Phase 2 study of the safety and efficacy of INCB050465 in patients with relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) (CITADEL-202).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS7579-TPS7579 ◽  
Author(s):  
Morton Coleman ◽  
Andres Forero-Torres ◽  
Vincent Ribrag ◽  
Ian Chau ◽  
Douglas James DeMarini ◽  
...  
Keyword(s):  
B Cell ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Phase 2 ◽  
Large B Cell Lymphoma ◽  
Phase 2 Study ◽  
Group A ◽  
Btk Inhibitor ◽  
Group B ◽  
Large B Cell

TPS7579 Background: Aberrant activation of PI3Kδ is implicated in B-cell malignancies. INCB050465, a highly selective PI3Kδ inhibitor, is demonstrating preliminary efficacy in an ongoing phase 1/2 dose-escalation and expansion study as monotherapy for r/r DLBCL as well as for other r/r B-cell malignancies (ASH 2016; Abstract 4195). This phase 2 study will further evaluate the efficacy and safety of single-agent INCB050465 in pts with r/r DLBCL. Methods: In this phase 2, multicenter, open-label study (NCT02998476), eligible adults will have r/r DLBCL diagnosis, defined as receiving 1–5 prior treatments and be ineligible for high-dose chemotherapy or autologous stem-cell transplant (SCT). Pts will also have ≥1 measurable lesion (nodal ≥2 cm or extranodal > 1 cm in longest dimension); Eastern Cooperative Oncology Group performance status ≤2; adequate hematologic, hepatic, and renal function; no mediastinal large B-cell lymphoma or CNS metastases; no allogeneic SCT ≤6 months, or graft-versus-host-disease after allogeneic SCT, or autologous SCT ≤3 months, before first dose; and no prior treatment with PI3K inhibitors. Pts will be enrolled into 2 groups according to prior treatment with a Bruton’s tyrosine kinase (BTK) inhibitor (Group A [n = 100, no BTK inhibitor] or B [n≤20, received BTK inhibitor]). Both groups will receive INCB050465 20 mg orally QD for 8 wks; then 20 mg QW until disease progression, death, unacceptable toxicity, or consent withdrawal. The primary endpoint is the objective response rate in Group A (complete/partial response per independent review committee based on Lugano criteria). Secondary endpoints will include duration of response, progression-free survival, overall survival, and safety in Group A (these endpoints will be exploratory in Group B). Other exploratory assessments will include pharmacokinetics and association between genetic characteristics and treatment response in both groups. In a planned interim futility analysis of Group A, the study will be terminated if ≤13 of the first 40 treated pts respond (no futility analysis of Group B will be conducted). The study is currently recruiting (estimated completion date, March 2020). Clinical trial information: NCT02998476.

Phase 2 Study of Dose-Reduced Consolidation Radiation Therapy in Diffuse Large B-Cell Lymphoma

2019 ◽  
Vol 105 (1) ◽  
pp. 96-101 ◽  
Author(s):  
Chris R. Kelsey ◽  
Gloria Broadwater ◽  
Olga James ◽  
Junzo Chino ◽  
Louis Diehl ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
B Cell ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Phase 2 ◽  
Large B Cell Lymphoma ◽  
Phase 2 Study ◽  
Large B Cell

Surgical Resection and Rituximab Show No Benefit in the Treatment of Primary Gastric Diffuse Large B-Cell Lymphoma

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5110-5110
Author(s):  
Haiwen Huang ◽  
Tianwen Fu ◽  
Qiangli Wang ◽  
Ting Xu ◽  
Xiaochen Chen ◽  
...  
Keyword(s):  
Lactate Dehydrogenase ◽  
B Cell ◽  
Surgical Resection ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Chemotherapy Group ◽  
Large B Cell Lymphoma ◽  
Group A ◽  
Group B ◽  
Large B Cell

