What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as high-dose chemotherapy followed by blood stem cell transplantation, can cause a range of severe side effects. These include damage to healthy tissues leading to complications in the blood, immune, and gastrointestinal systems, as well as other vital organs. Patients may experience cardiotoxicity, infertility, neurocognitive dysfunction, and an increased risk of secondary cancers. Additionally, there can be significant fatigue, anxiety, and depression. Preventive and supportive care therapies are typically administered to manage these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma that aim to manage chemotherapy-related complications. Rituximab, an anti-CD20 monoclonal antibody, is often used in combination with chemotherapy to enhance efficacy and reduce relapse rates. Additionally, supportive care drugs like filgrastim (G-CSF) are approved to mitigate neutropenia, a common side effect of high-dose chemotherapy. Palifermin is another FDA-approved drug that helps reduce the incidence and duration of severe oral mucositis in patients undergoing hematopoietic stem cell transplantation. These treatments collectively aim to improve patient outcomes by managing the adverse effects associated with intensive chemotherapy regimens.

What other types of research exist?

Promising novel alternatives to AB-205 for preventing or reducing chemotherapy-related complications in Non-Hodgkin's Lymphoma patients include the use of monoclonal antibodies such as rituximab in combination with standard chemotherapy regimens (e.g., CHOP). Additionally, gemcitabine has shown efficacy in relapsed or refractory aggressive NHL and may offer a therapeutic option. These alternatives should be discussed with a healthcare provider to tailor the best treatment plan for the individual patient.

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AB-205 for Lymphoma (E-CELERATE Trial)

Phase 3

Waitlist Available

Research Sponsored by Angiocrine Bioscience

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new treatment called AB-205 to see if it can reduce severe side effects in lymphoma patients who are receiving high-dose chemotherapy and blood stem cell transplants. These patients often suffer from serious complications due to the chemotherapy. AB-205 might help protect their healthy tissues and reduce these risks.

Who is the study for?

Adults over 40 with Hodgkin or non-Hodgkin lymphoma, in partial or complete remission, can join this trial. They must be fit enough for high-dose chemotherapy and stem cell transplant, have good heart and lung function, normal liver enzymes, a creatinine clearance of at least 30 ml/min, and not exceed a certain weight limit. Participants must agree to use two forms of contraception if they are sexually active.

What is being tested?

The study tests whether AB-205 can prevent or lessen severe complications from high-dose chemotherapy in lymphoma patients undergoing stem cell transplants compared to a placebo. All participants will receive standard care alongside the test drug or placebo.

What are the potential side effects?

Potential side effects aren't specified here but may include reactions related to immune system suppression due to chemotherapy and transplantation procedures such as infections, bleeding issues, nausea, fatigue among others.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AB-205 plus standard-of-care preventive and supportive therapies.Experimental Treatment1 Intervention

Group II: Placebo plus standard-of-care preventive and supportive therapies.Placebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AB-205

2019

Completed Phase 1

~50

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include high-dose chemotherapy followed by blood stem cell transplantation. High-dose chemotherapy targets and kills rapidly dividing cancer cells but also harms healthy tissues, causing severe complications. Blood stem cell transplantation helps regenerate the bone marrow's ability to produce blood cells post-chemotherapy. The experimental therapy AB-205 is being studied to prevent or reduce these chemotherapy-related complications, which is vital for improving patient outcomes and minimizing hospitalization and life-threatening risks.