bluuebunny/crossref_metadata_2025_split huggingface dataset:
Real-world outcomes by race in patients (pts) with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Final analysis results from the informCLL registry.
Authors: Barrientos Jacqueline Claudia , Sharman Jeff Porter , Gutierrez Meghan E. , Wu Linda , Qureshi Zaina P. , Raz Anat , Girardi Vincent , Naganuma Maoko , Ghosh Nilanjan 
Published: June 2023

7536 Background: informCLL is a large, US-based, prospective, observational registry of pts with CLL/SLL initiating treatment (tx) in the era after approval of ibrutinib (Ibr). Here, we report real-world tx patterns and outcomes by race and line of therapy (LOT) from the final analysis of informCLL. Methods: Pts with CLL/SLL who initiated FDA-approved tx were enrolled between 10/2015 and 6/2019. Baseline characteristics, tx patterns, time to next tx (TTNT), OS, and safety are summarized by race (focus on Black and White pts) and LOT (first-line [1L] or relapsed/refractory [R/R], with focus on 1L). Results: Of 1459 eligible pts enrolled, 105 were Black (1L, n=58; R/R, n=47), 1323 were White (1L, n=779; R/R, n=544), and 31 were of other races (Asian [n=6], Native American [n=4], other/not reported [n=21]). Relative to White pts, 1L-treated Black pts were younger (median age 65 vs 70 y) and had worse performance status (ECOG status ≥1: 59% vs 50%), more advanced disease (Rai stage III-IV: 55% vs 46%), shorter time from diagnosis to 1L tx (median 7 vs 19 mo), and lower rates of del(17p) among tested pts (6% vs 13%). Across race, Ibr was the most common 1L tx (Black, n=29 [50%]; White, n=346 [44%]) followed by CIT (Black, n=25 [43%]; White, n=331 [42%]). With median follow-up of approximately 32 mo in 1L-treated pts, the estimated rate of freedom from next-line therapy at 36 mo was similar between Black and White pts across all-treated pts and among Ibr-treated subgroups (Table). Estimated 36-mo OS rates in all-treated pts were also similar by race, with a high OS rate observed among Ibr-treated Black pts (97% at 36 mo). In multivariate analyses (MVA) in 1L-treated pts, male gender, poorer ECOG status, and increased comorbidity burden were independent predictors of decreased OS while race was not associated with OS. In 1L Ibr-treated pts, the only factor associated with decreased OS in MVA was longer time from diagnosis to 1L tx. Rates of serious AEs and AEs leading to tx discontinuation appeared similar across race (Table). Conclusions: Although historical retrospective studies from the pre-novel agent era have shown poorer clinical outcomes among Black pts with CLL relative to non-Black pts, results from informCLL show similar or potentially improved outcomes, including OS, among 1L Ibr-treated Black pts relative to White pts. These results suggest that access to novel agents such as Ibr may in part overcome historical disparities in clinical outcomes by race in pts with CLL. Clinical trial information: NCT02582879 . [Table: see text]
A matching-adjusted indirect comparison (MAIC) of the efficacy and safety of acalabrutinib (acala) versus zanubrutinib (zanu) in relapsed or refractory chronic lymphocytic leukemia (RR CLL).