Abstract Objectives Clinically, primary gastric diffuse large B cell lymphoma (PG-DLBCL) is not encountered commonly. The optimal treatment of PG-DLBCL remains controversial. Whether patients should receive surgical resection, Rituximab or not was most concerned about. Here we analized 83 patients with PG-DLBCL retrospectivly and evaluated the effect of surgical option and Rituximab in the treatment of PG-DLBCL. Methods From January 2009 to December 2014, 83 cases of PG-DLBCL patients in the First Affiliated Hospital of Soochow University were retrospectively studied. Forty cases received surgical resection plus chemotherapy (group A) and 43 patients underwent chemotherapy alone (group B). The operation mode is decided by the surgeon according to the patients¡¯ current condition and the chemotherapy regimens of two groups were CHOP or R-CHOP. Patients¡¯ characteristics were listed in Table 1. The main outcomes of overall survival (OS) and the progression free survival (PFS) were analized by using the Kaplan-Meier (K-M) method. Results The K-M analysis showed that the 3-year PFS and OS in group A were 66.7% and 68.4%, respectively. On the other hand, the 3-year PFS and OS of group B were 82.6%and 85.7%, respectively. There is no significant difference between the two groups. For patients received CHOP or R-CHOP, the 5-year OS were 77.7% and 78.2% (p=0.178). And the 3-year PFS were 74.9% and 75.5% (p=0.347). The difference between the two groups was not statistically significant. In group A, the 5-year PFS of R-CHOP group and CHOP group is 62.5% and 71.2% £¨p=0.747£©, the 5-year OS of R-CHOP group and CHOP group is 64.2% and 73.6% (p=0.853). In group B, the 5-year PFS of R-CHOP group and CHOP group is 83.4% and 81.8% £¨p=0.706£©, the 5-year OS of R-CHOP group and CHOP group is 85.7% and 83.5% (p=0.753). The univariate analyses indicated that age and lactate dehydrogenase (LDH) level were related to prognosis. Multivariate analysis of prognostic factors with a Cox model showed that IPI was the only independent prognostic factor. Conclusions This study shows that PG-DLBCL patients have a similar long-term survival rate when adopted surgery plus chemotherapy. Therefore, resection of the primary tumor before systemic chemotherapy does not improve the survival of the patients with PG-DLBCL. At the same time, the addition of Rituximab to chemotherapy doesn¡¯t make difference for the survival of PG-DLBCL. More prospective clinical trials about the effect of surgical operation and rituximab are needed to confirm the results of our study. Table 1. Patients¡¯ baseline characteristics Patients £¨%£© P value With surgical resection(Group A, n£½40£© Without chemotherapy (Group B, n £½ 43 £© Gender Male 19£¨47.5%£© 24£¨55.8%£© 0.449 Female 21£¨52.5%£© 19£¨44.2%£© Age ¡Ü60 15£¨37.5%£© 22£¨51.2%£© 0.211 £¾60 25£¨62.5%£© 21£¨48.8%£© Ann Arbor Stage I/II 13£¨32.5%£© 7£¨16.3%£© 0.084 Stage III/IV 27£¨67.5%£© 36£¨83.7%£© ECOG £¼2 19£¨47.5%£© 22£¨51.2%£© 0.739 ¡Ý2 21£¨52.5%£© 21£¨48.8%£© Treatment plan R-CHOP 23£¨57.5%£© 24£¨55.8%£© 0.887 CHOP 17£¨42.5%£© 19£¨44.2%£© LDH ¡Ü245 24£¨60.0%£© 27£¨62.8%£© 0.794 £¾245 16£¨40.0%£© 16£¨37.2%£© IPI ¡Ü2 13£¨32.5%£© 15£¨34.9%£© 0.818 £¾2 27£¨67.5%£© 28£¨65.1%£© ECOG: Eastern Cooperative Oncology Group; CHOP: cyclophosphamide, doxorubicin, vincristine, prednisone; R-CHOP: rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone; LDH: lactate dehydrogenase Disclosures No relevant conflicts of interest to declare.

A phase 2 study of PNT2258 in patients with relapsed or refractory (r/r) diffuse large b-cell lymphoma (DLBCL): An initial report from the Wolverine study.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. TPS7577-TPS7577 ◽  
Author(s):  
Jason R. Westin ◽  
Michael B. Maris ◽  
Ayad M. Al-Katib ◽  
Nehal J. Lakhani ◽  
Prapti Arvind Patel ◽  
...  
Keyword(s):  
B Cell ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Phase 2 ◽  
Initial Report ◽  
Large B Cell Lymphoma ◽  
Phase 2 Study ◽  
Large B Cell

