Symptoms and General Pathology

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Leukemia, Lymphocytic, Chronic, B-Cell

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Leukemia, B-Cell

Chronic Disease

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Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Richter Syndrome

Patients receive sotrastaurin acetate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

sotrastaurin acetate

pharmacological study

laboratory biomarker analysis

James Blachly, MD

This phase II trial studies how well sotrastaurin acetate works in treating patients with chronic lymphocytic leukemia, small lymphocytic leukemia, prolymphocytic leukemia, or Richter's transformation that has returned or that does not respond to treatment. Sotrastaurin acetate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To determine the objective clinical response rate of AEB071 (sotrastaurin acetate) treatment in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL)/prolymphocytic leukemia (PLL)/Richter's transformation (RT).

SECONDARY OBJECTIVES:

I. To determine the feasibility and tolerability of long-term administration of a fixed dose of AEB071 in patients with relapsed or refractory CLL/SLL/PLL.

II. To examine select downstream pharmacodynamic effects in this population of patients after receiving AEB071 including assessment of the wingless-type MMTV integration site family (WNT) signaling pathway.

III. To determine the feasibility and tolerability of AEB071 treatment in patients with relapsed or refractory mantle cell lymphoma (MCL) as well as to gain preliminary data regarding efficacy in this patient population.

TERTIARY OBJECTIVES:

I. Determine the proportion of patients with select germline and somatic deoxyribonucleic acid (DNA) alterations, including in the B-cell receptor (BCR) pathway.

II. Determine how mutational and transcriptional status in key genes affects response to this therapy and may have affected response to prior therapies.

OUTLINE:

Patients receive sotrastaurin acetate orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then at least every 3 months thereafter.

Sotrastaurin Acetate in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia, Prolymphocytic Leukemia, or Richter's Transformation

A Phase 2 Feasibility Study of Sotrastaurin for Relapsed and Refractory CLL/SLL/PLL/RT

Categories of response for CLL and PLL patients defined according to criteria published by the International Workshop on CLL. Response for SLL/RT patients will be according to revised response criteria for malignant lymphoma. The objective response rate for all evaluable patients in the phase II study will be calculated with an exact 95% binomial confidence interval (assuming that the number of patients who respond is binomially distributed).

For CLL and PLL patients, defined according to the criteria published by the International Workshop on CLL with the modification outlined by Cheson et al. For SLL/RT patients, responses will be according to revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.

Responses are defined according the revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.

For each disease group, frequency and severity of adverse events will be collected and summarized by descriptive statistics.

Number of patients who require dose modifications and/or dose delays will be assessed.

Number of courses started/completed and the reasons for going off-treatment will be assessed.

Markers will be summarized univariately in a quantitative manner and also summarized by clinical outcome group graphically to assess potential patterns and relationships. Changes in BCR signaling over time may be evaluated quantitatively using repeated measures models and graphically with individual time plots or box plots.

Markers will be summarized univariately in a quantitative manner and also summarized by clinical outcome group graphically to assess potential patterns and relationships.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sotrastaurin Acetate in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia, Prolymphocytic Leukemia, or Richter's Transformation	NCT02285244	Prolymphocytic ... Recurrent Mantl... Recurrent Small... Refractory Chro... Richter Syndrom...	sotrastaurin ac... pharmacological... laboratory biom...	18 Years -	Ohio State University Comprehensive Cancer Center
Sotrastaurin Acetate in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia, Prolymphocytic Leukemia, or Richter's Transformation	NCT02285244	Prolymphocytic ... Recurrent Mantl... Recurrent Small... Refractory Chro... Richter Syndrom...	sotrastaurin ac... pharmacological... laboratory biom...	18 Years -	Ohio State University Comprehensive Cancer Center

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