RightFit
RecruitingPhase 3

Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe surovatamig is and how well it works when given alone as a shot under the skin after initial treatment. It is for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), two blood cancers, whose cancer has an unchanged IGHV gene.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed CLL or SLL with an unchanged IGHV gene.
  • Meet the study’s rules for initial treatment with a set end date and the response to that treatment.
  • For SLL, have at least one cancer area that can be measured. This does not apply to people in the Phase 3 part whose cancer signs have fully disappeared.
  • Be able to care for yourself and be up and about for at least half of your waking hours.
  • Have blood counts and liver, kidney, and heart function that meet study requirements.
  • Women must be unable to become pregnant or use highly effective birth control.
  • Men planning sex with women who can become pregnant must agree to use barrier birth control, such as condoms.

Who can't join

  • CLL or SLL that may have changed, or has changed, into a faster-growing cancer; or any other current or past cancer.
  • CLL or SLL affecting the brain or spinal cord now or in the past; or a history of or current PML, a serious brain infection.
  • An active or uncontrolled infection needing medicine that treats the whole body, including Epstein-Barr virus; HIV; or chronic or active hepatitis B or C.
  • A history of HLH, a condition in which the immune system causes harmful inflammation.
  • Major heart problems or a major surgery.
  • Prior treatments specifically for CLL or SLL.
  • Need for long-term medicine that weakens the immune system for an active immune or inflammatory illness; or a past donor stem cell or solid organ transplant.
  • A known allergy to surovatamig or any of its ingredients.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (14)

CA

CO

CT

IL

KS

KY

MA

MD

MN

NJ

NY

OH

PA

TX