Study of BKM120 & Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02049541|
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : June 30, 2022
|Condition or disease||Intervention/treatment||Phase|
|Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Splenic Marginal Zone Lymphoma Waldenström Macroglobulinemia||Drug: PI3K inhibitor BKM120 Biological: rituximab Other: Pharmacodynamics Other: Correlative studies||Phase 1|
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of BKM120 and Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma|
|Actual Study Start Date :||July 21, 2014|
|Actual Primary Completion Date :||September 12, 2018|
|Actual Study Completion Date :||April 9, 2019|
Experimental: Treatment (PI3K inhibitor BKM120, rituximab)
Patients receive BKM120 PO daily and rituximab IV. 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. Pharmacodynamic samples from peripheral blood (for those with peripheral blood involvement) and bone marrow aspirate (for all patients) are drawn at baseline. Patients will undergo correlative studies to include bone marrow biopsy at study enrollment, and at the time of complete remission.
Drug: PI3K inhibitor BKM120
Will be supplied to each patient on the first day of each cycle. It will subsequently be self administered by the patient themselves daily on days 1-28 of every 28 day cycle
Given IV (intervenously) on days 2, 8, 15, and 22 of cycle 1, and subsequently on day 1 of cycles 3, 5, 7, 9, and 11.
Pharmacodynamic samples from peripheral blood (for those with peripheral blood involvement) and bone marrow aspirate (for all patients) are drawn at baseline.
Other: Correlative studies
Patients will undergo correlative studies to include bone marrow biopsy at study enrollment, and at the time of complete remission. In addition, patients with peripheral blood involvement at enrollment will have peripheral blood drawn for all planned research correlates.
Other Name: laboratory biomarker analysis
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049541
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Kami Maddocks, MD||Ohio State University Comprehensive Cancer Center|