MedTrace Logo

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

NCT02049541 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-06-30

No results posted yet for this study

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.

Conditions

  • 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

Interventions

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

BIOLOGICAL

rituximab

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.

OTHER

Pharmacodynamics

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.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Kami Maddocks, MD

    lead OTHER

Principal Investigators

  • Kami Maddocks, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-21
Primary Completion
2018-09-12
Completion
2019-04-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02049541 on ClinicalTrials.gov