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RecruitingLast updated: 23 July 2025

CaDAnCe-302: A study for people with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) to investigate how safe and effective a targeted medicine (called BGB-16673) is compared to the researcher's choice of treatmentA Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

CaDAnCe-302

Clinical summary

Summary

You may be eligible for this study if you have chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) and have had previous exposure to treatment with both BTK inhibitors and BCL2 inhibitors.

Eligible participants will be randomly allocated to one of two treatment arms.

In Arm A (Experimental), participants will receive BGB-16673 by itself once a day as an oral tablet.

In Arm B (Active Comparator), participants will receive the Investigator's choice of treatment with either:

  • Idelalisib plus rituximab (people with CLL only), or
  • Bendamustine plus rituximab, or
  • Venetoclax plus rituximab.

Conditions

This trial is treating people with chronic lymphocytic leukaemia or chronic lymphocytic lymphoma who have had prior treatment with both a BTKi and a BCL2i

Eligibility

Inclusion

  1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
  2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
  3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
  4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
  5. Adequate liver function
  6. Adequate blood clotting function

Exclusion

  1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
  3. Known central nervous system involvement
  4. Prior exposure to any BTK protein degraders
  5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
  6. Clinically significant cardiovascular disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

BeiGene

Scientific Title

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

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