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A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)
Overall Recruitment Status: Enrollment complete
 
Official Title
A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)
 
Region Sponsors
California - Northern
National Cancer Institute (NCI)
 
Acronym NCT No.
NCT02048813
 
Study Type Phase
Clinical Trial
Phase III
 
Purpose
This phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
 
Detailed Description
 
 
 
Inclusion Criteria
  • Diagnosis of CLL according to the National Cancer Institute (NCI)/Internal Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria or small lymphocytic lymphoma (SLL) according to the World Health Organization (WHO) criteria
  • this includes previous documentation of: Biopsy-proven small lymphocytic lymphoma or Diagnosis of CLL according to the NCI/IWCLL criteria as evidenced by all of the following: Peripheral blood lymphocyte count of greater than 5 x 10^9/L Immunophenotype consistent with CLL defined as: The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation [CD]19, CD20 [typically dim expression], or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc) Clonality as evidenced by kappa or lambda light chain restriction (typically dim immunoglobulin expression) Negative FISH analysis for t(11
  • 14)(immunoglobulin heavy locus [IgH]/cyclin D1 [CCND1]) on peripheral blood or tissue biopsy (e.g. marrow aspirate) or negative immunohistochemical stains for cyclin D1 staining on involved tissue biopsy (e.g. marrow aspirate or lymph node biopsy)
  • ECOG performance status between 0-2
  • Life expectancy of >= 12 months
  • Ability to tolerate FCR based therapy
 
Exclusion Criteria
  • No prior chemotherapy, Bruton's tyrosine kinase (BTK) inhibitor therapy, or monoclonal anti-body therapy for treatment of CLL or SLL
  • No deletion of 17p13 on cytogenetic analysis by FISH
  • No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment
  • patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation
  • No current use of corticosteroids
  • EXCEPTION: low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical condition (e.g. chronic adrenal insufficiency) is permitted
  • No previous use of corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL
  • prior use of corticosteroids for reasons other than treatment of autoimmune complications is allowed
 
Keywords and/or Specific Medical Conditions
  • Hematology
  • Oncology (Adult)
 
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
 
Clinical Area
  • Hematology
  • Oncology (Adult)


Principal Investigator:
Tatjana Kolevska
Contact Information:
- Desiree S Goldstein
-CTPCollaborate@kp.org
-Central Valley-Manteca


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