A Phase 1 interventional study of voruciclib monotherapy and voruciclib and venetoclax in Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL) and Marginal Zone Lymphoma (MZL), sponsored by MEI Pharma, Inc.. Terminated at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by MEI Pharma, Inc. · Phase 1, Interventional, and Treatment
This is a Phase 1, open-label, dose escalation study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML
This is a Phase 1, open-label, 3 + 3 dose escalation and expansion study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of prior standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML. Escalation to the next higher dose level will depend on demonstrated safety and tolerability at each dose level.
931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.
This study's enrollment of 84 is above the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →MEI Pharma, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Histologically-confirmed diagnosis of Follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia(CLL), diffuse large B-cell lymphoma (DLBCL), or AML
a. Subjects must have disease that has relapsed or is refractory to 2 or more prior regimens and in need of treatment due to progressive disease
Exclusion Criteria:
For AML subjects:
Ongoing immunosuppressive treatment including calcineurin inhibitors at the time of the start of study treatment, including systemic or enteric corticosteroids except as follows:
voruciclib monotherapy - Open-label, 3 + 3 dose escalation study which may enroll up to 6 subjects at each dose level and disease type (AML or B-cell malignancies) voruciclib and venetoclax - Open-label, 3 + 3 dose escalation study which may enroll up to 6 subjects at each dose level for AML subjects
Drug: voruciclib monotherapy · Drug: voruciclib and venetoclax
Voruciclib will be administered orally
Also known as: ME-522
Voruciclib and Venetoclax will be administered orally
Also known as: VENCLEXTA®, ME-522
Determine the safety and tolerability of voruciclib
Safety will be measured by the incidence of all AEs and SAEs, timing, grade \[CTCAE v4.03\] severity, seriousness, relatedness. Tolerability will be measured by the incidence of DLTs (dose limiting toxicities)
Time frame: 2 years
Determine the safety and tolerability of voruciclib in combination with venetoclax in subjects with AML.
Safety will be measured by the incidence of all AEs and SAEs, timing, grade \[CTCAE v4.03\] severity, seriousness, relatedness. Tolerability will be measured by the incidence of DLTs (dose limiting toxicities)
Time frame: 2 years
Overall Response Rate (ORR)
defined as the sum of complete response (CR), complete remission with incomplete marrow recovery (CRi) and partial response (PR) for B-cell malignancies, or for AML the sum of CR/CRi rate by the 2017 European LeukemiaNet (ELN) criteria
Time frame: 2 years
Duration of Response (DOR)
defined as the time from the initial determination of response to the time of disease progression or death on study, which ever occurs first
Time frame: 2 years
Progression Free Survival (PFS)
defined as the time from the first dose of study drug administration (Cycle 1 Day 1) to disease recurrence or progression as defined by IWG criteria, or death on study
Time frame: 2 years
Evaluate the PK of voruciclib
Determined by the Area Under the Concentration time curve (AUC)
Time frame: 2 years
Evaluate the PK of voruciclib Cmax in combination with venetoclax Determined by the Area Under the Concentration time curve (AUC)
Determined by the Area Under the Concentration time curve (AUC)
Time frame: 2 years
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
MEI Pharma, Inc.