Leukemia, Lymphocytic, Chronic, B-Cell

arsenic trioxide combined with ibrutinib in CLL

Ibrutinib combined with As2O3

ibrutinib

Combination of Ibrutinib and As2O3 in the Treatment of CLL

Peking University People's Hospital

Beijing Hospital

Patients receive a run-up cycle of ibrutinib PO daily on days 1-28. Patients then receive ibrutinib PO and lenalidomide PO daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients who have achieved CR/CRi, nodular PR, partial remission with persistent lymphocytosis, partial remission, or who have stable disease discontinue lenalidomide and continue ibrutinib.

Recurrent B-Cell Prolymphocytic Leukemia

Recurrent Chronic Lymphocytic Leukemia

Recurrent Small Lymphocytic Lymphoma

Refractory B-Cell Prolymphocytic Leukemia

Refractory Chronic Lymphocytic Leukemia

Refractory Small Lymphocytic Lymphoma

Ibrutinib

Lenalidomide

Stanford Cancer Institute Palo Alto

University of Colorado Hospital

Ohio State University Comprehensive Cancer Center

Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Dose Escalation Study of Ibrutinib With Lenalidomide for Relapsed and Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Defined as the highest dose in which less than or equal to 1/6 patients have dose limiting toxicity. Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All patient safety information collected will be summarized using descriptive statistics (number of non-missing values, mean, median, standard deviation, minimum and maximum) for continuous variables and counts and percentages for categorical variables, where applicable.

Response rates will be calculated based on all the intention-to-treat subjects and reported along with its exact 95% confidence interval.

Remission/response duration is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Response duration will be calculated, and the mean, median, minimum, and maximum values will be reported.

The impact of lenalidomide on pharmacokinetics of ibrutinib will be evaluated by comparisons of non-compartmental AUCs for ibrutinib on cycle 0, day 8 versus cycle 2, day 1.

The impact of lenalidomide on ibrutinib binding to Bruton's tyrosine kinase and interleukin-2 inducible kinase will be evaluated, and the mechanistic interactions between the two agents will be investigated.

Defined as the ratio between the signal pre-dose and the signal post-dose. More than 95% occupancy is defined as full occupancy.

Comparison of Rho GTPase expression and activation levels, as well as migration before and after treatment with lenalidomide, will be performed using a paired Student t test. The predictive power of the clinical and laboratory values measured for purposes of biomarker discover will be assessed by a multiple comparison analysis of variance test.

lymphocytosis/tyrosine

Combination of Ibrutinib and As2O3 in the Treatment of CLL

Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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