, Bristol Myers Squibb, Novartis, Celgene, Pfizer, Allogene, Kuur, Incyte, Precision BioSciences, Legend, Adicet Bio, Calibr, and Unum Therapeutics: Other: personal fees;Kite, a Gilead Company, Merck, Bristol Myers Squibb, Novartis, Celgene, Pfizer, Allogene Therapeutics, Cell Medica/Kuur, Incyte, Precision Biosciences, Legend Biotech, Adicet Bio, Calibr, Unum Therapeutics and Bluebird Bio: Honoraria. Takahashi: Symbio Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees;Celgene/BMS: Consultancy;Novartis: Consultancy;GSK: Consultancy. Burger: TG Therapeutics: Other: Travel/Accommodations/Expenses, Research Funding, Speakers Bureau;Beigene: Research Funding, Speakers Bureau;Novartis: Other: Travel/Accommodations/Expenses, Speakers Bureau;Pharmacyclics LLC: Consultancy, Other: Travel/Accommodations/Expenses, Research Funding, Speakers Bureau;Gilead: Consultancy, Other: Travel/Accommodations/Expenses, Rese rch Funding, Speakers Bureau;AstraZeneca: Consultancy;Janssen: Consultancy, Other: Travel/Accommodations/Expenses, Speakers Bureau. Khoury: Stemline Therapeutics: Research Funding;Kiromic: Research Funding;Angle: Research Funding. Kantarjian: Jazz: Research Funding;NOVA Research: Honoraria;Novartis: Honoraria, Research Funding;KAHR Medical Ltd: Honoraria;Precision Biosciences: Honoraria;Amgen: Honoraria, Research Funding;Astra Zeneca: Honoraria;AbbVie: Honoraria, Research Funding;Ipsen Pharmaceuticals: Honoraria;Pfizer: Honoraria, Research Funding;Astellas Health: Honoraria;Aptitude Health: Honoraria;Taiho Pharmaceutical Canada: Honoraria;Immunogen: Research Funding;Daiichi-Sankyo: Research Funding;BMS: Research Funding;Ascentage: Research Funding. Wierda: Karyopharm: Research Funding;Miragen: Research Funding;Acerta Pharma Inc.: Research Funding;Cyclacel: Research Funding;Oncternal Therapeutics, Inc.: Research Funding;Pharmacyclics LLC, an AbbVie Company: Research Funding;Sunesis: Research Funding;Juno Therapeutics: Research Funding;Gilead Sciences: Research Funding;AstraZeneca: Research Funding;Genentech: Research Funding;Loxo Oncology, Inc.: Research Funding;Janssen: Research Funding;Xencor: Research Funding;GSK/Novartis: Research Funding;KITE Pharma: Research Funding;Genzyme Corporation: Consultancy;AbbVie: Research Funding. OffLabel Disclosure: Atezolizumab is not approved for CLL

3.
Blood ; 138:3720, 2021.
