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Follicular Lymphoma (FL)Phase 1NCT03547115

A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML

A Phase 1 study testing voruciclib monotherapy and voruciclib and venetoclax in people with Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL), run by MEI Pharma, Inc. at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
voruciclib monotherapy and voruciclib and venetoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
12 sitesUnited States
Study dates
31 May 2018to 24 Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • 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
  • 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
  • Presence of measurable disease defined per the 2008 International workshop on CLL guidelines, or by 2014 Lugano criteria for non-Hodgkin lymphoma (does not apply for AML subjects)
  • Adequate hematologic parameters unless clearly due to the disease under study
  • Adequate renal and hepatic function, per laboratory reference range at screening

Who cannot join

  • History of pneumonitis of any cause
  • For CLL subjects: only known histological transformation to an aggressive lymphoma
  • For AML subjects:
  • Acute promyelocytic leukemia
  • Peripheral blast count > 25 × 10 9/L
  • Known central nervous system involvement
Show all 17Show fewer
  • Significant cardiovascular disease
  • Significant screening ECG abnormalities
  • Subjects who require warfarin, anti-cancer therapeutics or investigational agents
  • Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the time of start of voruciclib therapy
  • Prior solid organ transplantation
  • Receipt of an allogeneic transplant within 6 months or an autologous transplant within the preceding 3 months; evidence of ongoing graft-versus-host disease (GVHD)
  • Prior therapy with a cyclin-dependent kinase (CDK9) inhibitor
  • Symptomatic/uncontrolled HIV infection/AIDS, or currently taking contraindicated medications for HIV control
  • Ongoing immunosuppressive treatment including calcineurin inhibitors at the time of the start of study treatment, including systemic or enteric corticosteroids except as follows:
  • Prior to the start of study treatment, subjects may be using systemic corticosteroids (≤20 mg/day of prednisone or equivalent), topical, or inhaled corticosteroids
  • During study therapy, subjects may use systemic, topical, or enteric corticosteroids, if needed

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • City of Hope

    Duarte, California, 91010

  • Duke University

    Durham, North Carolina, 27705

  • MD Anderson

    Houston, Texas, 77030

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • New York University

    New York, New York, 10016

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Swedish Cancer Institute

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Phase 1, Open-label, Study of Voruciclib in Subjects With Relapsed and/or Refractory B Cell Malignancies or AML After Failure of Prior Standard Therapies and Voruciclib in Combination With Venetoclax in Subjects With Relapsed/Refractory AML

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

Read the detailed description

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.

Being tested
voruciclib monotherapy, voruciclib and venetoclax
Keywords
B-Cell Malignancies, AML, voruciclib, venetoclax
Medical subject headings
Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • voruciclib monotherapyDrug

    Also called ME-522

    Voruciclib will be administered orally

  • voruciclib and venetoclaxDrug

    Also called VENCLEXTA®, ME-522

    Voruciclib and Venetoclax will be administered orally

Study groups in NCT03547115
Study groupRoleWhat they receive
voruciclib monotherapy and voruciclib in combination with venetoclaxExperimentalvoruciclib 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
Receives: Drug: voruciclib monotherapy; Drug: voruciclib and venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 2 years

  2. 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)

    Measured: 2 years

Secondary outcomes (5)

  1. 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

    Measured: 2 years

  2. 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

    Measured: 2 years

  3. 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

    Measured: 2 years

  4. Evaluate the PK of voruciclib

    Determined by the Area Under the Concentration time curve (AUC)

    Measured: 2 years

  5. 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)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2018
  2. Study start31 May 2018
  3. Primary completion24 Jul 2024
  4. Study completion24 Jul 2024

Why it stopped: Business reasons, not related to safety or efficacy results.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a Phase 1, open-label, 3 + 3 dose escalation study to determine the safety and preliminary efficacy of voruciclib alone or in combination with venetoclax.
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03547115
Sponsor's protocol ID
ME-522-001
Status last verified
Mar 2026
First submitted
24 May 2018
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Alvarado-Valero Y, Cook RJ, Dinner SN, Keng M, Begna KH, Javidi-Sharifi N, Abedin S, Al Malki MM, Bhatt VR, Rajagopalan P, Tang M, Wiley SE, Ghalie RG, Davids MS. The oral CDK9 inhibitor voruciclib combined with venetoclax for patients with relapsed/refractory acute myeloid leukemia. Blood Neoplasia. 2025 Apr 25;2(3):100108. doi: 10.1016/j.bneo.2025.100108. eCollection 2025 Aug.

    PubMed 40809193

  • Davids MS, Brander DM, Alvarado-Valero Y, Diefenbach CS, Egan DN, Dinner SN, Javidi-Sharifi N, Al Malki MM, Begna KH, Bhatt VR, Abedin S, Cook RJ, Collins MC, Roleder C, Dominguez EC, Rajagopalan P, Wiley SE, Ghalie RG, Danilov AV. A phase 1 study of the CDK9 inhibitor voruciclib in relapsed/refractory acute myeloid leukemia and B-cell malignancies. Blood Adv. 2025 Feb 25;9(4):820-832. doi: 10.1182/bloodadvances.2024014633.

    PubMed 39705540

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing voruciclib monotherapy and voruciclib and venetoclax in people with Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL), run by MEI Pharma, Inc. at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business reasons, not related to safety or efficacy results.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the safety and tolerability of voruciclib (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03547115, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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