Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)
Key facts
- Where
- Calgary, Halifax, Hamilton, Montreal, Québec, Toronto és Vancouver, KanadaSee the 7 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 18 years old?
Forrás: NCT07509151: ki vehet részt
Where in Kanada
- CalgaryCalgary, KanadaTaking people
- HalifaxHalifax, KanadaTaking people
- HamiltonHamilton, KanadaToborzás még nem indult
- MontrealMontreal, KanadaNo longer taking part
- QuébecQuébec, KanadaNo longer taking part
- TorontoToronto, KanadaTaking people
- VancouverVancouver, KanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07509151
- Record updated
- 2026. október 6.
- Original description
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).Read full original descriptionShow less
A Phase III, Randomised, Open-label, Multicentre, Study of Surovatamig as Consolidation Therapy Versus Observation After First-line Induction Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV (SOUNDTRACK-C1)
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).
Inclusion: 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: Prior CLL/SLL-specific therapies; Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition or prior allogeneic stem cell or solid organ transplant; Major surgical procedure; 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; 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 abnormalities; Known hypersensitivity to surovatamig or any of the excipients of the product; Suspected or confirmed transformation of CLL/SLL to a more aggressive form of lymphoma (ie, Richter's transformation, prolymphocytic leukaemia, or DLBCL); Participants with:.