Efficacy of Venetoclax in Combination With Rituximab in Waldenström’s Macroglobulinemia

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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

Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia

Official Title

Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia

Brief Summary

      In Waldenström's macroglobulinemia (WM) chemotherapy induces only low CR/VGPR rates and
      response duration is limited. In addition, WM patients are often elderly, partly not
      tolerating chemotherapy related toxicities. Thus, innovative approaches are needed which
      combine excellent activity and tolerability in WM. Chemotherapy-free approaches are highly
      attractive for this patient group. Based on its high activity and favorable toxicity profile
      in indolent B-NHL such as CLL, Venetoclax was approved for the treatment of this diseases by
      the FDA and the European Medicines Agency (EMA). First data in relapsed/refractory WM have
      documented high activity and low toxicity of Venetoclax also in WM, including patients with
      prior Ibrutinib treatment or patients carrying CXCR4 mutations. Ibrutinib itself has high
      activity and a relatively low toxicity profile in WM, but has also major disadvantages: the
      main disadvantage is the need to apply this drug continuously. Furthermore, Ibrutinib
      efficacy depends largely on the genotype with a substantial drop in major responses and PFS
      in the presence of CXCR4 mutations and non-mutated MYD88. In particular the need of
      continuous treatment for Ibrutinib has prevented that Ibrutinib has become the standard of
      care outcompeting conventional Rituximab/chemotherapy. This is reflected in current
      guidelines such as the NCCN and the ESMO guidelines, which still see immunochemotherapy as a
      backbone of treatment, largely because of the advantage of a timely fixed application. Data
      in CLL in the relapsed as well as in the first line setting have convincingly shown that in
      contrast to Ibrutinib Venetoclax is highly efficient also when used in a timely defined
      application scheme over 12 months in combination with the anti-CD20 antibody Rituximab. Data
      documented deep responses including molecular responses and a highly significant advantage
      over immunochemotherapy in large international Phase III trials, changing the standard of
      care in this disease.

      Based on this the hypothesis is that timely fixed application of the combination of
      Venetoclax and Rituximab induces significantly superior treatment outcomes compared to
      chemotherapy and Rituximab (DRC) in patients with treatment naïve WM, regardless of the
      genotype. A confirmation of this assumption in the proposed trial will change the standard of
      care in WM.
    

Detailed Description

      In Waldenström's macroglobulinemia (WM) chemotherapy induces only low CR/VGPR rates and
      response duration is limited. In addition, WM patients are often elderly, partly not
      tolerating chemotherapy related toxicities. Thus, innovative approaches are needed which
      combine excellent activity and tolerability in WM. Chemotherapy-free approaches are highly
      attractive for this patient group. Based on its high activity and favorable toxicity profile
      in indolent B-NHL such as CLL, Venetoclax was approved for the treatment of this diseases by
      the FDA and the European Medicines Agency (EMA). First data in relapsed/refractory WM have
      documented high activity and low toxicity of Venetoclax also in WM, including patients with
      prior Ibrutinib treatment or patients carrying CXCR4 mutations. Ibrutinib itself has high
      activity and a relatively low toxicity profile in WM, but has also major disadvantages: the
      main disadvantage is the need to apply this drug continuously. Furthermore, Ibrutinib
      efficacy depends largely on the genotype with a substantial drop in major responses and PFS
      in the presence of CXCR4 mutations and non-mutated MYD88. In particular the need of
      continuous treatment for Ibrutinib has prevented that Ibrutinib has become the standard of
      care outcompeting conventional Rituximab/chemotherapy. This is reflected in current
      guidelines such as the NCCN and the ESMO guidelines, which still see immunochemotherapy as a
      backbone of treatment, largely because of the advantage of a timely fixed application. Data
      in CLL in the relapsed as well as in the first line setting have convincingly shown that in
      contrast to Ibrutinib Venetoclax is highly efficient also when used in a timely defined
      application scheme over 12 months in combination with the anti-CD20 antibody Rituximab. Data
      documented deep responses including molecular responses and a highly significant advantage
      over immunochemotherapy in large international Phase III trials, changing the standard of
      care in this disease.

      Based on this the hypothesis is that timely fixed application of the combination of
      Venetoclax and Rituximab induces significantly superior treatment outcomes compared to
      chemotherapy and Rituximab (DRC) in patients with treatment naïve WM, regardless of the
      genotype. A confirmation of this assumption in the proposed trial will change the standard of
      care in WM.

      This study is an International phase II explorative, multicenter, open label, and randomized
      trial.

      The study will consist of an open labeled, stratified 1:1 randomization between Arm A and Arm
      B for de novo WM patients in need of treatment (phase II). Stratification factors are MYD88
      and CXCR4 status (positive vs. negative). A stratified central block randomization will be
      used. The central randomization service will be used to avoid predictability of the treatment
      arm.

