← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My kidney and liver tests are within normal ranges.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with a specific type of blood cancer.
Select...
My disease has returned or didn't respond to at least 2 treatments and is getting worse.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the safety and tolerability of voruciclib
Determine the safety and tolerability of voruciclib in combination with venetoclax in subjects with AML.
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

MEI Pharma, Inc.Lead Sponsor
13 Previous Clinical Trials
778 Total Patients Enrolled

Media Library

Venetoclax (B-cell Lymphoma-2 (BCL-2) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03547115 — Phase 1
Acute Myeloid Leukemia Research Study Groups: voruciclib monotherapy and voruciclib in combination with venetoclax
Acute Myeloid Leukemia Clinical Trial 2023: Venetoclax Highlights & Side Effects. Trial Name: NCT03547115 — Phase 1
Venetoclax (B-cell Lymphoma-2 (BCL-2) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03547115 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently participating in this experiment?

"A total of 100 suitable participants are necessary for the study to commence. MEI Pharma, Inc., is in charge of this trial and has selected University of Nebraska Medical Center (Omaha) and Oregon Health and Science University (Portland) as its locations."

Answered by AI

What is the current scope of this clinical trial's implementation?

"This study has 10 active sites, including Omaha, Portland and Seattle. It is recommended that potential participants choose the closest location to reduce travel costs."

Answered by AI

Has voruciclib been sanctioned by the FDA?

"The safety of the medication voruciclib has been assessed as a 1 due to its Phase 1 trial status, indicating limited data around efficacy and safety."

Answered by AI

Are there any available slots left in this experiment for participants?

"Affirmative. Clinicaltrials.gov data indicates that the recruitment process for this trial is ongoing, with a commencement date of May 31st 2018 and most recent edit being August 10th 2022. 100 participants will be sourced from 10 different medical centres."

Answered by AI

What is the overall intent of this clinical examination?

"The primary purpose of this trial, lasting approximately two years, is to assess the safety and tolerability of voruciclib. Secondary objectives include determining peak plasma concentration (Cmax) for Voruciclib when taken independently or in combination with Venetoclax; assessing area under the curve (AUC); and measuring overall response rate (ORR), which includes complete responses (CR/CRi), partial responses (PR) among B-cell malignancies or CR/CRi rates according to 2017 European LeukemiaNet criteria in AML patients."

Answered by AI

Is voruciclib being studied for potential clinical applications in other contexts?

"As of now, voruciclib is the subject of one ongoing trial and zero phase 3 trials. Whilst numerous clinical sites in Milwaukee are looking into this medication, there are a total 11 facilities examining its potential effects."

Answered by AI

Is this investigation the inaugural effort of its kind?

"Currently, MEI Pharma, Inc. is conducting a single clinical trial across 11 cities and 1 country to evaluate the efficacy of voruciclib. This research first began in 2018 with 100 participants and has since completed its Phase 1 approval stage; however, no further trials have been finished."

Answered by AI
~1 spots leftby Apr 2024