Surovatamig for Chronic Lymphocytic Leukaemia
(SOUNDTRACK-C1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Surovatamig for individuals with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who possess a specific genetic marker known as unmutated IGHV. The study aims to determine if Surovatamig, administered as a subcutaneous injection, is safe and effective as a follow-up treatment after initial therapy. Participants will either receive varying doses of Surovatamig or be observed for a period. This trial suits those diagnosed with CLL or SLL, who have completed their first round of treatment, and have the genetic feature unmutated IGHV. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that Surovatamig is likely to be safe for humans?
Research has shown that Surovatamig has been tested in people before. In these studies, the treatment proved generally safe, with most participants experiencing no serious side effects. The most common side effects were mild, such as redness or swelling at the injection site, which is typical for subcutaneous treatments.
Another study on its use for different conditions also found Surovatamig to be mostly safe, with serious side effects being rare. This suggests that Surovatamig might be well-tolerated by people with Chronic Lymphocytic Leukemia.
The current trial is in a later stage, indicating that the treatment has already demonstrated a good level of safety in earlier tests. While all medicines can have side effects, Surovatamig has been deemed safe enough for testing in more people.12345Why do researchers think this study treatment might be promising for CLL?
Researchers are excited about Surovatamig for chronic lymphocytic leukemia (CLL) because it offers a new approach to treatment. Unlike traditional therapies such as chemotherapy and targeted drugs like ibrutinib or venetoclax, Surovatamig is administered subcutaneously, which can be more convenient for patients compared to intravenous or oral options. Additionally, it works by a novel mechanism that targets specific pathways involved in CLL, potentially leading to more effective control of the disease. This unique delivery method and mechanism of action make Surovatamig a promising option that could improve patient outcomes.
What evidence suggests that Surovatamig could be an effective treatment for Chronic Lymphocytic Leukaemia?
Research has shown that surovatamig may help treat certain blood cancers. One study found that patients who had already received CD19-targeted therapy had a 67% response rate with one dose of surovatamig and a 100% response rate with a higher dose. Another study on patients with B-cell non-Hodgkin lymphoma reported a 96% response rate, with 85% of patients achieving complete remission. This trial will evaluate different doses of surovatamig for patients with Chronic Lymphocytic Leukemia (CLL), including those with unmutated IGHV, to gather specific data on its effectiveness for CLL.23456
Are You a Good Fit for This Trial?
This trial is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have a specific genetic marker called unmutated IGHV, have finished their first round of treatment, are in good general health, and agree to use effective birth control.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Optimisation and Safety Run-in
Participants receive Surovatamig at two dose levels to determine the recommended Phase III dose
Phase III - Treatment
Participants receive Surovatamig at the recommended Phase III dose as consolidation therapy
Phase III - Observation
Participants undergo observation without active treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Surovatamig
Trial Overview
The study tests Surovatamig given as an injection under the skin by itself (monotherapy), used after initial treatment to help keep CLL/SLL from coming back. All participants receive this therapy.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Participants will receive Surovatamig at RP3D subcutaneously for 6 cycles (each cycle is 28 days in length).
Participants will receive Surovatamig Dose 1 subcutaneously (SC) for 6 cycles (each cycle is 28 days in length).
Participants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length).
Participants will undergo observation for 24 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Citations
A Study of AZD0486 Monotherapy or in Combination with ...
The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other ...
Astra goes subcutaneous in its Merck race | ApexOnco
The primary efficacy endpoint will be progression-free survival. Surovatamig doesn't appear to have produced clinical data yet in CLL, although ...
Surovatamig for Chronic Lymphocytic Leukaemia · Info for ...
The purpose of this study is to evaluate the therapeutic benefit and safety of subcutaneous (SC) Surovatamig monotherapy as consolidation therapy in ...
Systematic review of real-world data on the effectiveness ...
Results: Ibrutinib (IBR) demonstrated consistent effectiveness in multiple RWD studies, with 12- and 24-month OS rates of 87-100% and 78-100%, ...
Advancing Immunotherapy in Chronic Lymphocytic Leukemia
Based on current clinical experience, BTKi and BCL2i are highly effective. Although they do not cure the disease, they provide most patients with significantly ...
6.
ctv.veeva.com
ctv.veeva.com/study/surovatamig-as-consolidation-therapy-in-participants-with-chronic-lymphocytic-leukaemia-or-small-lymSurovatamig as Consolidation Therapy in Participants With ...
The purpose of this study is to evaluate the therapeutic benefit and safety of subcutaneous (SC) Surovatamig monotherapy as consolidation ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.