Clinical Trial: Study of BKM120 & Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase I Study of BKM120 and Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma

Brief Summary: This phase I clinical trial studies the side effects and the best dose of phosphatidylinositol-3-kinase (PI3K) inhibitor BKM120 when given together with rituximab in treating patients with relapsed or refractory low-grade B-cell lymphoma. PI3K inhibitor BKM120 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving PI3K inhibitor BKM120 with rituximab may be an effective treatment for B-cell lymphoma.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of combined rituximab and BKM120 (PI3k inhibitor BKM120) in patients with previously treated indolent non-Hodgkin lymphoma (NHL) (including follicular lymphoma (FL), marginal zone lymphoma, and lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia), and mantle cell lymphoma (MCL).

SECONDARY OBJECTIVES:

I. To determine specific toxicities associated with combined BKM120 and rituximab.

II. Evaluate for efficacy of BKM120 in combination with rituximab in these diseases.

OUTLINE: This is a dose-escalation study of PI3K inhibitor BKM120.

Patients receive PI3K inhibitor BKM120 orally (PO) daily on days 1-28 and rituximab intravenously (IV) on days 2, 8, 15, and 22 of course 1 and on day 1 of courses 3, 5, 7, 9, and 11. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with asymptomatic progression may continue treatment for up to 12 months.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.


Sponsor: Kami Maddocks

Current Primary Outcome: MTD defined as the dose level at which no more than one of 6 patients experiences a DLT summarized using the National Cancer Institute (NCI) CTCAE version 4.0 [ Time Frame: 28 days ]

Summarized and tabulated by dose level.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of grade 3 or greater adverse events summarized using the NCI CTCAE version 4.0 [ Time Frame: Up to 5 years ]
    Summarized and tabulated by dose-level.
  • Overall response rate (ORR) evaluated by computed tomography (CT) or positron emission tomography (PET)/CT [ Time Frame: Up to 5 years ]
  • Change in correlative markers in blood, bone marrow and tumor tissue [ Time Frame: Baseline to up to 5 years ]
    Explored using graphical analyses as well as summarized quantitatively.


Original Secondary Outcome: Same as current

Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: January 28, 2014
Date Started: July 2014
Date Completion:
Last Updated: October 18, 2016
Last Verified: October 2016