Venetoclax for Non-Hodgkin's Lymphoma

Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA
Non-Hodgkin's Lymphoma+7 More ConditionsVenetoclax - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing the combination of venetoclax, lenalidomide, and rituximab hyaluronidase to treat patients with relapsed or refractory low-grade lymphoma. The goal is to find the maximum tolerated dose of venetoclax and to learn about the side effects of this combination.

Eligible Conditions
  • Non-Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia (CLL)
  • Refractory Marginal Zone Lymphoma
  • Refractory Follicular Lymphoma
  • Recurrent Follicular Lymphoma
  • Refractory Indolent Adult Non-Hodgkin Lymphoma
  • Recurrent Marginal Zone Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Time from study registration to death from any cause, assessed at 2 years

Day 42
Metabolic landscape
Day 42
Level of expression and expression ratio between anti-apoptotic and pro-apoptotic BCL-2 family proteins measured by flow cytometry and messenger ribonucleic acid (mRNA)
Day 42
Immune profile
Month 12
Overall response rate
Day 56
Rate of dose-limiting toxicities
Year 2
Overall survival (OS)
Year 2
Progression-free survival (PFS)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Treatment (venetoclax, lenalidomide, rituximab, hyaluronidase)
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Venetoclax · No Placebo Group · Phase 1

Treatment (venetoclax, lenalidomide, rituximab, hyaluronidase)Experimental Group · 4 Interventions: Venetoclax, Lenalidomide, Rituximab, Rituximab and Hyaluronidase Human · Intervention Types: Drug, Drug, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Lenalidomide
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time from study registration to death from any cause, assessed at 2 years

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
416 Previous Clinical Trials
136,784 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,281 Previous Clinical Trials
41,235,103 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Is this experiment actively inviting participation from volunteers?

"Indeed, the trial is currently admitting participants. According to clinicaltrials.gov, it was first posted on October 16th 2020 and edited most recently on April 7th 2022; 30 individuals are needed at a single site for participation." - Anonymous Online Contributor

Unverified Answer

What indications is Venetoclax commonly proscribed for?

"Venetoclax is a popular medication for treating diffuse large b-cell lymphoma (dlbcl). Additionally, it can be used to address inflammatory breast cancer (ibc) and other B-Cell Lymphomas that have not responded to prior systemic chemotherapy regimens." - Anonymous Online Contributor

Unverified Answer

What is the total sample size for this medical experiment?

"Affirmative. The information published on clinicaltrials.gov demonstrates that the trial, which was initially posted in October 16th 2020 is currently recruiting subjects. 30 individuals need to be enrolled at one medical facility." - Anonymous Online Contributor

Unverified Answer

To what extent does Venetoclax pose a risk to patients?

"The team at Power assigned Venetoclax a score of 1 due to its Phase 1 designation, indicating that there is limited evidence supporting the drug's safety and efficacy." - Anonymous Online Contributor

Unverified Answer

Are there any other trials that have utilized Venetoclax for therapeutic benefit?

"At present, there are 825 Venetoclax studies in progress with 170 of them reaching Phase 3. Toronto is the location for many of these trials while a total of 32578 sites provide access to clinical testing involving Venetoclax." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.