      The primary goal of this study is to explore the efficacy of Venetoclax plus Rituximab versus
      Dexamethasone/Cyclophosphamide/Rituximab in the treatment of de novo WM patients (Arm A vs.
      Arm B).

      80 patients are planned to be recruited for this study at 30 sites in Germany and France.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rate of CR / VGPR

Secondary Outcome

 Response rate

Condition

Waldenstrom Macroglobulinemia

Intervention

Venetoclax; Rituximab

Study Arms / Comparison Groups

 Venetoclax / Rituximab
Description:  Cycle 1 (28-days cycle) Stepwise dose escalation of Venetoclax in all patients with a target dose of 800 mg/d QD PO.
Day 1-7: Venetoclax 200 mg/d QD PO Day 8-14: Venetoclax 400 mg/d QD PO Day 15-28: Venetoclax 800 mg/d QD PO
Cycle 2-12:
Day 1: Rituximab 375 mg/m2 IV Day 1-28: Venetoclax 800 mg/d QD PO

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

80

Start Date

September 2022

Completion Date

December 2029

Primary Completion Date

December 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Proven clinicopathological diagnosis of WM as defined by consensus panel one of the
             Second International Workshop on WM (IWWM). Histopathology has to be perfomed before
             randomization within the last 4 months. In addition, pathological specimens have to be
             sent to the national pathological reference center prior to randomization for the
             determination of the mutational status of MYD88 and CXCR4 if the mutational status
             hasn't been determined before. Immunophenotyping will be performed in each center and
             archived locally. Flow cytometry of bone marrow and blood cells will include at least
             one double staining and assess the expression of the following antigens: surface
             immunoglobulin, CD19, CD20, CD5, CD10, CD38 and CD23. Patients are eligible if tumor
             cells express the following antigens: CD19, CD20, CD38 and if they are negative for
             CD5, CD10 and CD23 expression. Patients with tumor cells positive for CD5 and/or CD23
             and morphologically similar to WM cells may be included after ruling out other
             low-grade B-cell malignancies.

          -  De novo WM independent of the genotype.

          -  Patients must have at least one of the following criteria to start study treatment as
             partly defined by consensus panel criteria from the Seventh IWWM:

               -  Recurrent fever, night sweats, weight loss, fatigue (at least one of them).

               -  Hyperviscosity.

               -  Lymphadenopathy which is either symptomatic or bulky (≥ 5 cm in maximum
                  diameter).

               -  Symptomatic hepatomegaly and / or splenomegaly.

               -  Symptomatic organomegaly and / or organ or tissue infiltration.

               -  Peripheral neuropathy due to WM.

               -  Symptomatic cryoglobulinemia.

               -  Cold agglutinin anemia.

               -  IgM related immune hemolytic anemia and/or thrombocytopenia.

               -  Nephropathy related to WM.

               -  Amyloidosis related to WM.

               -  Hemoglobin ≤ 10 g/dL (patients should not have received red blood cells
                  transfusions for at least 7 days prior to obtaining the screening hemoglobin).

               -  Platelet count < 100 x 109/L (caused by bone marrow [BM] infiltration of the
                  lymphoma).

               -  Serum monoclonal protein > 5 g/dL, even with no overt clinical symptoms.

               -  IgM serum concentration ≥ 5 g/dL.

               -  and other WM associated relevant symptoms

          -  Subject must be ≥ 18 years of age.

          -  Life expectancy > 3 months.

          -  World Health Organization (WHO) / ECOG performance status ≤ 2.

          -  Left ventricular ejection fraction ≥ 40% as assessed by transthoracic echocardiogram
             (TTE).

          -  Baseline platelet count ≥ 50x109/L, absolute neutrophil count ≥ 0.75x109/L (if not due
             to BM infiltration by the lymphoma).

             . Adequate hepatic function per local laboratory reference range as follows:

               -  Aspartate transaminase (AST) and alanine transaminase (ALT) < 3.0 x ULN.

               -  Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of
                  non-hepatic origin).

          -  Subject must have adequate renal function as demonstrated by a creatinine clearance ≥
             30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine
             collection.

          -  Females of childbearing potential (FCBP), i.e. fertile, following menarche and until
             becoming postmenopausal must have negative results for pregnancy test and must agree
             to use a highly effective method of birth control for the duration of the therapy up
             to 12 months after end of therapy

          -  Men must agree not to father a child for the duration of therapy and 12 months after
             and must agree to advice their female partner to use a highly effective method of
             birth control. Males must refrain from sperm donation for the duration of treatment
             and at least 12 months after the last dose of study medication.