Authors: Kittai Adam , Skarbnik Alan , Miranda Miguel , Yong Alan SM , Roos Jack , Hettle Robert , Palazuelos-Munoz Sarah , Shetty Vikram , Ghia Paolo 
Published: June 2023

7540 Background: The BTKi ibrutinib is the standard of care in RR CLL and was compared in head-to-head randomized clinical trials (RCTs) with second-generation BTKis: acala in ELEVATE-RR and zanu in ALPINE. However, major differences in these RCT's populations prevents comparison of acala and zanu. Acala was also assessed in the ASCEND RCT, which had a similar population to ALPINE but a different comparator. Thus, we used unanchored MAIC to compare the efficacy and safety of acala vs zanu using individual patient data (IPD) from ASCEND and published aggregate data from ALPINE. Methods: In the unanchored MAIC, acala IPD from ASCEND were weighted to match zanu baseline data from ALPINE. This reduced between-study differences in variables that were prognostic/effect-modifying of progression-free survival (PFS) in an exploratory multivariate cox regression analysis of ASCEND. These included sex, ECOG PS, bulky disease, prior chemoimmunotherapy, del(11q), del(17p), TP53 without del(17p), IGHV status, region, age, prior lines of therapy and Rai stage. An efficacy analysis assessed investigator-assessed PFS (INV PFS) in randomized patients with baseline data (acala, n = 149; zanu, n = 327). Pseudo IPD for INV PFS for zanu were obtained from Kaplan-Meier curves. A safety analysis assessed odds ratios (ORs) of AEs in treated patients with baseline data (acala, n = 148; zanu, n = 324). To allow comparison of the incidence of AEs, an artificial data cut-off (Feb 21, 2020) was imposed for acala to match the zanu median treatment exposure (both 28.4 months). Results: After matching, the effective sample size of acala was 99 (66.6%; 65% male; median age 66 years). 12- and 24-month INV PFS are shown below. The MAIC hazard ratio (HR) for INV PFS is similar for acala vs zanu (HR 0.90, 95% CI 0.60–1.36). The risk of having grade ≥ 3 AE (OR 0.66, 95% CI 0.41–1.05), atrial fibrillation (AF; OR 1.32, 95% CI 0.56–3.08), grade ≥ 3 AF/atrial flutter (OR 0.60, 95% CI 0.12–2.89), grade ≥ 3 hemorrhage (OR 0.61, 95% CI 0.19–2.03) or an AE leading to discontinuation (OR 1.14, 95% CI 0.61–2.13) was similar with acala vs zanu. The risk of having a serious AE (OR 0.61, 95% CI 0.39–0.97), hypertension (any grade: OR 0.18, 95% CI 0.09–0.37; grade ≥ 3: OR 0.22, 95% CI 0.09–0.54), any grade hemorrhage (OR 0.54, 95% CI 0.34–0.87) or an AE leading to dose reduction (OR 0.30, 95% CI 0.14–0.67) was lower with acala vs zanu. Conclusions: Acala and zanu have a similar efficacy in patients with RR CLL, while acala has a lower risk of grade ≥ 3 hemorrhage, any grade and grade ≥ 3 hypertension and dose reduction due to AEs vs zanu. Limitations of MAIC analyses mean the results should be viewed as hypothesis-generating. [Table: see text]
Utility of pharmacogenomic testing in predicting intolerance to BTK inhibitors.
Authors: Basher Fahmin , Scobie Micaela R , Kelley Michael J. , Voora Deepak , Friedman Daphne Ruth 
Published: June 2023

7541 Background: Oral inhibitors of Bruton’s tyrosine kinase (BTKi) are used for a number of B-cell malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and lymphoplasmacytic lymphoma (LPL). Real-world data has demonstrated that BTKi discontinuation is commonly due to intolerance, but contributing factors are not fully understood. Prior work suggests that cytochrome P450 (CYP) polymorphisms may increase the risk of targeted therapy discontinuation in CLL. We utilized pharmacogenomic (PGx) testing in Veterans treated with BTKi to evaluate the potential contribution of CYP polymorphisms to intolerance and responses to BTKi. Methods: We identified Veterans receiving care through the Veterans Administration (VA) who were prescribed a BTKi and underwent testing through the Pharmacogenomic Testing for Veterans (PHASER) program, currently offered at 22 VA facilities. We analyzed factors including time on BTKi therapy, reasons for discontinuation, and use of concomitant medications known to strongly inhibit CYP. Event-free survival (EFS) was defined as time from BTKi initiation to discontinuation. Results: Eighty-nine Veterans treated with BTKi who had PGx testing were identified, of which 97% (86) were male and 85% (76) were diagnosed with CLL. Other diagnoses included LPL (4), MCL (3), and MZL (3). Seventy-seven patients (pts) were treated with ibrutinib, nine with acalabrutinib and three with zanubrutinib. Three pts had poor metabolizer genotype (PMG) for CYP2C19 and 25 pts received strong CYP2C19 inhibitors (inh). Thirty-two pts had PMG for CYP2D6, and 12 pts received strong CYP2D6 inh. With a median follow up time of 38.9 months, 25 pts (28%) permanently discontinued due to intolerance and 10 pts (11%) progressed on BTKi therapy. Another 25 pts temporarily discontinued therapy. Median duration of BTKi therapy was 11.0 months for pts discontinuing for intolerance, 23.2 months for pts discontinuing for progression, and 38.5 months for pts not discontinuing therapy. Reasons for intolerance included arrhythmia, bleeding, and infections. EFS due to intolerance or progression was not statistically different between pts who were either CYP2C19 PMG or who received strong CYP2C19 inh, compared to all other pts. Interestingly, EFS due to intolerance alone was statistically different comparing these groups (p = 0.014, median 49.4m vs NR), but EFS due to progression was not (p = 0.76, median 79.6m vs NR). EFS was not significantly different comparing pts who were either receiving strong CYP2D6 inh or were PM to those who were not. Conclusions: We found that Veterans who were treated with BTKi and who either took concomitant strong CYP2C19 inh or had a CYP2C19 PMG were more likely to have intolerable side effects of BTKi therapy leading to discontinuation. Our results suggest that evaluating polypharmacy and PGx factors should be considered when prescribing BTKi.
