Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)
Condition(s) studied
Investigational drug(s) / intervention(s)
Surovatamig: Surovatamig will be administered as a subcutaneous injection.
Study summary
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).
Eligibility
Primary outcome measure(s)
- DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs) — Up to 5 years
To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL/SLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL/SLL participants with uIGHV. - Phase III- Progression Free Survival (PFS) — Until disease progression or death (up to 5 years)
PFS is defined as the time from date of randomisation until disease progression or death due to any cause, whichever occur first based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria, as assessed by independent review committee (IRC). - DOSRI- Number of participants with study intervention discontinuations, dose reductions and dose delays due to AEs — Up to 5 years
To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL/SLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL/SLL participants with uIGHV.
Trial sites (44)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | La Jolla | California | Not Yet Recruiting |
| Research Site | Denver | Colorado | Not Yet Recruiting |
| Research Site | New Haven | Connecticut | Not Yet Recruiting |
| Research Site | Chicago | Illinois | Not Yet Recruiting |
| Research Site | Kansas City | Kansas | Not Yet Recruiting |
| Research Site | Louisville | Kentucky | Not Yet Recruiting |
| Research Site | Bethesda | Maryland | Not Yet Recruiting |
| Research Site | Boston | Massachusetts | Not Yet Recruiting |
| Research Site | Rochester | Minnesota | Not Yet Recruiting |
| Research Site | Basking Ridge | New Jersey | Not Yet Recruiting |
| Research Site | Rochester | New York | Not Yet Recruiting |
| Research Site | Cleveland | Ohio | Not Yet Recruiting |
| Research Site | Pittsburgh | Pennsylvania | Not Yet Recruiting |
| Research Site | Houston | Texas | Not Yet Recruiting |
| Research Site | Adelaide | Australia | Recruiting |
| Research Site | Fitzroy | Australia | Not Yet Recruiting |
| Research Site | Heidelberg | Australia | Recruiting |
| Research Site | Nedlands | Australia | Recruiting |
| Research Site | Perth | Australia | Recruiting |
| Research Site | Rockingham | Australia | Not Yet Recruiting |
| Research Site | Calgary | Alberta | Recruiting |
| Research Site | Vancouver | British Columbia | Suspended |
| Research Site | Halifax | Nova Scotia | Recruiting |
| Research Site | Hamilton | Ontario | Not Yet Recruiting |
| Research Site | Toronto | Ontario | Recruiting |
| Research Site | Montreal | Quebec | Suspended |
| Research Site | Montreal | Quebec | Recruiting |
| Research Site | Québec | Quebec | Suspended |
| Research Site | Adapazarı | Turkey (Türkiye) | Recruiting |
| Research Site | Antalya | Turkey (Türkiye) | Recruiting |
| Research Site | Istanbul | Turkey (Türkiye) | Not Yet Recruiting |
| Research Site | Istanbul | Turkey (Türkiye) | Recruiting |
| Research Site | Istanbul | Turkey (Türkiye) | Recruiting |
| Research Site | Kocaeli | Turkey (Türkiye) | Recruiting |
| Research Site | Mezitli | Turkey (Türkiye) | Recruiting |
| Research Site | Edinburgh | United Kingdom | Recruiting |
| Research Site | Hampshire | United Kingdom | Recruiting |
| Research Site | Leeds | United Kingdom | Not Yet Recruiting |
| Research Site | London | United Kingdom | Recruiting |
| Research Site | London | United Kingdom | Recruiting |
+ 4 more sites — see the full list on the official registry below.
More AstraZeneca trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07509151 on ClinicalTrials.gov ↗ ← All trials in the UK