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

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CXCR4 Waldenstrom’s Macroglobulinemia Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom’s Macroglobulinemia Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom’s Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing LBH589 in Relapsed or Relapsed and Refractory Waldenstrom’s Macroglobulinemia Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia Expression of Ku70/XRCC6 in Waldenström’s Macroglobulinemia Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia Study of VTD in Waldenstrom’s Macroglobulinemia Dasatinib 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Brief Title

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

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 Description

      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.
    

Study Phase

Phase 1

Study Type

Interventional


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

Secondary Outcome

 Incidence of grade 3 or greater adverse events summarized using the NCI CTCAE version 4.0

Condition

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue

Intervention

PI3K inhibitor BKM120

Study Arms / Comparison Groups

 Treatment (PI3K inhibitor BKM120, rituximab)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

18

Start Date

July 21, 2014

Completion Date

December 31, 2020

Primary Completion Date

September 12, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically confirmed indolent B-cell NHL or mantle cell
             lymphoma; acceptable subtypes of indolent B-cell NHL include follicular lymphoma
             (grades 1, 2, or 3a), marginal zone lymphoma, or lymphoplasmacytic
             lymphoma/Waldenstrom's macroglobulinemia; patients with mantle cell lymphoma must have
             a documented t(11;14) or overexpression of cyclin D1 by immunohistochemical
             evaluation; patients with active large cell transformation are not eligible; however,
             patients with a history of large cell transformation are eligible provided that there
             is no current clinical evidence of active transformed lymphoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  At least one prior therapy; prior autologous or allogeneic stem cell transplant is
             allowed; patients may not be on chronic immunosuppressive therapy for
             graft-versus-host disease (GVHD); patients who have received prior treatment with a
             pan-selective PI3K inhibitor are not eligible; however, prior therapy with a selective
             PI3K inhibitor, Bruton's tyrosine kinase inhibitor, or other B-cell receptor targeting
             agents is allowed

          -  Serum creatinine =< 2.0 mg/dL

          -  Total bilirubin =< upper limit of normal

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.0 x upper limit
             of normal

          -  Absolute neutrophil count (ANC) >= 750/mm^3

          -  Platelets >= 50,000/ mm^3

          -  Serum lipase =< upper limit of normal

          -  Serum amylase =< upper limit of normal

          -  International normalized ratio (INR) =< 2.0

          -  Fasting glucose < 120mg/dL

          -  Recovery to =< grade 1 toxicities associated with prior therapy

          -  Negative serum pregnancy test; if, on cycle 1 day 1, greater than 72 hours has elapsed
             since the last negative result, a serum pregnancy test must be repeated and be
             negative on cycle 1 day 1 (C1D1) for the patient to remain eligible

          -  Patient has the ability and willingness to provide informed consent and has signed the
             informed consent document

        Exclusion Criteria:

          -  Pregnant or breast-feeding women and women of childbearing age or men who are
             unwilling to use adequate contraception; females of childbearing age and potential
             (i.e., not surgically sterilized) must use a second form of contraception, including
             total abstinence, intra-uterine device, double-barrier contraception, or other
             non-hormonal form of contraception

          -  Patients with a history of central nervous system involvement by lymphoma

          -  The presence of co-existing medical conditions that would limit compliance with study
             medications, including, but not limited to active infection, active or untreated
             cardiac or pulmonary disease, or malignancy

          -  Patients with significant, symptomatic deterioration of lung function confirmed by
             spirometry, diffusion capacity of carbon monoxide (DLCO), or resting oxygen (O2)
             saturation

          -  Patients with impairment of gastrointestinal function that may alter the absorption of
             BKM120

          -  Patients currently being actively treated or who have been treated within the past 3
             years for an unrelated malignancy (except non-melanoma skin cancer, cervical carcinoma
             in-situ, and low risk prostate cancer)

          -  Patients who have undergone major surgery within 2 weeks prior to study enrollment or
             who have not recovered from a major surgery

          -  Patients with known human immunodeficiency virus (HIV), hepatitis B or hepatitis C
             (active or carriers)

          -  Patients with a fasting blood glucose >= 120 mg/dL (6.7mmol/L); patients with diabetes
             mellitus are eligible if they require oral agents only and have a fasting blood
             glucose =< 120 mg/dL; patients with a history of diabetes mellitus who require daily
             long-acting or mealtime insulin are not eligible; patients who have previously
             required treatment for hyperglycemia due to steroids or other medications are eligible
             as long as they have not required insulin or any other oral agent within 2 months
             prior to study enrollment