Safety and efficacy of ABR in pts with TN or R/R MCL: Ph Ib trial.
Authors: Phillips Tycel Jovelle , Wang Michael , Robak Tadeusz , Gallinson David , Stevens Don A. , Patel Krish , Ramadan Safaa , Wun Chuan-Chuan , Jurczak Wojciech , Smith Stephen Douglas 
Published: June 2023

7546 Background: Acalabrutinib (A) is a next-generation Bruton tyrosine kinase inhibitor approved for relapsed/refractory (R/R) mantle cell lymphoma (MCL). Bendamustine (B) + rituximab (R) is used for treatment-naive (TN) and R/R MCL. We present updated data on safety and efficacy of ABR in patients (pts) with TN or R/R MCL. Methods: Eligible adults received ABR in this phase 1b study (NCT02717624) as follows: ABR for 6 28-d cycles, maintenance A+R for up to 2 y (TN cohort responders), then oral A continuously until progressive disease (PD) or treatment discontinuation due to toxicity (both cohorts). The primary endpoint was safety. Secondary endpoints were overall response rate (ORR), progression-free survival (PFS), and duration of response (DOR), all per Lugano. Results: Overall, 38 pts were enrolled (TN, n=18; R/R, n=20) with median age 66 y (range, 47–86). Baseline characteristics were (TN and R/R cohorts, respectively): stage IV disease in 88.9% and 95.0%, high-risk simplified MIPI score in 11.1% and 15.0%, bulky disease >5 cm in 16.7% and 30.0% or ≥10 cm in 5.6% and 10.0%, and blastoid morphology in 5.6% and 15.0%; R/R pts had a median of 2 prior lines of therapy. As of the data cutoff date (6/15/22), 6 (33.3%) TN pts and 4 (20.0%) R/R pts were receiving A monotherapy (Table). Most common any-grade AEs were nausea (n=14, 77.8%; TN) and neutropenia (n=11, 55.0%; R/R). Grade 3–4 AEs occurred in 13 (72.2%) TN pts and 17 (85.0%) R/R pts, most commonly neutropenia in both cohorts (n=7, 38.9% [TN]; n=10, 50.0% [R/R]). Serious AEs occurred in 11 (61.1%) TN pts and 13 (65.0%) R/R pts. There were no reports of ventricular tachyarrhythmia. Grade 3 atrial fibrillation occurred in 1 pt outside the safety reporting period and was not related to study treatment. Grade ≥3 major hemorrhage was reported in 2 (11.1%) TN pts and 3 (15.0%) R/R pts. Grade ≥3 hypertension was reported in 3 (16.7%) TN pts and 2 (10.0%) R/R pts. Five TN pts died (AE: pneumonitis, n=1; unknown, n=4) and 6 R/R pts died (AE: COVID and cerebrospinal meningitis, n=2; PD, n=2; unknown, n=2). ORR was 94.4% (n=17) in the TN cohort and 85.0% (n=17) in the R/R cohort, with CR rates of 77.8% (n=14) and 70.0% (n=14), respectively. Median DOR was not estimable (NE) in the TN cohort and 43.5 mo in the R/R cohort. Median PFS and overall survival were NE in the TN cohort (median follow-up 47.6 mo) and 28.6 mo and NE, respectively, in the R/R cohort (median follow-up 20.4 mo). Conclusions: Triple-combination ABR was tolerable and effective in pts with TN or R/R MCL. Clinical trial information: NCT02717624 . [Table: see text]
Real-world outcomes with novel therapies in R/R DLBCL.
