Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma

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Macroglobulinemia and in IgM-MGUS Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia Perifosine in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia Randomised Trial in Waldenstrom’s Macroglobulinaemia A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom’s Macroglobulinemia (WM) Pomalidomide, Dexamethasone and Rituximab in Waldenstrom’s Macroglobulinemia Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia Study of Epratuzumab (hLL2) in Patients With Waldenstrom’s Macroglobulinemia A Study for Patients That Have Been Previously Been Treated in Waldenstrom’s Macroglobulinemia or Multiple Myeloma Ibrutinib With Rituximab in Adults With Waldenström’s Macroglobulinemia Oblimersen in Treating Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström’s Macroglobulinaemia An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia Simvastatin in Waldenstrom’s Macroglobulinemia Ibrutinib (PCI-32765) in Waldenstrom’s Macroglobulinemia Carfilzomib, Rituximab and Dexamethasone in Waldenstrom’s Macroglobulinemia Thalidomide and Rituximab in Waldenstrom’s Macroglobulinemia Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia’s Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated 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 In Waldenström Macroglobulinemia The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom’s Macroglobulinemia Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia Efficacy of First Line B-RI for Treatment Naive Waldenström’s Macroglobulinemia Sildenafil Citrate in Waldenstrom’s Macroglobulinemia Bortezomib (Velcade) in Waldenstrom’s Macroglobulinemia Phase II Study of Campath-1H Antibody to Treat Waldenstrom’s Macroglobulinemia

Brief Title

Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma

Official Title

A Window Study of Ixazomib in Untreated Indolent B-NHL

Brief Summary

      This phase II trial studies how well ixazomib citrate and rituximab work in treating patients
      with B-cell non-Hodgkin lymphoma that grows slowly (indolent). Ixazomib citrate may stop the
      growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a
      monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
      Giving ixazomib citrate together with rituximab may work better in treating indolent B-cell
      non-Hodgkin lymphoma.
    

Detailed Description

      OUTLINE:

      Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every
      28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6
      cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once
      weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or
      unacceptable toxicity.

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

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall response rate (ORR) (complete response [CR] + partial response [PR]) in patients with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)

Secondary Outcome

 Duration of response (DOR)

Condition

Chronic Lymphocytic Leukemia

Intervention

Ixazomib Citrate

Study Arms / Comparison Groups

 Treatment (ixazomib citrate, rituximab)
Description:  Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity.

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

33

Start Date

May 19, 2016

Completion Date

January 6, 2025

Primary Completion Date

January 6, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Voluntary written consent must be given before performance of any study related
             procedure not part of standard medical care, with the understanding that consent may
             be withdrawn by the patient at any time without prejudice to future medical care

          -  Female patients who:

               -  Are postmenopausal for at least 1 year before the screening visit, OR

               -  Are surgically sterile, OR

               -  If they are of childbearing potential, agree to practice 2 effective methods of
                  contraception, at the same time, from the time of signing the informed consent
                  form through 90 days after the last dose of study drug, OR

               -  Agree to practice true abstinence when this is in line with the preferred and
                  usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation,
                  symptothermal, post-ovulation methods] and withdrawal are not acceptable methods
                  of contraception)

          -  Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree
             to one of the following:

               -  Agree to practice effective barrier contraception during the entire study
                  treatment period and through 90 days after the last dose of study drug, OR

               -  Agree to practice true abstinence when this is in line with the preferred and
                  usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation,
                  symptothermal, post-ovulation methods] and withdrawal are not acceptable methods
                  of contraception)

          -  Patients must have a diagnosis of one of the following B-NHL malignancies: chronic
             lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), follicular lymphoma
             (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or Waldenstrom
             macroglobulinemia (WM)/ lymphoplasmacytic lymphoma (LPL); patients with mucosa
             associated lymphoid tissue (MALT) subtype of MZL may have relapsed or refractory
             disease after a course of antibiotic therapy; otherwise, patients will not have
             received standard systemic treatment for their B-NHL before the time of study
             enrollment; standard systemic therapy is defined by including any of the following
             agents, representing a comprehensive list of recommended front-line agents used in the
             treatment of B-NHL: cytotoxic chemotherapies (bendamustine, cyclophosphamide,
             doxorubicin, vincristine, chlorambucil, cytarabine, gemcitabine, platinum drugs,
             etoposide); anti-CD20 antibodies (obinutuzumab, ofatumumab, rituximab); lenalidomide;
             ibritumomab tiuxetan; proteasome inhibitors (bortezomib, carfilzomib); tyrosine kinase
             inhibitors (ibrutinib, acalabrutinib, idelalisib); alemtuzumab; corticosteroids unless
             given for an indication other than treating the B-NHL; or other therapy as determined
             by the principal investigator (PI)