          -  Patients who are on chronic steroids for unrelated conditions (i.e. rheumatologic
             conditions) are not eligible if their total daily dose of steroids is >= 10mg
             prednisone

          -  Patients with a known hypersensitivity to BKM120 or its excipients

          -  Patients with active moderate or severe major mood or psychiatric disorder as judged
             by the investigator, primary care physician, counselor, psychiatrist, or as a result
             of the patient's mood assessment questionnaire that may interfere with the ability to
             comply with the trial; in addition, given the prior mood-associated toxicities,
             patients with a history of psychiatric hospitalization within the past 5 years,
             electroconvulsive therapy (ECT) within the past 5 years, or whose psychiatric
             condition has been unstable within 2 months prior to study enrollment requiring
             addition or change of psychotropic medications are not eligible; examples include, but
             are not limited to:

               -  Medically documented history of or active major depressive episode requiring
                  inpatient or intensive outpatient therapy, bipolar disorder (I or II),
                  obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or
                  active ideation, or homicidal ideation (immediate risk of doing harm to others);
                  patients under the care of a primary care physician who are treated with one oral
                  agent and who have not required dose adjustments or new medications within 2
                  months prior to study enrollment and who otherwise meet eligibility requirements
                  may be enrolled

               -  >= Common Terminology for Adverse Events (CTCAE) version 4.0 grade 3 anxiety

               -  Patients meeting the cutoff score of >= 12 in the Patient Health Questionnaire-9
                  (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder-7 (GAD-7) mood
                  scale, respectively, or who select a positive response of "1, 2, or 3" to
                  question number 9 regarding potential for suicidal thoughts in the PHQ-9
                  (independent of the total score of the PHQ-9) are not eligible

          -  Patients with diarrhea >= CTCAE grade 2

          -  Patients with active cardiac disease including any of the following:

               -  Left ventricular ejection fraction < 50% as determined by multi gated acquisition
                  scan (MUGA) scan or echocardiogram

               -  Corrected QT interval (QTc) > 480 msec on screening ECG (using the QTcF formula)

               -  Active angina pectoris

               -  Ventricular arrhythmias except for benign premature ventricular contractions

               -  Supraventricular or nodal arrhythmias or any conduction abnormality requiring a
                  pacemaker or automatic implantable cardioverter defibrillator (AICD)

               -  Valvular disease with documented compromise in cardiac function

               -  Symptomatic pericarditis

               -  Myocardial infarction within the past 6 months

               -  Congestive heart failure (New York Heart Association [NYHA] functional
                  classification III-IV)

          -  Patients who are currently receiving treatment with medications with a known risk to
             prolong the QT interval or inducing Torsades de Pointes and the treatment cannot
             either be discontinued or switched to a different medication prior to study enrollment

          -  Patients who have taken herbal medications and certain fruits within 7 days prior to
             study enrollment are not eligible; herbal medications include, but are not limited to,
             St John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone
             (DHEA), yohimbe, saw palmetto, and ginseng; exclusionary fruits include the cytochrome
             P450 family 3, subfamily A, polypeptide 4 (CYP3A) inhibitors Seville oranges,
             grapefruit, pummelos, or exotic citrus fruits

          -  Patients who are currently treated with drugs known to be moderate and strong
             inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or
             switched to a different medication prior to study enrollment; (please note that
             co-treatment with weak inhibitors of CYP3A is allowed)

          -  Patients who have received oral or IV chemotherapy, targeted anticancer therapy or
             radiation therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C)
             prior to study enrollment

          -  Patients who are currently taking therapeutic doses of warfarin sodium or any other
             Coumadin-derivative anticoagulant; patients who can be safely changed to enoxaparin or
             other non-warfarin derived anti-coagulant and who otherwise meet eligibility
             requirements may be enrolled
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kami Maddocks, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02049541

Organization ID

OSU-13027

Secondary IDs

NCI-2014-00110

Responsible Party

Sponsor-Investigator

Study Sponsor

Kami Maddocks

Collaborators

 Novartis

Study Sponsor

Kami Maddocks, MD, Principal Investigator, Ohio State University Comprehensive Cancer Center


Verification Date

March 2020