Testing the Addition of a New Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom’s Macroglobulinemia/Lymphoplasmacytic Lymphoma

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Combination With Ibrutinib in Waldenström’s Macroglobulinemia Efficacy of First Line DRC +/- Bortezomib for Patients With Waldenström’s Macroglobulinemia Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia Rituximab and Ibrutinib (RI) Versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as Initial Therapy for Waldenström’s Macroglobulinaemia Extension Study of IMO-8400 in Patients With Waldenström’s Macroglobulinemia Who Completed Study 8400-401 DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom’s Macroglobulinemia Patients Study of Safety,Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom’s Macroglobulinemia Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström’s Macroglobulinemia (WM) Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström’s 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

Testing the Addition of a New Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma

Official Title

A Phase II Randomized Study of Ibrutinib and Rituximab With or Without Venetoclax in Previously Untreated Waldenstrom's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)

Brief Summary

      This phase II trial studies the effects of ibrutinib and rituximab with or without venetoclax
      in treating patients with previously untreated Waldenstrom's
      macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib 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. Venetoclax may stop
      the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival.
      Giving venetoclax with ibrutinib and rituximab with may work better in treating patients with
      previously untreated Waldenstrom's macroglobulinemia than ibrutinib and rituximab alone.
    

Detailed Description

      PRIMARY OBJECTIVE:

      I. To compare the rate of complete response (CR) in previously untreated participants with
      Waldenstrom's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) who are treated upfront
      with ibrutinib, rituximab and venetoclax (IRV) versus (vs.) ibrutinib and rituximab (IR)
      regimen.

      SECONDARY OBJECTIVES:

      I. To compare overall response rates (ORR) in WM participants treated upfront with IRV vs.
      those treated with IR.

      II. To compare progression free survival (PFS), time to next treatment, duration of response
      in WM participants treated upfront with IRV vs. those treated with IR.

      III. To compare the rate of very good partial response (VGPR) or better in WM participants
      treated upfront with IRV vs. those treated with IR.

      IV. To evaluate the safety of the IRV regimen as compared to IR regimen in participants with
      WM.

      V. To evaluate the time to CR in WM participants treated upfront with IRV and those treated
      with IR.

      VI. To evaluate the ORR in participants who progress on treatment with IR and are crossed
      over to treatment with IRV.

      VII. To compare overall survival (OS) in WM participants treated upfront with IRV vs. those
      treated with IR.

      BANK OBJECTIVE:

      I. To bank specimens for future correlative studies.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28 of cycles 1-24 and
      rituximab intravenously (IV) on days 1, 8, 15, and 22 of cycles 1 and 5. Treatment repeats
      every 28 days for up to 24 cycles in the absence of disease progression or unacceptable
      toxicity. Patients with progressive disease during Arm I may receive ibrutinib, rituximab,
      and venetoclax as in Arm II for up to an additional 24 cycles.

      ARM II: Patients receive ibrutinib PO QD on days 1-28 of cycles 1-24, rituximab IV on days 1,
      8, 15, and 22 of cycles 1 and 5, and venetoclax PO QD on days 1-28 of cycles 2-24. Treatment
      repeats every 28 days for up to 24 cycles in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months for 2 years and
      then every 6 months for up to 5 years.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Complete response rate

Secondary Outcome

 Progression-free survival

Condition

Lymphoplasmacytic Lymphoma

Intervention

Ibrutinib

Study Arms / Comparison Groups

 Arm I (ibrutinib, rituximab)
Description:  Patients receive ibrutinib PO QD on days 1-28 of cycles 1-24 and rituximab IV on days 1, 8, 15, and 22 of cycles 1 and 5. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with progressive disease during Arm I may receive ibrutinib, rituximab, and venetoclax as in Arm II for up to an additional 24 cycles.

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

68

Start Date

June 24, 2021

Completion Date

April 30, 2023

Primary Completion Date

April 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have had a confirmed diagnosis of Waldenstrom's macroglobulinemia
             (WM)/lymphoplasmacytic lymphoma (LPL). Participants must have measurable disease as
             determined by IgM protein quantification. Testing to establish baseline disease status
             must be performed within 28 days prior to registration

          -  Participants must have at least one of the criteria to require therapy for WM
             including anemia, thrombocytopenia, neuropathy related to WM, symptomatic
             hyperviscosity or serum viscosity levels greater than 4.0 centipoises, WM associated
             glomerulonephritis or renal disease, bulky disease, or constitutional symptoms.
             Constitutional symptoms can be described as unintentional weight loss >= 10% within
             the previous 6 months prior to screening; Fevers higher than 100.5 degrees Fahrenheit
             (F) or 38.0 degrees Celsius (C) for 2 or more weeks prior to screening without
             evidence of infection; Night sweats for more than 1 month prior to screening without
             evidence of infection; Clinically relevant fatigue which is not relieved by rest due
             to WM

          -  Participants who require ongoing use or received a moderate or strong CYP3A inducer,
             moderate or strong CYP3A inhibitor, P-gp inihibitor within 7 days prior to the first
             dose of study drug will be excluded from the study. If such participants can be safely
             switched to an alternative agent, then the participants will be eligible to enroll

          -  Participants must be >= 18 years of age

          -  Participants must have history and physical exam within 28 days prior to registration

