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Closed (no longer recruiting)Last updated: 28 March 2024

Captivate: This phase II trial is combining a targetted therapy (ibrutinib) with a chemotherapy drug (venetoclax) for the treatment of Chronic Lymphocytic Leukaemia and Small Lymphocytic LeukaemiaPhase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Clinical summary

Summary

This study is to determine the clinical minimum residual disease (MRD) response with the combination of ibrutinib plus venetoclax in subjects with treatment-naive chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma

Conditions

This trial is treating patients with Chronic Lymphocytic Leukaemia, Chronic Lymphocytic Leukaemia.

Cancer

Blood Cancers Haematological

Age

People18 - 69

Phase

II

Trial Acronym

Captivate

More information

Trial Identifiers

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Trial sponsor

Pharmacyclics

Scientific Title

Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Eligibility

Inclusion

  • Diagnosis of CLL/SLL that meets 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria (Hallek et al), with active disease meeting at least 1 IWCLL criteria for requiring treatment.
  • Measurable nodal disease by computed tomography (CT)
  • Adequate hepatic, and renal function
  • Adequate hematologic function
  • absolute neutrophil count >750/µL
  • platelet count >30,000 /μL
  • hemoglobin >8.0 g/dL

Exclusion

  • Any prior therapy used for treatment of CLL/SLL
  • Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for tumor lysis syndrome (TLS)

Exclusion

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