Authors: Crombie Jennifer Leigh , Jun Monika P. , Wang Tongsheng , Mutebi Alex , Wang Anthony , Chibber Anindit , Kamalakar Rajesh , Ukropec Jon , Blædel Julie , Kalsekar Anupama 
Published: June 2023

7552 Background: Outcomes have historically been poor for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Despite an increase in approved R/R DLBCL treatment options, clinical outcomes of these therapies remain less certain. Novel treatments for R/R DLBCL patients include chimeric antigen receptor T-cell (CAR T) therapy, polatuzumab vedotin plus bendamustine and rituximab (pola-BR), tafasitamab plus lenalidomide (tafa-len), loncastuximab (lonca), and selinexor. The objective of this study was to examine real-world outcomes of these novel therapies. Methods: US patient data from the COTA electronic health records database (2010–2021) were used for this retrospective study. Patients had a diagnosis of DLBCL after 1/1/2010, with ≥1 prior line of systemic antineoplastic therapy (including an anti-CD20 antibody), and treatment with any of these novel therapies. Patients receiving variations of pola-BR or tafa-len regimens were included. Outcomes included overall response rate (ORR), complete response (CR) rate, median progression-free survival (mPFS), and median overall survival (mOS). Outcomes were also analyzed for those treated with any novel therapy following prior CAR T exposure. Results: A total of 175 R/R DLBCL patients were included (median age 63 y, 60.6% male, median of 2 prior therapies); 29.1% had an international prognostic index score ≥3, 61.7% had stage III/IV disease, and 65.7% had primary refractory disease. A total of 73, 69, and 27 patients were treated with CAR T, pola-BR, and tafa-len regimens, respectively. Only 6 patients were treated with lonca and no patients received selinexor. Among 169 patients treated in the 2L+ setting with tafa-len, pola-BR, and CAR T, the CR rate was 11.1%, 18.8%, and 52.1%, respectively (Table). A total of 112 patients were treated in the 3L+ setting with CR rate of 10.0%, 13.5%, and 41.8%, for tafa-len, pola-BR, and CAR T, respectively. Outcomes in the 18% of patients treated with any novel agent following CAR T exposure were ORR of 19.1%, CR of 4.8%, and mPFS and mOS of 1.4 mo and 2.3 mo, respectively. Conclusions: Outcomes of pola-BR and tafa-len regimens in the 2L+ and 3L+ R/R DLBCL setting remain suboptimal, with worse outcomes as patients advance through lines of therapy. Outcomes are particularly poor when these agents are used following CAR T therapy. [Table: see text]
Phase II trial of split-dose R-CHOP for older patients with diffuse large B-cell lymphoma (DLBCL).
