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(EA9161) A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
Overall Recruitment Status: Active, currently enrolling
 
Official Title
(EA9161) A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
 
Region Sponsors
Colorado
National Cancer Institute (NCI)
 
Acronym KP IRB No.
1401846
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
CCND1/IGHG1 Fusion Negative; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; t(11:14) Negative;
 
Purpose
This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, 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. Giving ibrutinib, obinutuzumab and venetoclax may work better in treating patients with chronic lymphocytic leukemia.
 
Detailed Description
 
Gender Age Limit
Male & Female 18 - 69 years
 
Inclusion Criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
  • Life expectancy of >= 12 months
  • No deletion of 17p13 on cytogenetic analysis by FISH
  • Glomerular filtration rate (GFR) > 40 mL/minute as calculated by the Cockcroft-Gault Formula (obtained =< 14 days prior to registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert's disease. For those with a total bilirubin > 1.5 x ULN, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert's to be diagnosed (obtained =< 14 days prior to registration)
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])/serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3.0 x the institutional ULN (obtained =< 14 days prior to registration)
  • 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
  • Patient must not be vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
  • Patient must be able to receive xanthine oxidase inhibitor or rasburicase for tumor lysis syndrome (TLS) prophylaxis
  • Please reach out to the study team for more eligibility criteria
 
Exclusion Criteria
  • No prior chemotherapy, BTK inhibitor therapy, venetoclax, small molecule signaling inhibitor, or monoclonal anti-body therapy for treatment of CLL or SLL
  • Patients are not eligible if they require treatment with a strong cytochrome P450 (CYP) 3A inhibitor
  • No major surgery within 4 weeks (28 days) of first dose of study drug or minor surgery within 3 days of first dose of study drug
  • No radiation therapy =< 4 weeks prior to registration
  • Please reach out to the study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Chronic Lymphocytic
  • Lymphoma
  • Leukemia
  • Oncology (Adult)
 
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Alex Menter, MD
Contact Information:
- Patty Bourie
-303-649-5281
-Patricia.l.bourie@kp.org
-Lone Tree Medical Offices - Lone Tree


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