Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)
Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV
Investigational drug(s) / intervention(s)
Surovatamig
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
Sex
ALL
Min age
18 Years
Max age
18 Years
Healthy volunteers
No
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 abnormalities.
* 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.
* Known hypersensitivity to surovatamig or any of the excipients of the product.
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
Not Yet Recruiting
Research Site
Fitzroy
Australia
Not Yet Recruiting
Research Site
Heidelberg
Australia
Recruiting
Research Site
Nedlands
Australia
Recruiting
Research Site
Perth
Australia
Not Yet Recruiting
Research Site
Rockingham
Australia
Not Yet Recruiting
Research Site
Calgary
Alberta
Recruiting
Research Site
Vancouver
British Columbia
Suspended
Research Site
Halifax
Nova Scotia
Not Yet Recruiting
Research Site
Hamilton
Ontario
Not Yet Recruiting
Research Site
Toronto
Ontario
Recruiting
Research Site
Montreal
Quebec
Suspended
Research Site
Montreal
Quebec
Not Yet 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
Not Yet 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.
Official registry record
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.
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