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Histone Deacetylase Inhibitor

Venetoclax for Anaplastic Lymphoma

Phase 2
Waitlist Available
Led By Jasmine M Zain
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be willing to provide tissue
Failed at least 2 prior systemic therapies. For anaplastic large cell lymphoma (ALCL) histologies this must include failure or intolerable side effects of brentuximab vedotin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and at the end of cycle 1 or 2 (each cycle is 28 days)
Awards & highlights

Study Summary

This trial looks at the side effects and best dose of two drugs, venetoclax and romidepsin, to treat patients with a type of lymphoma that has come back or does not respond to treatment.

Eligible Conditions
  • Anaplastic Lymphoma
  • T-Cell and NK-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are willing to give a small sample of your tissue for testing.
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You have tried and did not respond well to at least two different treatments before. If you have a specific type of lymphoma called anaplastic large cell lymphoma, one of the treatments you tried must have been brentuximab vedotin and it didn't work or caused severe side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and at the end of cycle 1 or 2 (each cycle is 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at the end of cycle 1 or 2 (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With Grade 3 or Above Toxicities
Secondary outcome measures
Overall Survival at 100 Days
Other outcome measures
Change in Bcl-2 gene expression

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Anaemia
11%
Gastroenteritis
11%
Abdominal pain
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
Pneumonia pseudomonal
11%
Sepsis
11%
Dermatitis
11%
Pneumonia
11%
Blood creatinine increased
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Neutrophil count decreased
11%
COVID-19
11%
Supraventricular tachycardia
11%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (venetoclax, romidepsin)Experimental Treatment3 Interventions
Patients receive venetoclax PO QD on days 1-28 and romidepsin IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Romidepsin
2011
Completed Phase 2
~790
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,439 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,914,150 Total Patients Enrolled
Jasmine M ZainPrincipal InvestigatorCity of Hope Medical Center

Media Library

Romidepsin (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03534180 — Phase 2
Anaplastic Lymphoma Research Study Groups: Treatment (venetoclax, romidepsin)
Anaplastic Lymphoma Clinical Trial 2023: Romidepsin Highlights & Side Effects. Trial Name: NCT03534180 — Phase 2
Romidepsin (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03534180 — Phase 2

Frequently Asked Questions

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

How many people are being given the opportunity to participate in this clinical trial?

"Unfortunately, this study is not currently looking for new participants. Although, it is worth noting that the trial was first posted on 8/21/2018 and was most recently updated on 7/26/2022. Additionally, if you are exploring other studies, there are presently 1808 trials actively recruiting participants with recurrent mature t- cell and nk-cell non-hodgkin lymphoma and 243 trials for Venetoclax actively recruiting participants."

Answered by AI

Have patients undergone this kind of treatment before?

"Celgene Corporation's Venetoclax has been involved in 659 trials since it first began Phase 1 drug approval in 2012. Out of those, 243 are still considered active studies spread across 1218 cities and 46 countries."

Answered by AI

Is Venetoclax a common medication in research trials?

"Originally, Venetoclax was studied in 2012 by the research team at Johns Hopkins University/Sidney Kimmel Cancer Center. Since that initial exploration, there have been a total of 659 completed clinical trials. Right now, 243 different venetoclax trials are actively recruiting patients; many of these studies are based in Omaha, Nebraska."

Answered by AI

What goals does this clinical trial hope to achieve?

"The purpose of this study, which will last for up to two years, is to track the number of adverse events. Additionally, researchers will be measuring 'time to response' and 'complete response rate' in order to better understand the efficacy of the medication being trialed. Lastly, they will also be studying overall survival rates."

Answered by AI

What is the FDA's current stance on Venetoclax?

"While there is some data supporting Venetoclax's safety, it only received a score of 2 because this is still early in the clinical trial process."

Answered by AI

Are there any remaining subject positions available for this research?

"This particular clinical trial is no longer looking for participants. However, if you are still interested in finding a study, there are 1808 other trials actively recruiting patients with recurrent mature t- cell and nk-cell non-hodgkin lymphoma and 243 studies involving Venetoclax that are currently enrolling patients."

Answered by AI
~2 spots leftby Mar 2025