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Monoclonal Antibodies

VENOM for Lymphoma

Phase 1

Waitlist Available

Led By Mark J Roschewski, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

ECOG performance status less than or equal to 2

Participant must have relapsed and/or refractory disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of the treatment until disease progression/recurrence

Awards & highlights

Study Summary

This trial is testing a new combination of drugs for B-cell lymphoma. The drugs are Magrolimab, Obinutuzumab and Venetoclax. The trial will find out if it is safe to give the combination of drugs to people with B-cell lymphomas.

Who is the study for?

Adults over 18 with certain slow-growing B-cell lymphomas that have come back or worsened after treatment can join. They must have tried at least two treatments before, including one with an anti-CD20 drug, and not been on CD47/SIRP alpha targeting agents. Participants need enough healthy tissue for testing, measurable disease signs, good organ function, and agree to use contraception.Check my eligibility

What is being tested?

The VENOM trial is testing a new drug combo: Venetoclax taken orally daily plus Obinutuzumab and Magrolimab given through IV infusions in 28-day cycles for about 8 months. The goal is to see if this mix is safe for people with relapsed or stubborn B-cell lymphomas.See study design

What are the potential side effects?

Possible side effects include reactions where the drugs enter the body, low blood cell counts leading to increased infection risk or bleeding problems, liver issues signaled by yellowing skin/eyes or dark urine, tiredness, upset stomach like nausea/vomiting/diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My disease has returned or is not responding to treatment.

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My cancer can be measured or observed.

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I have a type of slow-growing B-cell lymphoma and have tried at least two treatments, including one targeting CD20.

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My lymphoma is a slow-growing type and tests positive for CD20.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ initiation of study drug until 30 days after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~initiation of study drug until 30 days after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and initiation of study drug until 30 days after last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and tolerability

Secondary outcome measures

Complete molecular remission (MRD negativity) in CLL patients

Duration of response

Event-free survival

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Experimental treatment: mzl, MCL, CLL dose expansionExperimental Treatment3 Interventions

Window of magrolimab IV with a 1 mg/kg priming dose followed by 30mg/kg loading and maintenance doses + obinutuzumab IV 1000mg combination for two (2) cycles (28-day cycles, Cycles -2 and -1), then venetoclax safety ramp-up to target dose (dose determined from Arm 2) over 5 weeks (35-days, Cycle 1). Triplet combination treatment with magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for 5 additional cycles (28-days each, Cycles 2-6); further treatment will be response-adapted.

Group II: Experimental treatment: MZL, MCL, and CLL Dose-findingExperimental Treatment3 Interventions

Magrolimab IV with a 1 mg/kg priming dose followed by 30mg/kg loading and maintenance doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. Note: DLT assessment of the magrolimab + obinutuzumab + venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at DL(-1) of venetoclax 200mg with magrolimab and obinutuzumab.

Group III: Experimental treatment: FL dose expansionExperimental Treatment3 Interventions

Window of magrolimab IV with a 1 mg/kg priming dose followed by 30mg/kg loading and maintenance doses + obinutuzumab IV 1000mg combination for two (2) cycles (28-days each, Cycles -2 and -1), then venetoclax will be added at target dose (dose determined from Arm 1). Triplet combination treatment with magrolimab + obinutuzumab + venetoclax will be 6 cycles (28-days each, Cycles 1-6); further treatment will be response-adapted.

Group IV: Experimental treatment: FL Dose-findingExperimental Treatment3 Interventions

Magrolimab IV with a 1 mg/kg priming dose followed by 30mg/kg loading and maintenance doses + obinutuzumab IV 1000mg + venetoclax 800mg PO combination administered to 6 patients for six (6) cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: DLT assessment of the magrolimab + obinutuzumab + venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at DL(-1) of venetoclax 600mg with magrolimab and obinutuzumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

Obinutuzumab

2015

Completed Phase 3

~3250

Magrolimab

2021

Completed Phase 2

~170

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,924,271 Total Patients Enrolled

Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)

18 Previous Clinical Trials

2,163 Total Patients Enrolled

Frequently Asked Questions

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

For what capacity is this clinical trial currently recruiting participants?

"Affirmative. Clinicaltrials.gov displays information affirming that, as of 11/3/2022, this clinical trial is actively enrolling patients. It was initially posted on 12/16/2021 and seeks to admit 76 participants at a single medical centre."

Answered by AI

What medical conditions generally require the use of Venetoclax?

"Venetoclax has been found to be effective in managing lymphoid leukemia, refractory follicular lymphoma, and chronic lymphocytic leukaemia (CLL)."

Answered by AI

Has the government green-lighted Venetoclax for public use?

"With only limited data supporting safety and efficacy, our team at Power has rated the usage of Venetoclax a 1 on the scale from 1 to 3."

Answered by AI

Has Venetoclax been investigated in any other scientific researches?

"Currently, there are 293 clinical trials being conducted on Venetoclax with 36 of those in the third phase. While Edmonton, Alberta is one locale where these studies are taking place, globally there are 9053 sites conducting research into this drug's efficacy."

Answered by AI

Are there any available slots in this medical trial that require participants?

"According to clinicialtrials.gov, this research endeavour is currently recruiting participants and was initially posted on December 16th 2021 before its most recent update of November 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies

2021. "Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04599634.

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