Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small … (NCT07509151) | Clinical Trial Compass
RecruitingPhase 3
Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)
The purpose of this study is to evaluate the therapeutic benefit and safety of subcutaneous (SC) Surovatamig monotherapy as consolidation therapy in patients with Chronic Lymphocytic Leukaemia (CLL)/ Small Lymphocytic Lymphoma (SLL) with unmutated IGHV (uIGHV).
Who can participate
Age range
18 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented diagnosis of CLL/SLL with genomic features defined by unmutated IGHV.
* Treatment received and response at the end of 1L (first-line) finite therapy.
* Participants with SLL (except those in CR in Phase III part) must have measurable disease (nodal or extranodal) with at least one measurable target lesion.
* ECOG performance status of 0 to 2.
* Adequate haematologic, liver, renal and cardiac function.
* Female participants: must be either women not of childbearing potential or must use a highly effective form of contraception.
* Male participants who intend to be sexually active with females of childbearing potential must agree to use barrier contraception (eg, condoms).
Exclusion Criteria:
* Suspected or confirmed transformation of CLL/SLL to a more aggressive form of lymphoma (ie, Richter's transformation, prolymphocytic leukaemia, or DLBCL).
* Evidence of active or history of Central Nervous System (CNS) involvement by CLL/SLL.
* History of or ongoing confirmed progressive multifocal leukoencephalopathy.
* Participants who have any concurrent or history of malignancy.
* Participants with:
* Active or uncontrolled infection (including Epstein-Barr virus-EBV) requiring systemic therapy.
* Participants with known history of Heamophagocytic lymphohistiocytosis (HLH).
* Human Immunodeficiency Virus (HIV) infection, or participants with chronic or active infection with Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
* Major cardiac abnorma…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 5 years
2
Phase III- Progression Free Survival (PFS)
Timeframe: Until disease progression or death (up to 5 years)
3
DOSRI- Number of participants with study intervention discontinuations, dose reductions and dose delays due to AEs