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Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Recurrent Small Lymphocytic Lymphoma Clinical Trial

Official title:
Acalabrutinib in Combination With Venetoclax (AV) for Previously Treated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Clinical Trial Summary

This phase II trial is to evaluate the effects of acalabrutinib in combination with venetoclax in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that does not respond to treatment (refractory) or that has come back (recurrent). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Given acalabrutinib and venetoclax may kill more cancer cells.

Clinical Trial Description

OUTLINE: Patients receive acalabrutinib orally (PO) twice a day (BID) and venetoclax PO once daily (QD) on days 1-28. Patients receive acalabrutinib alone for the first three 28 day cycles. Venetoclax is added beginning with Cycle 4. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed-up every 12 weeks and annually for 10 years. ;

Study Design

Related Conditions & MeSH terms

  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Recurrence
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Small Lymphocytic Lymphoma
Clinical Trial Details
NCT number NCT04941716
Study type Interventional
Source Fred Hutchinson Cancer Center
Contact Mazyar Shadman
Phone 206-667-5467
Email mshadman@fredhutch.org
Status Recruiting
Phase Phase 2
Start date May 31, 2023
Completion date August 10, 2031
View Details
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