               -  Disease: CLL/SLL; Criteria for diagnosis: histopathologic or flow cytometric
                  confirmation

               -  Disease: FL; Criteria for diagnosis: histopathologic confirmation

               -  Disease: MZL; Criteria for diagnosis: histopathologic confirmation

               -  Disease: MCL; Criteria for diagnosis: histopathologic confirmation

               -  Disease: WM/LPL; Criteria for diagnosis: Per World Health Organization (WHO)
                  criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance
             status 0, 1, or 2

          -  Absolute neutrophil count (ANC) >= 1,000/mm^3 or >= 500/mm^3 if neutropenia is
             attributed to B-NHL (involvement of bone marrow) without growth factor support

          -  Platelet count >= 100,000/mm^3 or >= 75,000/mm^3 if thrombocytopenia is attributed to
             B-NHL (involvement of bone marrow or due to splenomegaly or immune thrombocytopenic
             purpura); platelet transfusions to help patients meet eligibility criteria are not
             allowed within 3 days before study enrollment

          -  Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN

          -  Calculated creatinine clearance >= 30 mL/min

          -  Patients are required to meet criteria for initiation of therapy for their B-NHL
             according to published guidelines by the National Comprehensive Cancer Network (NCCN)

          -  Patients must have measurable disease defined by at least one of the following
             criteria:

               -  Lesions greater than 1.5 cm that can be accurately measured in two dimensions by
                  computed tomography (CT) (preferred), or magnetic resonance imaging (MRI), and
                  are not included in any prior field of radiation given to treat B-NHL

               -  In patients with CLL, circulating lymphocytes >= 5,000 / mm^3

               -  In patients with WM/LPL, measurable serum monoclonal immunoglobulin M (IgM)

        Exclusion Criteria:

          -  Female patients who are lactating or have a positive serum pregnancy test during the
             screening period

          -  Major surgery within 14 days before enrollment

          -  Known central nervous system involvement

          -  Infection requiring systemic antibiotic therapy or other serious infection within 14
             days before study enrollment

          -  Evidence of current uncontrolled cardiovascular conditions, including uncontrolled
             hypertension, cardiac arrhythmias, or congestive heart failure, and unstable angina or
             myocardial infarction within the past 6 months

          -  Systemic treatment, within 14 days before the first dose of ixazomib, with strong
             inhibitors of cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2)
             (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of cytochrome P450, family
             3, subfamily A (CYP3A) (clarithromycin, telithromycin, itraconazole, voriconazole,
             ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin,
             rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of ginkgo
             biloba or St. John's wort

          -  Known ongoing or known active systemic infection, known active hepatitis B or C virus
             infection, or known human immunodeficiency virus (HIV) positive

          -  Any serious medical or psychiatric illness that could, in the investigator's opinion,
             potentially interfere with the completion of treatment according to this protocol

          -  Known allergy to ixazomib, its analogues, or excipients in the various formulations of
             ixazomib

          -  Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral
             absorption or tolerance of ixazomib including difficulty swallowing

          -  Diagnosed or treated for another malignancy within 2 years before study enrollment or
             previously diagnosed (> 2 years before study enrollment) with another malignancy and
             have any evidence of residual disease that is symptomatic or requiring treatment;
             (this may be waived at the discretion of the principal investigator for patients in
             complete remission if they have not received systemic therapy); patients with
             non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they
             have undergone complete resection

          -  Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical
             examination during the screening period

          -  Participation in other clinical trials with other investigational agents not included
             in this trial, within 21 days of the start of this trial and throughout the duration
             of this trial

          -  Patients may not have impending organ compromise from disease as assessed by their
             treating physician

          -  Prior treatment of B-NHL with radiation therapy, non-standard systemic therapy, or
             antibiotics (in cases of MZL) within 21 days of the first dose of ixazomib
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ajay K. Gopal, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02339922

Organization ID

9571

Secondary IDs

NCI-2016-00401

Responsible Party

Sponsor

Study Sponsor

University of Washington

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Ajay K. Gopal, Principal Investigator, Fred Hutch/University of Washington Cancer Consortium


Verification Date

April 2021