Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)
Recruiting
Phase 3Interventional Study
Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
420 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for patients with Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma who have specific genetic features. Participants will receive a treatment called Surovatamig to see if it helps improve their condition after initial therapy.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma.
I have unmutated Immunoglobulin Heavy Chain Variable (IGHV).
I have completed my first round of treatment.
I have measurable disease.
I have a performance status of 0 to 2.
I have adequate blood, liver, kidney, and heart function.
I am a woman not able to become pregnant or using effective birth control.
I am a man who will use barrier contraception if sexually active.
You may not be able to join if
I have had a transformation of my CLL/SLL to a more aggressive lymphoma.
I have evidence of my leukemia affecting my brain.
I have a history of progressive multifocal leukoencephalopathy.
I have any ongoing or past cancer.
I have an active infection needing treatment.
I have known hypersensitivity to surovatamig.
I have major heart issues.
I have had prior specific treatments for CLL/SLL.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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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) wi…
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.
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