Outcomes by prior lines of therapy (LoT) in ZUMA-1, the pivotal phase 2 study of axicabtagene ciloleucel (Axi-Cel) in patients (Pts) with refractory large B cell lymphoma.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 3039-3039 ◽  
Author(s):  
Frederick Lundry Locke ◽  
Armin Ghobadi ◽  
Lazaros J. Lekakis ◽  
David Bernard Miklos ◽  
Caron A. Jacobson ◽  
...  
Keyword(s):  
B Cell ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Phase 2 ◽  
Pivotal Phase ◽  
Large B Cell Lymphoma ◽  
Phase 2 Study ◽  
Large B Cell

Phase 2 study of parsaclisib (INCB050465) for relapsed or refractory diffuse large b-cell lymphoma (DLBCL) (CITADEL-202).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e19038-e19038 ◽  
Author(s):  
Morton Coleman ◽  
David Belada ◽  
René-Olivier Casasnovas ◽  
Rémy Gressin ◽  
Hui-Peng Lee ◽  
...  
Keyword(s):  
B Cell ◽  
Phase 1 ◽  
B Cell Lymphoma ◽  
Phase 2 ◽  
Non Hodgkin Lymphoma ◽  
Phase 2 Study ◽  
Group A ◽  
Btk Inhibitor ◽  
Group B ◽  
General Physical

e19038 Background: Parsaclisib, a potent, highly selective, next-generation PI3Kδ inhibitor, showed preliminary efficacy as monotherapy for relapsed or refractory non-Hodgkin lymphoma, including DLBCL (Abstract 410, ASH 2017), in a phase 1/2 study. This phase 2 study further assessed parsaclisib in patients (pts) with relapsed or refractory DLBCL (NCT02998476). Methods: Pts enrolled into 2 groups (A, Bruton tyrosine kinase [BTK] inhibitor naïve; B, BTK inhibitor experienced) and received oral parsaclisib 20 mg QD for 8 wks, then 20 mg QW. In a planned interim futility analysis conducted in the first 40 pts treated in Group A, if ≤13 (≤32.5%) responded by IRC assessment, Group A was to be terminated. Results: At data cutoff (22 Jun 2018), 60 pts (Group A, n = 55; Group B, n = 5) were treated (median age, 71 y [range, 36—94]; men, 63.3%; ≥3 prior systemic therapies, 60%). At the planned interim analysis in Group A, ORR (by PET) was 25% (10/40 pts; 5 CMR, 5 PMR); the futility boundary was crossed. At data cutoff, ORR in Group A was 25.5% (14/55 pts; 8 CMR, 6 PMR); median PFS was 2.2 mo (95% CI: 2.0‒4.1); median DOR was 4.5 mo (95% CI: 2.1‒5.1). ORs were observed in germinal center B-cell (GCB) and non-GCB subtypes. ORR in Group B was 20% (1/5 pts; 1 CMR). The most common non-hematologic treatment-emergent adverse events (TEAEs) occurring in > 10% of all pts (all grade [Gr]; Gr 3/4) were rash events (21.7%; 1.7%), colitis/diarrhea events (16.7%; 5%), nausea (16.7%; 0%), cough (15%; 0%), and pyrexia (15%; 8.3%). Gr 3/4 AST and ALT elevations occurred in 5% and 1.7% of pts, respectively; Gr 3/4 neutropenia and anemia occurred in 5% of pts each. The most frequent ( > 5%) serious TEAEs were pyrexia (8.3%), general physical health deterioration (6.7%), and hypercalcemia (6.7%). TEAEs led to therapy discontinuation in 7 pts (2 treatment-related), dose interruption in 20 pts (10 treatment-related), and dose reduction in 3 pts (all treatment-related). Median duration of therapy was 57.5 d (range, 11–318). Conclusions: Parsaclisib monotherapy using a QD followed by QW dosing regimen was well tolerated with no new safety signals reported. Further evaluation of parsaclisib in all subtypes of DLBCL is ongoing in a combination study Clinical trial information: NCT02998476.

scholarly journals Phase 2 study of CHOP-R-14 followed by 90Y-ibritumomab tiuxetan in patients with previously untreated diffuse large B-cell lymphoma

2017 ◽  
Vol 6 (4) ◽  
pp. 627-633 ◽  
Author(s):  
Reem Karmali ◽  
Melissa L. Larson ◽  
Jamile M. Shammo ◽  
Stephanie A. Gregory ◽  
Teresa O'Brien ◽  
...  
Keyword(s):  
B Cell ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Phase 2 ◽  
Ibritumomab Tiuxetan ◽  
Large B Cell Lymphoma ◽  
Phase 2 Study ◽  
Large B Cell
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