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Monoclonal Antibodies

Epcoritamab for B-Cell Lymphoma

Q: Who would be an ideal candidate for this medical research study?

This clinical trial is now enrolling 15 youth aged between one year and 25. To qualify, participants must have Burkitt's or Burkitt-like <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>/<a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas; progressive disease at any time during second line chemoimmunotherapy; a minimum of 2 cycles of second line CIT with best response as stable disease or 3 cycles for partial response; recovery from toxic effects of prior chemoimmunotherapy verified by local testing; performance status according to Lansky (&#x3C; 16 years old) or Karn

Q: Does the criteria for this trial allow those over 20 years of age to participate?

According to the guidelines, individuals between 1 year and 25 years old are eligible for this trial. Furthermore, 593 trials exist specifically targetting patients under 18 while 3731 studies focus on participants over 65.

Q: What are the primary goals of this clinical research?

This medical trial, which is scheduled to take place over a 37-week period aims to measure the Maximum Observed Concentration (Cmax). Secondary objectives include assessing the Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy, Number of Participants who Achieve Overall Survival (OS), and Percentage of Participants Achieving Overall Response (OR).

Q: Is there a limit to the number of participants accepted into this clinical experiment?

This trial seeks 15 eligible participants from two separate sites: Phoenix Children's Hospital /ID# 239808 in <a href="https://www.withpower.com/clinical-trials/arizona">Arizona</a> and UCSF Helen Diller Family <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Research Building /ID# 239140 in <a href="https://www.withpower.com/clinical-trials/california">California</a>.

Q: Is recruitment for this clinical trial still open?

Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which was originally available on October 4th 2022, is currently recruiting patients to participate in the research program. Fifteen participants need to be enrolled from fifteen distinct locations.

Q: What potential complications can arise from using Epcoritamab?

Considering its Phase 1 status and limited safety data, the risk profile of epcoritamab was assessed to be a score of 1.

Q: Are there any North American sites administering this trial?

This clinical trial is accepting participants at 15 sites, such as Phoenix Children's Hospital (ID# 239808) in <a href="https://www.withpower.com/clinical-trials/arizona">Arizona</a>, UCSF Helen Diller Family <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Research Building (ID# 239140) in <a href="https://www.withpower.com/clinical-trials/california">California</a> and Nicklaus Children's Hospital (ID #241174) in <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>.

Phase 1

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Performance status by Lansky or Karnofsky score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2.

Relapsed or primary refractory disease meeting specific criteria including progressive disease, stable disease, partial response, complete response, inability to tolerate second-line CIT, and other conditions.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

Study Summary

This trial will assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia.

Who is the study for?

This trial is for children and young adults (up to age 25) with aggressive B-cell lymphomas that haven't responded well to previous treatments. They should be able to perform daily activities at a certain level, have no other cancers needing treatment, and not currently be on anti-cancer therapies.Check my eligibility

What is being tested?

The study tests Epcoritamab's safety and effects in patients with relapsed/refractory mature B-cell neoplasms. Participants will receive the drug through subcutaneous injections over cycles of 28 days and will be monitored for at least three years.See study design

What are the potential side effects?

Potential side effects include reactions at the injection site, general discomfort, possible immune system responses affecting organs, fatigue, blood-related issues, or infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

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

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I can do most activities but may need help.

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My cancer has returned or didn't respond to initial treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 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

Area Under the Concentration Versus Time Curve (AUC) from Time 0 to Time of Last Measurable Concentration within the Dosing Interval (AUCtau)

Maximum Observed Concentration (Cmax)

Number of Participants with Adverse Events (AE)

Secondary outcome measures

Duration of CR (DOCR)

Duration of response (DOR)

Number of Participants who Achieve Overall Survival (OS)

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: EpcoritamabExperimental Treatment1 Intervention

Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

GenmabIndustry Sponsor

56 Previous Clinical Trials

12,217 Total Patients Enrolled

AbbVieLead Sponsor

958 Previous Clinical Trials

502,369 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

147,083 Total Patients Enrolled

Media Library

Epcoritamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05206357 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Epcoritamab

Non-Hodgkin's Lymphoma Clinical Trial 2023: Epcoritamab Highlights & Side Effects. Trial Name: NCT05206357 — Phase 1

Epcoritamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05206357 — Phase 1

Frequently Asked Questions

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

Who would be an ideal candidate for this medical research study?

"This clinical trial is now enrolling 15 youth aged between one year and 25. To qualify, participants must have Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas; progressive disease at any time during second line chemoimmunotherapy; a minimum of 2 cycles of second line CIT with best response as stable disease or 3 cycles for partial response; recovery from toxic effects of prior chemoimmunotherapy verified by local testing; performance status according to Lansky (< 16 years old) or Karn"

Answered by AI

Does the criteria for this trial allow those over 20 years of age to participate?

"According to the guidelines, individuals between 1 year and 25 years old are eligible for this trial. Furthermore, 593 trials exist specifically targetting patients under 18 while 3731 studies focus on participants over 65."

Answered by AI

What are the primary goals of this clinical research?

"This medical trial, which is scheduled to take place over a 37-week period aims to measure the Maximum Observed Concentration (Cmax). Secondary objectives include assessing the Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy, Number of Participants who Achieve Overall Survival (OS), and Percentage of Participants Achieving Overall Response (OR)."

Answered by AI

Is there a limit to the number of participants accepted into this clinical experiment?

"This trial seeks 15 eligible participants from two separate sites: Phoenix Children's Hospital /ID# 239808 in Arizona and UCSF Helen Diller Family Cancer Research Building /ID# 239140 in California."

Answered by AI

Is recruitment for this clinical trial still open?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which was originally available on October 4th 2022, is currently recruiting patients to participate in the research program. Fifteen participants need to be enrolled from fifteen distinct locations."

Answered by AI

What potential complications can arise from using Epcoritamab?

"Considering its Phase 1 status and limited safety data, the risk profile of epcoritamab was assessed to be a score of 1."

Answered by AI

Are there any North American sites administering this trial?

"This clinical trial is accepting participants at 15 sites, such as Phoenix Children's Hospital (ID# 239808) in Arizona, UCSF Helen Diller Family Cancer Research Building (ID# 239140) in California and Nicklaus Children's Hospital (ID #241174) in Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab

2022. "Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05206357.

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