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Alkylating agents

Venetoclax for Non-Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Led By Basem William, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is studying giving venetoclax with carmustine, etoposide, cytarabine, and melphalan before stem cell transplant to see how well it works and what the side effects are.

Eligible Conditions

Non-Hodgkin's Lymphoma
Follicular Lymphoma
Marginal Zone Lymphoma
Diffuse Large B-Cell Lymphoma
Bone Marrow Transplant Recipient
Transformed Indolent Non-Hodgkin Lymphoma
B-Cell Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Maximum tolerated dose of venetoclax defined to be the dose cohort below which 3 out of 6 patients experience dose limiting toxicities or the highest dose cohort of 1200 mg, if 2 dose limiting toxicities are not observed at any dose cohort

Overall response rate

Secondary outcome measures

Incidence of freedom from relapse

Incidence of progression

Overall survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (venetoclax, BEAM)Experimental Treatment6 Interventions

Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mechlorethamine

FDA approved

Cytarabine

FDA approved

Venetoclax

FDA approved

Carmustine

FDA approved

Etoposide

FDA approved

Hematopoietic Cell Transplantation

2006

Completed Phase 2

~360

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,148 Total Patients Enrolled

Basem William, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Kami Maddocks, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

5 Previous Clinical Trials

261 Total Patients Enrolled

Frequently Asked Questions

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

Are there any vacant positions in this trial for potential participants?

"The aforementioned website details that this particular clinical trial is not currently looking for patients. This study was first made public on September 10th, 2018 and underwent its last editing on September 29th, 2021. Despite this research project no longer being open to new participants, there are 3516 other studies which are presently recruiting individuals."

Answered by AI

How many people total have signed up for this experiment?

"This particular clinical trial is no longer looking for new candidates, as the last update was on September 29th, 2021. That said, there are 2784 trials actively recruiting patients with lymphoma and 732 studies using Venetoclax if you are interested in other options."

Answered by AI

What are some common ailments that Venetoclax helps to address?

"Venetoclax has shown efficacy in the treatment of merkel cell cancer, as well as other diseases like meningeal leukemia, prostate cancer, and small cell lung cancer."

Answered by AI

What is the precedent for using Venetoclax in patient care?

"732 clinical trials are being conducted worldwide for Venetoclax. Out of those, 162 have reached Phase 3 testing. Edmonton, Alberta has the most studies with 28768 locations running trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Venetoclax, Carmustine, Etoposide, Cytarabine, and Melphalan Before Stem Cell Transplant in Treating Participants With Relapsed or Refractory Non-Hodgkin Lymphoma

Kami Maddocks 2018. "Venetoclax, Carmustine, Etoposide, Cytarabine, and Melphalan Before Stem Cell Transplant in Treating Participants With Relapsed or Refractory Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03583424.