Surovatamig as consolidation therapy after initial treatment for CLL/SLL with unmutated IGHV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 global, randomized, open-label study evaluating subcutaneous Surovatamig as consolidation therapy following first-line therapy in patients with CLL or SLL with unmutated IGHV. The trial has two parts: a dose optimization and safety run-in to establish the recommended Phase III dose, followed by the Phase III portion where participants are randomized 1:1 to receive Surovatamig consolidation or observation. If randomized to consolidation, patients receive RP3D of Surovatamig post-induction therapy; the control arm receives standard care without consolidation. Key eligibility includes confirmed CLL/SLL with unmutated IGHV, measurable disease after first-line therapy, adequate organ function, and appropriate contraception for at-risk participants. Exclusion includes transformation to more aggressive lymphoma and active CNS involvement.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Adelaide, Australia Recruiting
• Research Site
  Heidelberg, Australia Recruiting
• Research Site
  Nedlands, Australia Recruiting
• Research Site
  Perth, Australia Recruiting
• Research Site
  Calgary, Alberta, Canada Recruiting
• Research Site
  Halifax, Nova Scotia, Canada Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.