Article in English | EMBASE | ID: covidwho-1582144

ABSTRACT

Background: Ibrutinib (IBR) and venetoclax (VEN) combination is a highly effective therapy for patients (pts) with CLL (Jain, NEJM 2019;Wierda, ASH 2020;Kater, EHA 2021). We previously reported results of the first-line cohort of a phase II trial of combined IBR and VEN for high-risk pts with CLL (Jain, NEJM 2019;Jain, JAMA Oncology 2021). Here we report updated data for these pts with focus on MRD. Methods: Pts with previously untreated CLL meeting IWCLL treatment criteria were enrolled. All pts had at least one high-risk feature: del(17p), mutated TP53, del(11q), unmutated IGHV, or age ≥65 years (yrs). Pts received IBR 420 mg daily for 3 cycles followed by addition of VEN (weekly dose-escalation to 400mg daily). Combined therapy was given for 24 cycles (28 days/cycle). Pts with bone marrow (BM) undetectable MRD (U-MRD) (flow cytometry;sensitivity 10 -4) at 24 cycles of combined therapy discontinued both VEN and IBR;MRD+ pts continued IBR. A trial amendment allowed an additional 12 cycles of combined VEN and ibrutinib for pts who remained BM MRD+ after Cycle 24. Response assessments were performed using BM and CT imaging studies (2008 IWCLL criteria). U-MRD was defined as <0.01%;low MRD+ 0.01% to <1%;high MRD+ ≥1%. Progression-free survival (PFS) was assessed as the time from the start of study drug to CLL progression, Richter transformation, or death from any cause. Blood MRD was monitored every 6 months in pts off treatment or on ibrutinib monotherapy beyond 24 cycles of combined treatment. Results: A total of 80 pts were enrolled. Baseline characteristics are shown in Table 1. The median follow-up was 44.1 months. Five pts came off study during 1 st 3 cycles of IBR monotherapy;75 pts initiated VEN. We previously reported that after 12 cycles of the combination, 45/80 (56%) achieved BM U-MRD remission;24/80 (30%) were BM MRD-positive (low MRD+, n=19;high MRD+, n=5). After 24 cycles of the combination, 53/80 (66%) achieved BM U-MRD remission;14/80 (17%) were BM MRD+ (low MRD+, n=13;high MRD+, n=1). Overall, 60/80 (75%) achieved BM U-MRD as the best response. Updated PFS is provided in Figure 1. Of the 53 pts who were BM U-MRD at the end of cycle 24 of the combination, 52 pts had a subsequent blood MRD assessment done in follow-up (1 missed due to COVID-19);51/53 discontinued all therapy, 2 pts continued IBR per treatment physician discretion. With a median time of 18.4 months post Cycle 24, 8 pts had recurrence of blood MRD (defined as MRD ≥ 0.01% in 2 consecutive visits) in follow-up with 1 pt with CLL progression. The sole pt with CLL progression had mutated IGHV with del(11q) and NOTCH1 mutation. The pt had delayed achievement of BM U-MRD with the pt achieving U-MRD for the first time at the end of Cycle 24 of combined therapy. She was noted to have disease progression 22 months off therapy;BTK or PLCG2 mutation were not detected and the patient is currently in clinical remission on acalabrutinib. The time to MRD conversion for these 53 pts is shown in Figure 2. There were 14 pts who were BM MRD+ at the end of cycle 24 of the combination (low MRD+, n=13;high MRD+, n=1). The only pt with high-MRD+ at end of cycle 24 was noted to have Richter transformation at that time. The remaining 13 pts (all low MRD+ in BM, range 0.01-0.56%) continued IBR monotherapy. With a recent trial amendment, MRD+ pts after Cycle 24 could get 12 additional cycles of venetoclax;9/13 pts have resumed VEN. 6/9 pts have achieved U-MRD remission. 