ME-401

DRUG4 trials

Sponsors

MEI Pharma, Inc., Kyowa Kirin Co., Ltd., Deepa Jagadeesh

Conditions

Chronic Lymphocytic Leukemia (CLL)Diffuse Large B-Cell LymphomaDiffuse Large B-cell Lymphoma (DLBCL)Follicular Lymphoma (FL)High Grade Non-Hodgkin's LymphomaIndolent B-cell Non-Hodgkin's LymphomaMantle Cell Lymphoma (MCL)Marginal Zone B Cell Lymphoma

Phase 1

A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma

TerminatedNCT02914938

MEI Pharma, Inc.Chronic Lymphocytic Leukemia (CLL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL) +4

Start: 2016-10-31End: 2023-03-29Updated: 2023-05-09

Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

CompletedNCT03985189

Kyowa Kirin Co., Ltd.Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Start: 2019-04-29End: 2025-01-15Updated: 2025-12-19

ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma

TerminatedNCT04517435

Deepa JagadeeshDiffuse Large B-Cell Lymphoma

Start: 2021-04-28End: 2023-05-17Updated: 2025-02-07

Phase 2

Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)

Active, not recruitingNCT04533581

Kyowa Kirin Co., Ltd.Indolent B-cell Non-Hodgkin's Lymphoma

Start: 2020-09-17End: 2028-05-31Updated: 2025-09-11

Related Papers

A phase <scp>II</scp> study of zandelisib in patients with relapsed or refractory indolent non‐Hodgkin lymphoma: <scp>ME</scp>‐401‐<scp>K02</scp> study

British Journal of Haematology2025-01-085 citations

Safety and efficacy of zandelisib plus zanubrutinib in previously treated follicular and mantle cell lymphomas

British Journal of Haematology2024-03-194 citations

Safety Results of a Phase I Study of Zandelisib + R-CHOP in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL)

Blood2023-11-02

P1086: EFFICACY AND SAFETY OF ZANDELISIB ADMINISTERED BY INTERMITTENT DOSING IN JAPANESE PATIENTS WITH RELAPSED/REFRACTORY INDOLENT B-CELL NON-HODGKIN’S LYMPHOMA: PRIMARY ANALYSIS OF THE PHASE 2 STUDY MIRAGE

HemaSphere2023-08-01

Zandelisib (ME-401) in Japanese patients with relapsed or refractory indolent non-Hodgkin’s lymphoma: an open-label, multicenter, dose-escalation phase 1 study

International Journal of Hematology2022-09-1512 citations

Zandelisib with continuous or intermittent dosing as monotherapy or in combination with rituximab in patients with relapsed or refractory B-cell malignancy: a multicentre, first-in-patient, dose-escalation and dose-expansion, phase 1b trial.

2022-07-1121 citations

P1114: ZANDELISIB ON INTERMITTENT DOSING AS A SINGLE AGENT OR IN COMBINATION WITH RITUXIMAB OR ZANUBRUTINIB IN RELAPSED/REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL): RESULTS FROM A MULTI-ARM PHASE 1B STUDY

HemaSphere2022-06-01

ZANDELISIB, A PI3Kδ INHIBITOR ON INTERMITTENT SCHEDULE (IS) IN FOLLICULAR LYMPHOMA PATIENTS WHO PROGRESSED WITHIN 24 MONTHS OF FIRST‐LINE CHEMOIMUNOTHERAPY (POD24)

Hematological Oncology2021-06-01

Efficacy and safety of the PI3Kδ inhibitor zandelisib (ME-401) on an intermittent schedule (IS) in patients with relapsed/refractory follicular lymphoma (FL) with progression of disease within 24 months of first-line chemoimmunotherapy (POD24).

Journal of Clinical Oncology2021-05-205 citations

Initial results of the combination of PI3Kδ inhibitor zandelisib (ME-401) and the BTK inhibitor zanubrutinib in patients (pts) with relapsed or refractory (R/R) B-cell malignancies.

Journal of Clinical Oncology2021-05-201 citations

Tolerability and durable respones of the PI3Kδ inhibitor ME-401 administered on an intermittent schedule in relapsed/refractory (R/R) follicular lymphoma (FL) and other B-cell malignancies.

Journal of Clinical Oncology2020-05-2010 citations

INVESTIGATING SAFETY AND PRELIMINARY EFFICACY OF AFM13 PLUS PEMBROLIZUMAB IN PATIENTS WITH RELAPSED/REFRACTORY HODGKIN LYMPHOMA AFTER BRENTUXIMAB VEDOTIN FAILURE

Hematological Oncology2019-06-0110 citations

THE PI3Kδ INHIBITOR ME‐401 ± RITUXIMAB IN RELAPSED/REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL), CHRONIC LYMPHOCYTIC LEUKEMIA (CLL), AND SMALL LYMPHOCYTIC LYMPHOMA (SLL)

Hematological Oncology2019-06-015 citations

Results of the PI3Kδ inhibitor ME-401 alone or with rituximab in relapsed/refractory (R/R) follicular lymphoma (FL).

Journal of Clinical Oncology2019-05-2012 citations

Initial results of a dose escalation study of a selective and structurally differentiated PI3Kδ inhibitor, ME-401, in relapsed/refractory (R/R) follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Journal of Clinical Oncology2018-05-2018 citations