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B-cell Lymphoma-2 (BCL-2) Inhibitor

Voruciclib + Venetoclax for Leukemia and Lymphoma

Phase 1

Recruiting

Research Sponsored by MEI Pharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate renal and hepatic function, per laboratory reference range at screening

Age ≥18 years

Must not have

For CLL subjects: only known histological transformation to an aggressive lymphoma

For AML subjects: Acute promyelocytic leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical ones for cancer drugs like voruciclib and venetoclax may include nausea, diarrhea, fatigue, low blood cell counts leading to increased infection risk and bleeding problems. Liver and kidney functions might also be affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney and liver tests are within normal ranges.

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I am 18 years old or older.

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I have been diagnosed with a specific type of blood cancer.

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My disease has returned or didn't respond to at least 2 treatments and is getting worse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My CLL has transformed into an aggressive type of lymphoma.

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My leukemia is of the acute promyelocytic type.

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My cancer has spread to my brain or spinal cord.

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I have a serious heart condition.

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I need warfarin or cancer treatment drugs.

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I do not have any ongoing infections.

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I have been treated with a CDK9 inhibitor before.

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I have had pneumonitis before.

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I have had a solid organ transplant.

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I had a transplant recently and am experiencing complications.

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My HIV is not under control, or I am on medication not allowed in this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the safety and tolerability of voruciclib

Determine the safety and tolerability of voruciclib in combination with venetoclax in subjects with AML.

Secondary study objectives

Duration of Response (DOR)

Evaluate the PK of voruciclib

Evaluate the PK of voruciclib Cmax in combination with venetoclax Determined by the Area Under the Concentration time curve (AUC)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: voruciclib monotherapy and voruciclib in combination with venetoclaxExperimental Treatment2 Interventions

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

0 / 15Eligibility criteria met