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Experimental drug voruciclib tested in desperate blood cancer patients

NCT ID NCT03547115

Disease control Sponsor: MEI Pharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested an experimental drug called voruciclib, either alone or combined with another drug (venetoclax), in adults with several types of blood cancers (like lymphoma, leukemia) that had come back or stopped responding to prior treatments. The main goal was to check safety and find the right dose. The study was terminated early, so full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
voruciclib (alone or with venetoclax)
What this could lead to
If it works, this could point toward a new treatment option for people with blood cancers that have stopped responding to standard therapies.
What could go wrong
This is a very early Phase 1 trial focused on safety, not proof of effectiveness. The trial was terminated early, so results may be limited. Side effects and lack of benefit are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

84 people

The number who actually took part.

Started

May 2018

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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 * 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 Exclusion Criteria: * History of pneumonitis of any cause * For CLL subjects: only known histological transformation to an aggressive lymphoma * For AML subjects: 1. Acute promyelocytic leukemia 2. Peripheral blast count \> 25 × 10 9/L * Known central nervous system involvement * 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: 1. Prior to the start of study treatment, subjects may be using systemic corticosteroids (≤20 mg/day of prednisone or equivalent), topical, or inhaled corticosteroids 2. During study therapy, subjects may use systemic, topical, or enteric corticosteroids, if needed

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia B-cell chronic lymphocytic leukemia diffuse large B-cell lymphoma follicular lymphoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia (AML) Chronic lymphocytic leukemia, CLL Diffuse large B-cell lymphoma (DLBCL) Follicular lymphoma ( FL) Mantle cell lymphoma (MCL) Marginal zone lymphoma (MZL) Small lymphocytic lymphoma (SLL)

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • MD Anderson

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • New York University

    New York, New York, 10016, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

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