Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm’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

Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia

Official Title

A Phase II Study of Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia

Brief Summary

      This study evaluates the safety and efficacy of daratumumab in combination with ibrutinib in
      patients with Waldenstrӧm's macroglobulinemia (WM). The study will evaluate this combination
      in two cohorts. Cohort A will comprise of ibrutinib naïve WM patients. Patients in this
      cohort may be treatment naïve or relapsed but who remain ibrutinib naïve. Cohort B will
      comprise of patients who are currently receiving ibrutinib but whose response to treatment
      has plateaued. In this cohort, daratumumab will be added on to ibrutinib in an attempt to
      deepen response.
    

Detailed Description

      This is a multi-center, two cohort Phase 2 clinical trial investigating the effectiveness of
      adding daratumumab to ibrutinib in WM patients. Cohort A will consist of patients who are
      ibrutinib naïve and appropriate for ibrutinib based treatment. Cohort B will consist of
      patients who have achieved a response plateau less than a complete remission (CR) on single
      agent ibrutinib. Subjects in Cohort A will be identified by their treating physician and
      eligible for enrollment if they are treatment naïve or relapsed after 1 prior therapy for WM
      and eligible for ibrutinib based treatment.

      Subjects in Cohort B will be identified by their treating physician and eligible for
      enrollment if they have had at least 6 months of exposure to single agent ibrutinib and
      demonstrate an IgM response plateau defined by two IgM measurements, at least 8 weeks apart
      that have changed <15% from the previous mark. In Cohort B response assessment will be
      measured from initial IgM level prior to ibrutinib initiation.

      Enrolled subjects will be prescribed commercial ibrutinib, 420mg PO daily. The
      investigational agent, daratumumab will be administered based on FDA approved dosing in
      multiple myeloma (16mg/kg) with 8 weekly induction treatments during Cycles 1 and 2, followed
      by every other week dosing for Cycles 3-6, then monthly dosing from Cycle 7 until Cycle 25 at
      which point subjects will continue with ibrutinib as monotherapy until Cycle 52 (4 years
      total) which is the predefined study completion for enrolled subjects at which point they
      will complete follow-up. Study visits and response assessments with IgM measurements will
      occur with each cycle for the first year then every three cycles after cycle 13. Subjects
      with measureable extramedullary disease will have CT scans every 6 cycles until radiographic
      CR. Patients will be considered evaluable for response if they completed the initial 8 weeks
      of daratumumab induction therapy and evaluable for toxicity if receiving one dose of
      daratumumab. Patients will continue on combination therapy for 2 years or until disease
      progression or unacceptable toxicities at which point subjects will come off trial. Patients
      achieving a CR after two years of combination therapy will be given an option to continue
      with single agent commercial ibrutinib.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Safety of combination treatment with ibrutinib and daratumumab as measured by the number of patients that experience 1 or more adverse event

Secondary Outcome

 Major response rate in Cohort A

Condition

Waldenstrom Macroglobulinemia

Intervention

Ibrutinib

Study Arms / Comparison Groups

 Cohort A - Ibrutinib naive
Description:  Cohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab

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

24

Start Date

July 30, 2020

Completion Date

October 2024

Primary Completion Date

October 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects must have a diagnosis of WM and meet the requirements for active therapy as
             defined by the 2nd International Workshop on Waldenstrom's Macroglobulinemia

          -  Age ≥18 years of age

          -  Ibrutinib naïve or previously treated patients currently on ibrutinib with a plateau
             in disease response are eligible to participate.

               1. Ibrutinib naïve subjects may be either treatment naïve or previously treated but
                  ibrutinib naïve to enter cohort A.

               2. Subjects entering cohort B must have a plateau response on ibrutinib defined as ≥
                  6 months of ibrutinib treatment with 2 IgM measurements at least 2 months apart
                  with ≤ 15% change from the previous measurement. Subjects with IgM level < 0.7
                  g/dL will be eligible if their IgM level increases < 0.15 g/dL over two
                  subsequent IgM measurements as defined above.

          -  Subjects must have measurable disease defined by a serum IgM level ≥0.5g/dL

          -  Eastern Cooperative Oncology Group performance status of 0-2

          -  Hematology values must be within the following limits:

               1. Absolute neutrophil count (ANC) ≥ 1000/mm3 independent of growth factor support
                  for 7 days of study entry if cytopenias are due to marrow involvement.

               2. Platelets ≥ 50,000/mm3 independent of transfusion support within 7 days of study
                  entry. TPO mimetics are not allowed to meet eligibility criteria.

               3. Hemoglobin ≥ 8g/dL, independent of transfusion support within 7 days of study
                  entry

          -  Biochemical values within the following limits:

             d. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper
             limit of normal (ULN)

             e. Total bilirubin ≤ 2 x ULN unless bilirubin rise is due to Gilbert's syndrome or of
             non-hepatic origin

             f. Creatinine clearance (CLcr) > 25 ml/min

          -  Women of childbearing potential and men who are sexually active must be practicing a
             highly effective method of birth control during and after the study consistent with
             local regulations regarding the use of birth control methods for subjects
             participating in clinical trials. Men must agree to not donate sperm during and after
             the study. For females, these restrictions apply for 1 month after the last dose of
             study drug. For males, these restrictions apply for 3 months after the last dose of
             study drug.

          -  Women of childbearing potential must have a negative serum (beta-human chorionic
             gonadotropin (beta-hCG) or urine beta hCG pregnancy test at Screening. Women who are
             pregnant or breastfeeding are ineligible for this study.

          -  Subjects must be able to sign (or their legally-acceptable representatives must sign)
             an informed consent indicating that they understand the rational of the study and can
             participate in all study procedures.

        Exclusion Criteria:

          -  Subject does not have a recorded IgM level recorded within 3 months prior to ibrutinib
             initiation.

          -  Subject meeting definition of disease progression while on ibrutinib. Subjects with
             IgM levels < 0.7gdL are given special consideration. Please see inclusion criteria for
             2b.

          -  Subjects in cohort B experiencing ongoing non hematologic toxicities attributable to
             ibrutinib > Grade 1 will be excluded from study entry.

          -  Major surgery or a wound that has not fully healed within 4 weeks of enrollment.

          -  Evidence of disease transformation at time of enrollment.

          -  Waldenstrom's complicated by amyloidosis

          -  Known central nervous system lymphoma.

          -  History of stroke or intracranial hemorrhage within 6 months prior to randomization.

          -  Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg,
             phenprocoumon).

          -  Requires chronic treatment with strong CYP3A inhibitors. Subjects that required strong
             CYP3A inhibitors but completed a course of treatment can be considered for enrollment
             after a washout period of 14 days prior to study drug administration.

          -  Requires strong CYP3A inducers. