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AVM0703 for Lymphoma (OPAL Trial)

Phase 1 & 2
Recruiting
Led By Michaela Tsai, MD
Research Sponsored by AVM Biotechnology Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have relapsed or refractory (R/R) disease with prior therapies defined
Lansky (12 to 15 years of age) or Karnofsky (≥16 years of age) performance status ≥50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year two
Awards & highlights

OPAL Trial Summary

This trial is studying a new cancer treatment to determine if it is safe and effective.

Who is the study for?
This trial is for people aged 12 and older, weighing more than 40 kg, with certain types of lymphoid malignancies that have not responded to previous treatments or who cannot receive them due to various reasons. Participants need a minimum level of physical health and organ function, must not be pregnant or breastfeeding, and agree to use contraception.Check my eligibility
What is being tested?
The OPAL Study is testing AVM0703 as a single IV infusion for patients with lymphoid malignancies. It's an open-label study which means everyone knows what treatment they're getting. The focus is on safety, how the body processes the drug (pharmacokinetics), tolerability, and initial effectiveness against tumors.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones from similar trials may include reactions at the infusion site, fatigue, fever, nausea or vomiting. Since it's a Phase 1/2 study focusing on safety and tolerability; monitoring for any adverse effects will be a key part of this trial.

OPAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition did not improve or worsened after previous treatments.
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I can do most activities but may need help.
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I am 12 years or older and weigh at least 40 kg.
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I am mostly able to carry on with normal activities or take care of myself.
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My cancer is one of the specific types listed by the WHO.
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I can understand and am willing to sign the consent form and follow the study rules.
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I am not pregnant and will use effective birth control during and after the study.
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I don't have severe shortness of breath and my oxygen level is above 92% without assistance.
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My cancer is one of the specific types listed by the WHO.
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I am 12 years or older and weigh more than 40 kg.

OPAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year one
This trial's timeline: 3 weeks for screening, Varies for treatment, and year one for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: incidence of Adverse events
Secondary outcome measures
Phase 2: ORR

OPAL Trial Design

6Treatment groups
Experimental Treatment
Group I: Primary Mediastinal Large B-cell lymphomaExperimental Treatment1 Intervention
Primary mediastinal large B-cell lymphoma
Group II: MCL (Chronic Lymphoid Leukemia)Experimental Treatment1 Intervention
Chronic Lymphoid Leukemia
Group III: DLBCL and high-grade B-cell lymphomaExperimental Treatment1 Intervention
Diffuse Large Cell B-Lymphoma High-grade B-cell Lymphoma
Group IV: CLL/SLLExperimental Treatment1 Intervention
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Group V: Burkitt or Burkitt-like lymphoma/leukemiaExperimental Treatment1 Intervention
Burkitt or Burkitt-like lymphoma/leukemia
Group VI: B- or T-ALLExperimental Treatment1 Intervention
B-lymphoblastic leukemia/lymphoma, T-lymphoblastic leukemia/lymphoma, acute leukemia/lymphoma, acute leukemias of ambiguous lineage, or natural killer (NK) cell lymphoblastic leukemia/lymphoma

Find a Location

Who is running the clinical trial?

AVM Biotechnology IncLead Sponsor
2 Previous Clinical Trials
16 Total Patients Enrolled
1 Trials studying Lymphoma
AVM Biotechnology LLCLead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
29,471 Total Patients Enrolled

Media Library

AVM0703 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04329728 — Phase 1 & 2
Lymphoma Research Study Groups: MCL (Chronic Lymphoid Leukemia), Primary Mediastinal Large B-cell lymphoma, Burkitt or Burkitt-like lymphoma/leukemia, B- or T-ALL, CLL/SLL, DLBCL and high-grade B-cell lymphoma
Lymphoma Clinical Trial 2023: AVM0703 Highlights & Side Effects. Trial Name: NCT04329728 — Phase 1 & 2
AVM0703 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04329728 — Phase 1 & 2

Frequently Asked Questions

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

How many care centers are participating in this research project?

"Currently, this trial has 9 enrolment sites including Omaha, Memphis, and Minneapolis."

Answered by AI

Are we currently accepting people into this clinical trial?

"The trial is still recruiting patients, based on the latest information from clinicaltrials.gov. The posting went up on November 6th, 2020, with the most recent update being from October 10th, 2022."

Answered by AI

Can you tell me if AVM0703 has undergone any other medical research trials in the past?

"AVM0703 was first researched in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Out of the 1098 completed studies, 575 are still ongoing. The majority of these ongoing trials are based in Omaha, Nebraska."

Answered by AI

What are the main conditions that AVM0703 has been shown to improve?

"AVM0703 is used to treat various ocular conditions, such as sympathetic ophthalmia, branch retinal vein occlusion, and macular edema."

Answered by AI

Are young adults eligible to participate in this research project?

"According to the inclusion criteria listed on this trial, patients aged 12 to 95 are eligible to apply. There are 392 similar studies for patients under 18 and 2751 for those over 65."

Answered by AI

To whom does this study extend an invitation for participation?

"This clinical trial is admitting 144 participants, between the ages of 12 and 95 who have cancer. It is important that patients also meet the following criteria: 1. Age ≥12 years and weight >40 kg;, CLL/SLL; or B-lymphoblastic leukemia/lymphoma, T-lymphoblastic leukemia/lymphoma, acute leukemia/lymphoma, acute leukemias of ambiguous lineage, or NK cell lymphoblastic leukemia/lymphoma;, R/R after CAR T therapy; or Ineligible for autologous HCT or CAR T therapy due to"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies
2020. "The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04329728.
~28 spots leftby Apr 2025
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