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Alkylating agents

Induction Venetoclax for Follicular Lymphoma (PrE0403 Trial)

Phase 2
Waitlist Available
Research Sponsored by PrECOG, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have no recent history of malignancy except for adequately treated basal cell or squamous cell skin cancer, Stage I melanoma of the skin, or in situ cervical cancer. Individuals in documented remission without treatment for ≥ 2 years prior to enrollment may be included at the discretion of the investigator.
Willing to provide mandatory tissue samples (if sufficient tissue available) for research purposes.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

PrE0403 Trial Summary

This trial is studying the side effects of adding venetoclax to obinutuzumab and bendamustine in treating patients with follicular lymphoma.

Eligible Conditions
  • Follicular Lymphoma
  • Non-Hodgkin's Lymphoma

PrE0403 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You cannot have had any cancer recently, except for certain types of skin and cervical cancer that have been treated and are in remission for at least 2 years.
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You agree to provide a tissue sample for research if there is enough available.
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You do not have any current infections that are not being treated or controlled.

PrE0403 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response (CR) at End of Induction
Secondary outcome measures
Convert to CR During Maintenance Therapy (From PR in Induction)
Number of Participants With Treatment-related GRADE 3+ Adverse Events as Assessed by CTCAE V4.0
Overall Response Rate (ORR)
+3 more

Side effects data

From 2023 Phase 2 trial • 56 Patients • NCT03113422
82%
Nausea
61%
Fatigue
46%
Vomitting
43%
Diarrhea
41%
Thrombocytopenia
38%
Neutropenia
29%
Headache
27%
Decreased appetite
21%
Anemia
20%
Infusion related reaction
18%
Hyperuricemia
18%
Constipation
18%
AST/ALT increase
14%
Tumor lysis syndrome
7%
Pyrexia
5%
Lung infection
4%
Cellulitis
4%
Back pain
2%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Obinutuzumab + Bendamustine + Venetoclax Induction

PrE0403 Trial Design

2Treatment groups
Experimental Treatment
Group I: Maintenance VenetoclaxExperimental Treatment1 Intervention
Patients with stable or improved disease will receive venetoclax by mouth daily for 24 cycles (1 cycle=1 month) and obinutuzumab IV every 2 months for 12 cycles. Patients with no evidence of disease will receive obinutuzumab IV every 2 months for 12 cycles.
Group II: Induction VenetoclaxExperimental Treatment1 Intervention
Cycle 1-6: Obinutuzumab intravenously (IV) and bendamustine IV. Cycle 2-6: Venetoclax (oral)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Induction Venetoclax
2017
Completed Phase 2
~60
Maintenance Venetoclax
2017
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

PrECOG, LLC.Lead Sponsor
17 Previous Clinical Trials
7,402 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,624 Total Patients Enrolled
Nishitha M Reddy, MDStudy ChairVanderbilt-Ingram Cancer Center

Frequently Asked Questions

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

What potential dangers are associated with Induction Venetoclax use?

"Although Induction Venetoclax has not yet been clinically proven to be effective, it is considered moderately safe due to some supporting data; thus, Power assigned the drug a score of 2."

Answered by AI

Are there any participating institutions currently executing this research project in the local vicinity?

"Ten trial sites are participating in this medical research. Participants can find locations at the Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Washington University School of Medicine, and Mayo Clinic Rochester among others."

Answered by AI

How many participants are currently undergoing the research protocol?

"At present, this medical trial has concluded its recruitment process. First appearing on December 27th 2017 and last updated July 13th 2022, it is no longer seeking participants for the study. However, there are currently 1751 trials researching lymphoma and 219 other studies related to induction venetoclax that remain open to new enrolments."

Answered by AI

Are there any prior experiments which have utilized Induction Venetoclax?

"Currently, 28 Phase 3 trials of Induction Venetoclax are ongoing and encompass 219 individual studies. Although Boston is the epicentre for such research, there are an impressive 7198 locations worldwide conducting this type of trial."

Answered by AI

Is this experiment open to new participants at present?

"The clinicaltrials.gov database does not indicate that this research project is currently recruiting patients, despite its initial posting on December 27th 2017 and last update on July 13th 2022. However, there are 1970 other studies actively searching for participants right now."

Answered by AI
~8 spots leftby Mar 2025