100 Participants Needed

Voruciclib + Venetoclax for Leukemia and Lymphoma

Recruiting at 11 trial locations
MP
Overseen ByMEI Pharma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, like warfarin, anti-cancer drugs, or investigational agents. If you're on immunosuppressive treatments or certain medications for HIV, you may also need to stop those before starting the trial.

Is the combination of Voruciclib and Venetoclax safe for treating leukemia and lymphoma?

Venetoclax has been shown to have an acceptable safety profile in treating chronic lymphocytic leukemia (CLL) and other blood cancers, with common side effects including nausea, diarrhea, and low blood cell counts. These side effects are generally manageable with supportive care and dose adjustments.12345

What makes the drug combination of Voruciclib and Venetoclax unique for treating leukemia and lymphoma?

The combination of Voruciclib and Venetoclax is unique because Venetoclax is a first-in-class, oral drug that specifically targets and inhibits B-cell lymphoma 2 (BCL-2), a protein that helps cancer cells survive. This combination may offer a novel approach by potentially enhancing the effectiveness of Venetoclax in treating leukemia and lymphoma, especially in cases where other treatments have failed.24567

What data supports the effectiveness of the drug Venetoclax for leukemia and lymphoma?

Venetoclax has shown to be effective in treating chronic lymphocytic leukemia (CLL), achieving response rates of about 80% in patients with relapsed or refractory CLL. It has also been effective in combination therapies, providing longer progression-free survival and higher rates of undetectable minimal residual disease compared to other treatments.23457

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain B-cell malignancies or AML that have not responded to at least two prior treatments. Eligible participants must have a confirmed diagnosis of specific lymphomas or leukemia, measurable disease, and adequate organ function. People with significant heart disease, uncontrolled HIV/AIDS, recent transplants, ongoing infections, or those on certain medications are excluded.

Inclusion Criteria

My kidney and liver tests are within normal ranges.
My cancer can be measured by specific guidelines.
Adequate hematologic parameters unless clearly due to the disease under study
See 2 more

Exclusion Criteria

My CLL has transformed into an aggressive type of lymphoma.
My leukemia is of the acute promyelocytic type.
My cancer has spread to my brain or spinal cord.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Open-label, 3 + 3 dose escalation study to determine the safety and preliminary efficacy of voruciclib monotherapy or in combination with venetoclax

Variable, up to 2 years

Treatment

Participants receive voruciclib monotherapy or voruciclib in combination with venetoclax

Variable, up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Venetoclax
  • Voruciclib
Trial Overview The study is testing the safety and potential effectiveness of voruciclib alone or combined with venetoclax in patients whose B-cell malignancy or AML has relapsed after standard therapies. It's an early-phase trial where dosages will be adjusted to find safe levels while monitoring how well the drugs work against these cancers.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: voruciclib monotherapy and voruciclib in combination with venetoclaxExperimental Treatment2 Interventions

Venetoclax is already approved in United States, European Union for the following indications:

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Approved in United States as Venclexta for:
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Approved in European Union as Venclyxto for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

MEI Pharma, Inc.

Lead Sponsor

Trials
14
Recruited
860+

Published Research Related to This Trial

Venetoclax is a highly effective treatment for relapsed or refractory chronic lymphocytic leukemia (CLL), achieving response rates of about 80% in clinical trials involving 240 patients from 2011 to 2016.
While venetoclax has an acceptable safety profile, common side effects include neutropenia and diarrhea, and there is a risk of tumor lysis syndrome (TLS), which can be managed through careful dose ramp-up and patient education, leading to no reported TLS events in ongoing trials.
Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia .Brumbaugh Paradis, H., Alter, D., Llerandi, D.[2018]
Venetoclax is an effective oral treatment for relapsed or refractory chronic lymphocytic leukemia (CLL), showing durable responses and a manageable safety profile in clinical trials, including patients with poor prognostic factors.
In combination with rituximab, venetoclax significantly improved progression-free survival and achieved undetectable minimal residual disease compared to bendamustine plus rituximab, with benefits lasting for at least 36 months.
Venetoclax: A Review in Relapsed/Refractory Chronic Lymphocytic Leukemia.Scott, LJ.[2020]
In the phase III CLL14 trial, a 12-month treatment with venetoclax combined with obinutuzumab significantly improved progression-free survival and rates of undetectable minimal residual disease compared to traditional chemoimmunotherapy with chlorambucil and obinutuzumab in patients with untreated chronic lymphocytic leukaemia.
Venetoclax + obinutuzumab is a well-tolerated, chemotherapy-free treatment option for CLL, with manageable side effects like neutropenia, making it suitable for patients who cannot undergo intensive chemotherapy.
Venetoclax: A Review in Previously Untreated Chronic Lymphocytic Leukaemia.Blair, HA.[2021]

Citations

Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia . [2018]
Venetoclax: A Review in Relapsed/Refractory Chronic Lymphocytic Leukemia. [2020]
Venetoclax: A Review in Previously Untreated Chronic Lymphocytic Leukaemia. [2021]
Venetoclax: First Global Approval. [2018]
Impact of Venetoclax Exposure on Clinical Efficacy and Safety in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia. [2018]
Efficacy and Safety of Bcl-2 Inhibitor Venetoclax in Hematological Malignancy: A Systematic Review and Meta-Analysis of Clinical Trials. [2020]
Chronic lymphocytic leukemia at ASH 2017. [2020]
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