CompletedPhase 2

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

United States42 participantsStarted 2016-01-12

Plain-language summary

This randomized phase II trial studies how well ibrutinib works when given together with vaccine therapies in treating patients without clinical signs or indications that raise the possibility of a particular disorder or dysfunction (asymptomatic) who have high-risk 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. Vaccines, such as pneumococcal 13-valent conjugate vaccine, trivalent influenza vaccine, and diphtheria toxoid/tetanus toxoid/acellular pertussis vaccine adsorbed, may help the body build an effective immune response to kill cancer cells. Giving ibrutinib together with vaccine therapies may be a better treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have histologically identified chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as defined by the World Health Organization (WHO) classification of hematopoietic neoplasms * CLL/SLL cells must demonstrate one or more of the following high-risk genomic features: * Del17p13.1(tumor protein p53 \[TP53\]) as detected by fluorescence in-situ hybridization (FISH) * Del11q22.3 ataxia telangiectasia mutated (ATM) as detected by FISH * Complex karyotype (\>= 3 cytogenetic abnormalities on stimulated karyotype) * Unmutated immunoglobulin variable region heavy chain (IgVH) ( \>= 98% sequence homology compared with germline sequence) * Zeta-chain (TCR) associated protein kinase 70kDa (ZAP-70) gene promoter hypomethylation \< 20% * No prior therapy for CLL/SLL, including chemotherapy and/or radiotherapy is allowed * Estimated life expectancy of greater than 24 months * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Total bilirubin =\< 1.5X upper limit of normal (ULN) unless secondary to Gilbert's disease * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5X institutional upper limit of normal * Serum creatinine =\< 2 md/dL or estimated creatinine clearance (CrCl) \> 50ml/min/body surface area (BSA) * Prothrombin time (PT)/international normalized ratio (INR) \< 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time \[aPTT\]) \…

What they're measuring

Proportion of patients who are alive and progression-free

Timeframe: At 2 years from the date of the first ibrutinib administration

Trial details

NCT IDNCT02518555

SponsorJennifer Woyach

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-15