2 pts had Richter transformation and 3 pts have died (Jain, JAMA Oncology 2021). Conclusions: We report long term follow-up of combined IBR and VEN in first-line CLL. Remissions were durable with some pts having recurrence of blood MRD in follow-up, which may be an early indicator of relapse. In a small subset of the pts with BM MRD+ disease at 24 cycles of combined therapy, additional VEN appears to lead to U-MRD remission in majority of the pts. Whether this will lead to improved long-term PFS remains to be determined. [Formula presented] Disclosures: Jain: TG Therapeutics: Honoraria;Beigene: Honoraria;Janssen: Honoraria;Fate Therapeutics: Research Funding;Aprea Therapeutics: Research Funding;Precision Biosciences: Honoraria, Research Funding;Incyte: Research Funding;Adaptive Biotechnologies: Honoraria, Research Funding;Cellectis: Honoraria, Research Funding;ADC Therapeutics: Honoraria, Research Funding;Servier: Honoraria, Research Funding;Pfizer: Research Funding;Bristol Myers Squibb: Honoraria, Research Funding;AstraZeneca: Honoraria, Research Funding;Genentech: Honoraria, Research Funding;AbbVie: Honoraria, Research Funding;Pharmacyclics: Research Funding. Thompson: AbbVie: Other: Institution: Advisory/Consultancy, Honoraria, Research Grant/Funding;Amgen: Other: Institution: Honoraria, Research Grant/Funding;Genentech: Other: Institution: Advisory/Consultancy, Honoraria, Research Grant/Funding;Adaptive Biotechnologies: Other: Institution: Advisory/Consultancy, Honoraria, Research Grant/Funding, Expert Testimony;Pharmacyclics: Other: Institution: Advisory/Consultancy, Honoraria, Research Grant/Funding;Janssen: Consultancy, Honoraria;Gilead: Other: Institution: Advisory/Consultancy, Honoraria. Ferrajoli: BeiGene: Other: Advisory Board, Research Funding;Janssen: Other: Advisory Board;AstraZeneca: Other: Advisory Board, Research Funding. Burger: Novartis: Other: Travel/Accommodations/Expenses, Speakers Bureau;TG Therapeutics: Other: Travel/Accommodations/Expenses, Research Funding, Speakers Bureau;Janssen: Consultancy, Other: Travel/Accommodations/Expenses, Speakers Bureau;Beigene: Research Funding, Speakers Bureau;Pharmacyclics LLC: Consultancy, Other: Travel/Accommodations/Expenses, Research Funding, Speakers Bureau;Gilead: Consultancy, Other: Travel/Accommodations/Expenses, Research Funding, Speakers Bureau;AstraZeneca: Consultancy. Borthakur: GSK: Consultancy;ArgenX: Membership on an entity's Board of Directors or advisory committees;University of Texas MD Anderson Cancer Center: Current Employment;Protagonist: Consultancy;Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees;Astex: Research Funding;Ryvu: Research Funding;Takeda: Membership on an entity's Board of Directors or advisory committees. Takahashi: Symbio Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees;Novartis: Consultancy;Celgene/BMS: Consultancy;GSK: Consultancy. Sasaki: Daiichi-Sankyo: Membership on an entity's Board of Directors or advisory committees;Pfizer: Membership on an entity's Board of Directors or advisory committees;Novartis: Consultancy, Research Funding. Kadia: Cellonkos: Other;Aglos: Consultancy;Dalichi Sankyo: Consultancy;AbbVie: Consultancy, Other: Grant/research support;BMS: Other: Grant/research support;Amgen: Other: Grant/research support;Cure: Speakers Bureau;Jazz: Consultancy;Genentech: Consultancy, Other: Grant/research support;Liberum: Consultancy;Novartis: Consultancy;Pfizer: Consultancy, Other;Pulmotech: Other;Sanofi-Aventis: Consultancy;AstraZeneca: Other;Astellas: Other;Genfleet: Other;Ascentage: Other. Konopleva: Sanofi: Other: grant support, Research Funding;Cellectis: Other: grant support;Calithera: Other: grant support, Research Funding;KisoJi: Research Funding;Agios: Other: grant support, Research Funding;Ascentage: Other: grant support, Research Funding;AbbVie: Consultancy, Honoraria, Other: Grant Support, Research Funding;Ablynx: Other: grant support, Research Funding;Stemline Therapeutics: Research Funding;Eli Lilly: Patents & Royalties: intellectual property rights, Research Funding;AstraZeneca: Other: grant support, Research Funding;Rafael Pharmaceuticals: Other: grant support, Research Funding;Genentech: Consultancy, Honoraria, Other: grant support, Research Funding;F. Hoffmann-La Roche: Consultancy, Honoraria, Other: grant support;Forty Seven: Other: grant support, Research Funding;Novartis: Other: research funding pending, Patents & Royalties: intellectual property rights;Reata Pharmaceuticals: Current holder of stock options in a privately-held company, Patents & Royalties: intellectual property rights. Alvarado: BerGenBio: Research Funding;Jazz Pharmaceuticals: Research Funding;Astex Pharmaceuticals: Research Funding;Sun Pharma: Consultancy, Research Funding;MEI Pharma: Research Funding;FibroGen: Research Funding;Daiichi-Sankyo: Research Funding;CytomX Therapeutics: Consultancy. Yilmaz: Pfizer: Research Funding;Daiichi-Sankyo: Research Funding. DiNardo: Notable Labs: Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees;Novartis: Honoraria;Takeda: Honoraria;Celgene, a Bristol Myers Squibb company: Honoraria, Research Funding;Forma: Honoraria, Research Funding;AbbVie: Consultancy, Research Funding;GlaxoSmithKline: Membership on an entity's Board of Directors or advisory committees;Bristol Myers Squibb: Honoraria, Research Funding;ImmuneOnc: Honoraria, Research Funding;Agios/Servier: Consultancy, Honoraria, Research Funding;Foghorn: Honoraria, Research Funding. Bose: Kartos Therapeutics: Honoraria, Research Funding;Sierra Oncology: Honoraria;Novartis: Honoraria;Constellation Pharmaceuticals: Research Funding;NS Pharma: Research Funding;Celgene Corporation: Honoraria, Research Funding;Blueprint Medicines: Honoraria, Research Funding;Pfizer: Research Funding;Promedior: Research Funding;Astellas: Research Funding;Incyte Corporation: Honoraria, Research Funding;BMS: Honoraria, Research Funding;CTI BioPharma: Honoraria, Research Funding. Pemmaraju: Blueprint Medicines: Consultancy;LFB Biotechnologies: Consultancy;Novartis Pharmaceuticals: Consultancy, Other: Research Support, Research Funding;ASCO Leukemia Advisory Panel: Membership on an entity's Board of Directors or advisory committees;Dan's House of Hope: Membership on an entity's Board of Directors or advisorycommittees;Roche Diagnostics: Consultancy;MustangBio: Consultancy, Other;Affymetrix: Consultancy, Research Funding;Samus: Other, Research Funding;ImmunoGen, Inc: Consultancy;ASH Communications Committee: Membership on an entity's Board of Directors or advisory committees;Aptitude Health: Consultancy;Plexxicon: Other, Research Funding;Springer Science + Business Media: Other;Protagonist Therapeutics, Inc.: Consultancy;HemOnc Times/Oncology Times: Membership on an entity's Board of Directors or advisory committees;Clearview Healthcare Partners: Consultancy;Abbvie Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding;CareDx, Inc.: Consultancy;Sager Strong Foundation: Other;Daiichi Sankyo, Inc.: Other, Research Funding;Incyte: Consultancy;Stemline Therapeutics, Inc.: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding;Bristol-Myers Squibb Co.: Consultancy;DAVA Oncology: Consultancy;Pacylex Pharmaceuticals: Consultancy;Celgene Corporation: Consultancy;Cellectis S.A. ADR: Other, Research Funding. Jabbour: Amgen, AbbVie, Spectrum, BMS, Takeda, Pfizer, Adaptive, Genentech: Research Funding. Wang: Stemline Therapeutics: Honoraria. Kantarjian: Taiho Pharmaceutical Canada: Honoraria;Precision Biosciences: Honoraria;Immunogen: Research Funding;Daiichi-Sankyo: Research Funding;Jazz: Research Funding;BMS: Research Funding;AbbVie: Honoraria, Research Funding;Pfizer: Honoraria, Research Funding;Novartis: Honoraria, Research Funding;NOVA Research: Honoraria;KAHR Medical Ltd: Honoraria;Ipsen Pharmaceuticals: Honoraria;Astra Zeneca: Honoraria;Astellas Health: Honoraria;Aptitude Health: Honoraria;Amgen: Honoraria, Research Funding;Ascentage: Research Funding. Wierda: Juno Therapeutics: Research Funding;AstraZeneca: Research Funding;Xencor: Research Funding;Janssen: Research Funding;Loxo Oncology, Inc.: Research Funding;Cyclacel: Research Funding;Oncternal Therapeutics, Inc.: Research Funding;Miragen: Research Funding;KITE Pharma: Research Funding;Sunesis: Research Funding;Gilead Sciences: Research Funding;Acerta Pharma Inc.: Rese rch Funding;Pharmacyclics LLC, an AbbVie Company: Research Funding;Karyopharm: Research Funding;Genentech: Research Funding;GSK/Novartis: Research Funding;Genzyme Corporation: Consultancy;AbbVie: Research Funding. OffLabel Disclosure: The combination of ibrutinib and venetoclax is not FDA approved

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