← Back to Search

Monoclonal Antibodies

VAY736 + Antineoplastic Agents for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Must have measurable disease and ECOG of 0 to 2

Adult patients with confirmed diagnosis of relapsed/refractory B-cell NHL with all subtypes of DLBCL, follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) per WHO 2016 criteria. Patients in subtype arm e.g. DLBCL must have confirmed diagnosis of relapsed/refractory DLBCL.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial is testing a new drug for safety, how well it works, and how it affects the body. It will be given to patients with NHL alone or with other therapies.

Who is the study for?

This trial is for adults with certain types of B-cell Non-Hodgkin Lymphoma that have tried at least two prior treatments without success. Participants must be able to undergo biopsies and have a performance status allowing daily activity. Excluded are those with central nervous system lymphoma, severe heart or lung conditions, HIV, active hepatitis infections, or women who could become pregnant and aren't using contraception.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of VAY736 alone or combined with other drugs (CC-99282, lenalidomide) in patients with relapsed/refractory Non-Hodgkin Lymphoma. It will evaluate how the body processes these drugs and their preliminary effects on the disease.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to monoclonal antibodies like VAY736, changes in blood counts or immune responses due to lenalidomide or CC-99282 therapy. Specific side effect profiles will depend on individual patient factors.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have cancer that can be measured and I can care for myself.

Select...

I have a type of B-cell NHL that has come back or didn't respond to treatment.

Select...

I have tried at least two treatments for my NHL, including one targeting CD20, without success.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

Dose intensity

Incidence and nature of dose limiting toxicities (DLTs)

Incidence of Adverse events (AEs) and serious adverse events (SAEs)

+1 more

Secondary outcome measures

Area under curve (AUC) for VAY736 and combination partners

Best overall response (BOR) rate

Change from baseline in anti-drug antibodies (ADA)

+2 more

Side effects data

From 2018 Phase 2 trial • 27 Patients • NCT02149420

75%

Infusion related reaction

33%

Nasopharyngitis

17%

Headache

Fatigue

Cystitis

Rash

Sinusitis

Iron deficiency anaemia

Back pain

Conjunctivitis

Myalgia

Gastroenteritis

Gastrointestinal infection

Influenza

100%

80%

60%

40%

20%

Study treatment Arm

VAY736 10mg/kg

VAY736 3mg/kg

Placebo

Open Label VAY736 10mg/kg

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm 2BExperimental Treatment2 Interventions

VAY736 + lenalidomide dose expansion in patients with DLBCL. This arm will not be conducted.

Group II: Arm 2AExperimental Treatment2 Interventions

VAY736 + lenalidomide dose escalation in patients with DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). Enrollment has been halted in this arm.

Group III: Arm 1BExperimental Treatment1 Intervention

VAY736 single agent dose expansion in patients with DLBCL

Group IV: Arm 1AExperimental Treatment1 Intervention

VAY736 single agent dose escalation in patients with NHL subtypes of diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VAY736

2014

Completed Phase 2

~290

lenalidomide

2012

Completed Phase 3

~3920

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,859 Previous Clinical Trials

4,198,204 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,640 Previous Clinical Trials

4,129,424 Total Patients Enrolled

Novartis Institutes of Biomedical ResearchStudy DirectorNovartis Institutes of Biomedical Research

Media Library

VAY736 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04903197 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Arm 1A, Arm 1B, Arm 2A, Arm 2B

Non-Hodgkin's Lymphoma Clinical Trial 2023: VAY736 Highlights & Side Effects. Trial Name: NCT04903197 — Phase 1

VAY736 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04903197 — Phase 1

Frequently Asked Questions

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

What is the established level of security associated with VAY736?

"VAY736 has limited data supporting both its safety and efficacy, so it received a low score of 1."

Answered by AI

Is the current research study seeking additional participants?

"Per the data found on clinicaltrials.gov, this medical trial is currently searching for suitable participants. The pool of potential patients was first opened up to recruitment on January 24th 2022 and has since been updated as recently as November 28th 2022."

Answered by AI

What is the scale of enrollment for this clinical trial?

"Affirmative. The clinical trial's posting, which dates back to January 24th 2022, is still actively recruiting patients. 86 participants are needed across two different medical sites."

Answered by AI

What purpose is VAY736 typically used for in medical care?

"VAY736 is a common medication for the treatment of multiple myeloma, as well as lymphomas that have relapsed or become resistant to initial treatments and chronic lymphocytic leukemia after two prior chemotherapy rounds."

Answered by AI

Has any prior research been conducted with VAY736?

"First investigated at Saint Joseph Regional Medical Center-Mishawaka in 2004, VAY736 has seen 350 completed trials. At present, 274 are still ongoing with the majority occurring in Houston, Texas."

Answered by AI

What aims is this experiment seeking to achieve?

"According to the trial sponsor, Novartis Pharmaceuticals, this clinical study will span a period of 4 years and evaluate Incidence and nature of dose limiting toxicities (DLTs) as its primary endpoint. Additionally, secondary endpoints such as AUC for lenalidomide, Cmax for lenalidomide, and Change from baseline in anti-drug antibodies (ADA) are also being measured; plasma concentrations are necessary for PK parameters while blood samples must be collected for detecting changes in antibody levels."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma

2022. "Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04903197.

All > Marginal Zone Lymphoma