Authors: Shah Nirav Niranjan , Szabo Aniko , Rajguru Saurabh , Devata Sumana , Howard Mitch , Pereira Deepa , Endres Mariah , Longo Walter L. , Hamadani Mehdi , Fenske Timothy S. , Fletcher Christopher David 
Published: June 2023

7554 Background: Management of elderly DLBCL is limited by age associated comorbid conditions and decreased tolerance of chemotherapy regimens. Many elderly or unfit/frail patients (pts) with DLBCL receive either non-anthracycline based treatment (tx) or attenuated regimens such as Rituximab (R)-miniCHOP which is ~50% dose reduction from standard R-CHOP-21. Split-dose (SD) R-CHOP is an alternative approach where pts receive CHOP at a 50% dose reduction on Days 1 and 15 of each 28-day cycle with full dose Rituximab on Day 1 for 6 cycles. The cumulative dose of SD R-CHOP delivered over each 28 day cycle is equivalent in dose intensity to one cycle of standard R-CHOP-21. Methods: This is a Phase II, prospective, open label study conducted through the Wisconsin Oncology Network and included two academic centers (NCT03943901). Older pts aged≥75 years or 70-74 years plus elevated cumulative illness rating scale for geriatrics score with untreated de-novo or transformed Stage IIX-IV DLBCL were eligible. Treatment consisted of two months (4 doses) of SD R-CHOP with growth factor support followed by interim response assessment with PET/CT and peripheral blood cell-free clonoSEQ minimal residual testing (MRD). Pts with interim PET/CT score of Deauville 1-3 and MRD negativity were offered abbreviated therapy with two additional months of SD-R-CHOP. All others completed 6 cycles. The primary endpoint was end of tx (EOT) complete response (CR) rate. We utilized a Simon 2-stage design with interim analysis requiring at least 8 EOT CR in the first 16 pts (Stage I) to proceed to stage II. Results: To date, 14 pts have completed tx. The median age was 81 years (73-88) and 57% (n = 8) were male. Most pts had stage 4 disease (n = 8, 57%). 8 of 14 pts were interim PET/CT negative and 8 of 12 MRD evaluable pts were interim MRD negative. 10/14 (71%) pts achieved EOT CR exceeding our minimal threshold to continue the study early. The remaining 4 pts had progressive disease (PD) either during tx or at EOT evaluation. 6 pts were both interim MRD and PET negative; 5 de-escalated to the abbreviated arm with all achieving CR with no relapses to date. 7 pts (50%) had Grade 3+ non-hematologic toxicities and 4 pts (29%) had Grade 3-4 neutropenia. There were 2 deaths, one from COVID-19 with concurrent PD and the other from PD. Median PFS or OS have not been reached with a median follow-up of 13 months for surviving pts. Conclusions: SD-R-CHOP offers older pts with DLBCL equivalent dose intensity as R-CHOP-21 through a fractionated dosing schedule improving tolerability. Prespecified interim efficacy endpoint was met early with 10/14 pts with EOT CR. Interim stratification by MRD and PET/CT allowed de-escalation of tx in early responding pts without compromising efficacy. Clinical trial information: NCT03943901 . [Table: see text]
Long-term efficacy and safety of pembrolizumab with R-CHOP as first-line therapy for DLBCL.
Authors: Ho Carrie , Fromm Jonathan R. , Fang Min , Till Brian G. , Shadman Mazyar , Cowan Andrew , Lynch Ryan C. , Wu Vicky , Voutsinas Jenna M. , Rasmussen Heather A. , Blue Katharine , Ujjani Chaitra Shankar , Shustov Andrei R. , Cassaday Ryan Daniel , Gopal Ajay K. , Smith Stephen Douglas 
Published: June 2023

7561 Background: Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) represents the historical 1st line treatment standard for DLBCL but fails to cure about 1/3 of patients. While generally ineffective in relapsed DLBCL-NOS, checkpoint inhibitors may have greater promise in untreated, immunocompetent patients. We previously reported safety and early efficacy of pembrolizumab plus RCHOP, noting objective responses in 90% of patients (CR 77%) and a 2-year progression-free survival (PFS) of 83%. We now report 5 year follow up of our study. Methods: Patients age > 18 with untreated DLBCL or grade 3b follicular lymphoma, intended to receive 6 cycles of R-CHOP, were eligible. Pembrolizumab 200 mg IV with R-CHOP was given in 21-day cycles for 6 cycles. For this updated analysis, progression and survival events, and immune-related toxicities, are reported. Additionally, prognostic factors including tumor PD-L1 expression (Qualtek/Merck) were re-analyzed. Results: 30 patients were treated (13/30 with IPI 3-5). Median follow up is now 4.8 years (95% CI, 4.5-5.4). Since our initial report (Smith BJH 2019) we have observed 1 additional relapse (alive after CAR-T therapy) and 2 deaths in remission (1 urothelial carcinoma, 1 respiratory failure in the setting of progressive ILD). 5-year PFS is 71% (CI, 54-94%) and 5-year overall survival 83% (CI, 71-98%). During the study period and at long term follow up, there were 8 total immune-related adverse events (IRAEs) among 7 patients (23%) (Table). Four were treatment-emergent AE (occurred within 90 days of completing treatment): grade 1 hyperthyroidism, grade 2 hyperthyroidism, grade 3 pneumonitis, and grade 3 rash. There were 4 late IRAEs: colitis, paraneoplastic pemphigus, rheumatoid arthritis, and Graves’ disease, occurring at 3, 5, 8, and 46 months after completing treatment, respectively. PD-L1 tumor expression was documented in 19 of 23 (83%) tested patients. At long-term follow up, none of the 19 patients who had any PD-L1 expression have relapsed. Two out of the 4 patients with no PD-L1 expression have relapsed. On univariate analysis, PD-L1 H-score >0 (p<0.0001) was associated with improved PFS. Conclusions: At 5 year follow-up, pembrolizumab plus R-CHOP has led to durable responses in most patients with the best outcomes in PDL1-expressing disease. Furthermore, the safety profile was manageable, with a low rate of grade 3 or higher IRAEs (10%) and no consistent pattern of late events. These data support ongoing strategies incorporating PD-1/PDL-1 inhibitors in 1st line DLBCL therapy and confirmation of predictive biomarkers including tumor PD-L1 expression. Clinical trial information: NCT02541565 . [Table: see text]
A multi-institutional prospective cohort study of minimal residual disease in peripheral T-cell lymphoma: Impact of autologous stem cell transplant.