          -  Participants must have Zubrod performance status =< 2

          -  Participants must have evidence of adequate renal function, as defined by creatinine
             clearance (CrCl) >= 30 mL/min. Values must be obtained within 14 days prior to
             registration

          -  Participants must have no evidence of marked hepatic dysfunction on any recent liver
             function tests within 14 days prior to registration

          -  Platelet count >= 50,000 cells/mm^3 (without transfusion or growth factor support
             within 14 days prior to registration)

          -  Hemoglobin >= 7.0 g/dL (without transfusion or growth factor support within 14 days
             prior to registration)

          -  Absolute neutrophil count (ANC) >= 1,000 cells/mm^3 (without transfusion or growth
             factor support within 14 days prior to registration)

          -  Participants with known human immunodeficiency virus (HIV)-infection are eligible
             providing they are on effective anti-retroviral therapy and have undetectable viral
             load at their most recent viral load test and within 6 months prior to registration

          -  Participants must be able to take and swallow oral medication (capsules) whole.
             Participants may not have any known impairment of gastrointestinal function or
             gastrointestinal disease that may significantly alter the absorption of the study drug
             (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption
             syndrome, or small bowel resection)

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             stage I or II cancer from which the participant is currently in complete remission, or
             any other cancer from which the participant has been disease free for two years or
             watchful waiting is appropriate in the opinion of the treating physician. Also,
             malignancy that in the opinion of the investigator, is considered cured with minimal
             risk of recurrence within 5 years, is permissible consideration of eligibility for
             this trial

          -  Participants must be offered the opportunity to participate in specimen banking

          -  Participants must be informed of the investigational nature of this study and must
             sign and give informed consent in accordance with institutional and federal
             guidelines. For participants with impaired decision-making capabilities, legally
             authorized representatives may sign and give informed consent on behalf of study
             participants in accordance with applicable federal, local, and Central Institutional
             Review Board (CIRB) regulations

          -  As a part of the OPEN registration process the treating institution's identity is
             provided in order to ensure that the current (within 365 days) date of institutional
             review board approval for this study has been entered in the system

          -  CROSSOVER CRITERIA: Participants must have been registered and received treatment in
             the IR arm, and must show progression of disease at any time during cycles 3-24

          -  CROSSOVER CRITERIA: In case of transformation to intermediate or high-grade lymphoma
             or development of Bing-Neel syndrome the participants will not undergo registration
             step 2 crossover and will be taken off the study

          -  CROSSOVER CRITERIA: Participants must have Zubrod performance status =< 2

          -  CROSSOVER CRITERIA: Participants must have evidence of adequate renal function, as
             defined by creatinine clearance (CrCl) >= 30 mL/min. Values must be obtained within 14
             days prior to registration

          -  CROSSOVER CRITERIA: Participants must have no evidence of marked hepatic dysfunction
             on any recent liver function tests within 14 days prior to registration

          -  CROSSOVER CRITERIA: Platelet count >= 50,000 cells/mm^3 (without transfusion or growth
             factor support within 14 days prior to registration)

          -  CROSSOVER CRITERIA: Hemoglobin >= 8.0 g/dL (without transfusion or growth factor
             support within 14 days prior to registration)

          -  CROSSOVER CRITERIA: Absolute neutrophil count (ANC) >= 1,000 cells/mm^3 (without
             transfusion or growth factor support within 14 days prior to registration)

        Exclusion Criteria:

          -  Participants must not have had prior systemic therapy. Prior therapy with rituximab
             will be allowed as long as the last rituximab dose was at least 12 months prior to
             registration

          -  Participants must not be intolerant to rituximab

          -  Participants must not have known active bacterial, viral, fungal, mycobacterial,
             parasitic, or other infection (excluding fungal infections of nail beds) at study
             enrollment, or any major episode of infection requiring treatment with IV antibiotics
             or hospitalization (relating to the completion of the course of antibiotics) 4 weeks
             prior to registration

          -  Participants must not be seropositive for hepatitis C (except in the setting of
             sustained virologic response, defined as undetectable viral load at least 12 weeks
             after completion of antiviral therapy). Hepatitis C virus (HCV) testing is only
             required if clinically indicated or if the participant has a history of HCV

          -  Participants must not consume grapefruit, Seville oranges or starfruit within 3 days
             prior to the first dose of venetoclax

          -  Participants must not be pregnant or nursing because venetoclax has not been studied
             in pregnant or nursing women and the mechanism of action is expected to cause fetal
             harm. A woman is considered to be of "reproductive potential" if she has had menses at
             any time in the preceding 12 consecutive months. In addition to routine contraceptive
             methods, "effective contraception" e.g., implants, injectables, combined oral
             contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized
             partner) and a barrier method (e.g., condom, cervical ring, sponge, etc.). This also
             includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a
             side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy
             or bilateral tubal ligation. However, if at any point a previously celibate
             participant chooses to become heterosexually active during the time period for use of
             contraceptive measures outlined in the protocol, he/she is responsible for beginning
             contraceptive measures throughout the study and for at least 30 days after competition
             of therapy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sikander Ailawadhi, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04840602

Organization ID

NCI-2021-02851

Secondary IDs

NCI-2021-02851

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Sikander Ailawadhi, Principal Investigator, Southwest Oncology Group


Verification Date

July 2021