Find Chronic B-Cell Leukemia (CBCL) Clinical Trials Near You
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)
Status: Recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
United States
California
Research Site
NOT_YET_RECRUITING
La Jolla
Colorado
Research Site
NOT_YET_RECRUITING
Denver
Connecticut
Research Site
NOT_YET_RECRUITING
New Haven
Illinois
Research Site
NOT_YET_RECRUITING
Chicago
Kansas
Research Site
NOT_YET_RECRUITING
Kansas City
Kentucky
Research Site
NOT_YET_RECRUITING
Louisville
Massachusetts
Research Site
NOT_YET_RECRUITING
Boston
Maryland
Research Site
NOT_YET_RECRUITING
Bethesda
Minnesota
Research Site
NOT_YET_RECRUITING
Rochester
New Jersey
Research Site
NOT_YET_RECRUITING
Basking Ridge
New York
Research Site
NOT_YET_RECRUITING
Rochester
Ohio
Research Site
NOT_YET_RECRUITING
Cleveland
Pennsylvania
Research Site
NOT_YET_RECRUITING
Pittsburgh
Texas
Research Site
NOT_YET_RECRUITING
Houston
Other Locations
Australia
Research Site
NOT_YET_RECRUITING
Adelaide
Research Site
NOT_YET_RECRUITING
Fitzroy
Research Site
RECRUITING
Heidelberg
Research Site
RECRUITING
Nedlands
Research Site
NOT_YET_RECRUITING
Perth
Research Site
NOT_YET_RECRUITING
Rockingham
Canada
Research Site
RECRUITING
Calgary
Research Site
NOT_YET_RECRUITING
Halifax
Research Site
NOT_YET_RECRUITING
Hamilton
Research Site
NOT_YET_RECRUITING
Montreal
Research Site
SUSPENDED
Montreal
Research Site
SUSPENDED
Québec
Research Site
RECRUITING
Toronto
Research Site
SUSPENDED
Vancouver
Turkey
Research Site
RECRUITING
Adapazarı
Research Site
RECRUITING
Antalya
Research Site
RECRUITING
Istanbul
Research Site
NOT_YET_RECRUITING
Istanbul
Research Site
RECRUITING
Istanbul
Research Site
RECRUITING
Kocaeli
Research Site
RECRUITING
Mezitli
United Kingdom
Research Site
RECRUITING
Edinburgh
Research Site
NOT_YET_RECRUITING
Hampshire
Research Site
NOT_YET_RECRUITING
Leeds
Research Site
RECRUITING
London
Research Site
RECRUITING
London
Research Site
RECRUITING
Manchester
Research Site
RECRUITING
Nottingham
Research Site
RECRUITING
Oxford
Research Site
NOT_YET_RECRUITING
Sutton
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2026-05-05
Estimated Completion Date:2032-04-05
Participants
Target number of participants:420
Treatments
Experimental: Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1
Participants will receive Surovatamig Dose 1 subcutaneously (SC) for 6 cycles (each cycle is 28 days in length).
Experimental: DOSRI-Surovatamig Dose 2
Participants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length).
Experimental: Phase III-Arm A: Surovatamig SC
Participants will receive Surovatamig at RP3D subcutaneously for 6 cycles (each cycle is 28 days in length).
No_intervention: Phase III-Arm B: Observation
Participants will undergo observation for 24 weeks.