Authors: Foley Nicole C. , Russler-Germain David , Watkins Marcus , Jacobsen Eric D. , Moskowitz Alison J. , Cashen Amanda F. , Fehniger Todd A. , Kahl Brad S. , Ghobadi Armin , Reagan Beth , Fischer Anne , Wan Fei , Jacobsen Austin , Elias Karina , Holman Matt , Hill Natalie , Gordon Skyler , Huang Ying , Horwitz Steven M. , Mehta-Shah Neha 
Published: June 2023

7563 Background: Roughly 80% of pts with peripheral T-cell lymphomas (PTCL) respond to CHOP-based therapy but 5-yr survival ranges between 20-40%. The high relapse rate after complete response (CR) suggests more sensitive response assessment, such as minimal residual disease (MRD) testing, could have prognostic or predictive value. Next generation sequencing (NGS) of the T-cell receptor (TCR) can detect a known TCR clonotype at 10-5. In a prospective study, we evaluated the utility of MRD testing via TCR NGS in PTCL (NCT03297697). Here we report results for pts pre- and post-autologous stem cell transplant (ASCT). Methods: This investigator-initiated, multi-institutional, prospective cohort study assessed MRD testing by TCR NGS in PTCL. Pts with previously untreated PTCL not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), PTCL with T-follicular helper (TFH) phenotype, or monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL) treated with anthracycline-based curative-intent therapy were eligible. Baseline TCR (TRG or TRB) clonotypes were established from diagnostic tissue or peripheral blood if tissue was not available. TCR clonality was determined positive via the LymphoTrack TRG/TRB Assays – MiSeq (Invivoscribe, San Diego, CA) when top % reads were ≥2.5% and ≥2x above background. Samples were obtained at diagnosis (pre-treatment), following induction therapy (EOT/pre-ASCT), and serially post-ASCT. Results: Of 43 enrolled pts, 19 underwent consolidative ASCT, of which 10 had post-ASCT samples available for MRD testing (Table). Median age at ASCT was 62 years (range: 38-77). Baseline TCR clonotypes were identified in 10/10 pts. At pre-ASCT evaluation, 7/10 pts had detectable TCR MRD (‘pos’) and 3/10 pts had TCR MRD below the level of detection (‘neg‘). Of the 3 MRD neg pts pre-ASCT, 2 had CR and 1 had PR by PET-CT. All 7 TCR MRD pos pts pre-ASCT had CR by PET-CT. Of 7 MRD pos pts pre-ASCT, 6 remained MRD pos and 1 became MRD neg post-ASCT. Of the 4 MRD neg pts post-ASCT, none have relapsed at 52, 31, 34, and 31 mo post-ASCT. Of 7 MRD pos pts pre-ASCT, 3 have relapsed following ASCT (at 3, 9, and 29 mo post-ASCT). Conclusions: In this cohort of patients with PTCL receiving consolidative ASCT in CR1, all 4 pts with negative TCR MRD post-ASCT remain in remission at median follow up of 32.5 mo post-ASCT. The negative predictive value of TCR NGS MRD post-ASCT should be further evaluated. Clinical trial information: NCT03297697 . [Table: see text]