          -  Each patient must voluntarily date and sign an informed consent form in the native
             language of the patient indicating that he or she understands the purpose of and
             procedures required for the study and are willing to participate in the study.
             Patients must be willing and able to adhere to the prohibitions and restrictions
             specified in this protocol.

          -  Affiliation to a social security scheme (relevant for France only).

        Exclusion Criteria:

          -  Serious medical or psychiatric illness (especially undergoing treatment) likely to
             interfere with participation in this clinical study.

          -  Subject is known to be positive for HIV.

          -  Active severe infection

          -  Congenital or acquired severe immunodeficiency not attributed to lymphoma (clinical
             appearance: recurrent infections, necessity of immunoglobulin substitution therapy,
             patients after transplantation)

          -  Evidence of other clinically significant uncontrolled condition(s) including, but not
             limited to:

               -  Uncontrolled systemic infection (viral, bacterial or fungal).

               -  Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring
                  treatment. Note: subjects with serologic evidence of prior vaccination to HBV
                  (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and
                  anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from
                  intravenous immunoglobulins (IVIG) may participate

          -  adequate pulmonary function as demonstrated by DLCO ≤ 65% or FEV1 ≤ 65%.

          -  Creatinine clearance ≥ 30 mL/min to < 45 ml/min

          -  Uncontrolled diabetes mellitus (as indicated by metabolic derangements and / or severe
             diabetes mellitus related uncontrolled organ complications).

          -  Uncontrolled hypertension.

          -  Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 50% or chronic
             stable angina.

          -  Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6
             months prior to start therapy.

          -  Clinically significant cardiac arrhythmia that is symptomatic or requires treatment,
             or asymptomatic sustained ventricular tachycardia.

          -  Subject has a cardiovascular disability status of New York Heart Association Class >
             2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but
             ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.

          -  History of stroke or intracranial haemorrhage within 6 months prior start of treatment

          -  Known pericardial disease.

          -  Known interstitial lung disease.

          -  Infiltrative pulmonary disease, known pulmonary hypertension.

          -  Prior history of malignancies unless the subject has been free of the disease for ≥ 3
             years. Exceptions include the following:

               -  Basal cell carcinoma of the skin,

               -  Squamous cell carcinoma of the skin,

               -  Carcinoma in situ of the cervix,

               -  Carcinoma in situ of the breast,

               -  Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b).

          -  Primary amyloidosis.

          -  Known cirrhosis (meeting child-pugh stage C).

          -  Chemotherapy with approved or investigational anticancer therapeutic within 21 days
             prior to start of therapy

          -  Glucocorticoid therapy within 14 days prior to therapy that exceeds a cumulative dose
             of 160 mg of dexamethasone or equivalent dose of other corticosteroids given for
             anti-neoplastic intent.

          -  Treatment with any of the following within 7 days prior to the first dose of study
             drug:

               -  moderate or strong cytochrome P450 3A (CYP3A) inhibitors (such as fluconazole,
                  ketoconazole, and clarithromycin).

               -  moderate or strong CYP3A inducers (such as rifampin, carbamazepine, phenytoin,
                  St. John's wort).

          -  Contraindication to any of the required concomitant drugs or supportive treatments,
             including hypersensitivity to antiviral drugs.

          -  Autologous stem cell transplant less than 90 days prior to randomization.

          -  Allogeneic stem cell transplant less than 100 days prior to randomization.

          -  Vaccination with live attenuated vaccines within 4 weeks prior to start of therapy.

          -  History or evidence of any other clinically significant disorder, condition or disease
             (with the exception of those outlined above) that, in the opinion of the investigator
             or sponsor, if consulted, would pose a risk to subject safely or interfere with the
             study evaluation, procedures or completion.

          -  Women who are pregnant as well as women who are breast-feeding and do not consent to
             discontinue breast-feeding.

          -  Participation in another clinical trial within four weeks before start of therapy in
             this study.

          -  No consent for registration, storage and processing of the individual
             disease-characteristics.

          -  Administration or consumption of any of the following within 3 days prior to the first
             dose of study drug:

               -  grapefruit or grapefruit products.

               -  Seville oranges (including marmalade containing Seville oranges).

               -  star fruit.

          -  Person of legal age who is incapable of comprehending the nature, significance and
             implications of the clinical trial and of determining his/her will in the light of
             these facts
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christian Buske, Prof. Dr., +49500, [email protected]



Administrative Informations


NCT ID

NCT05099471

Organization ID

VIWA-1


Responsible Party

Principal Investigator

Study Sponsor

University of Ulm

Collaborators

 Institute for Medical Informatics, Biometry and Epidemiology, University of Munich

Study Sponsor

Christian Buske, Prof. Dr., Principal Investigator, University Hospital Ulm Department of Internal Medicine III


Verification Date

July 2022