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New treatment option for Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With...
Official title Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)
ClinicalTrials.gov ID: NCT07509151
What this study is testing
What is Surovatamig?
Surovatamig is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic lymphocytic leukaemia or small lymphocytic lymphoma with unmutated ighv.
Also referred to as TNB-486, AZD0486.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 18
You may be able to join if
- 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...
- ECOG performance status of 0 to 2.
- Adequate haematologic, liver, renal and cardiac function.
You likely can't join if
- Suspected or confirmed transformation of CLL/SLL to a more aggressive form of lymphoma (ie, Richter's transformation, prolymphocytic leukaemia, or...
- 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.
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, Australia
- Fitzroy, Australia
- Heidelberg, Australia
- Nedlands, Australia
- Perth, Australia
- Rockingham, Australia
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Adapazarı, Turkey (Türkiye)
- Antalya, Turkey (Türkiye)
- Istanbul, Turkey (Türkiye)
- Kocaeli, Turkey (Türkiye)
- Mezitli, Turkey (Türkiye)
- Edinburgh, United Kingdom
- Hampshire, United Kingdom
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, Australia; Fitzroy, Australia; Heidelberg, Australia; Nedlands, Australia; Perth, Australia; Rockingham, Australia and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.