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Voruciclib + Venetoclax for Leukemia and Lymphoma
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- 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.I have a serious heart condition.I need warfarin or cancer treatment drugs.I do not have any ongoing infections.I have been treated with a CDK9 inhibitor before.I have had pneumonitis before.My kidney and liver tests are within normal ranges.I have had a solid organ transplant.I am on low-dose steroids or topical/inhaled steroids for another condition.I am 18 years old or older.My cancer can be measured by specific guidelines.I had a transplant recently and am experiencing complications.My HIV is not under control, or I am on medication not allowed in this trial.I have been diagnosed with a specific type of blood cancer.My disease has returned or didn't respond to at least 2 treatments and is getting worse.
- Group 1: voruciclib monotherapy and voruciclib in combination with venetoclax
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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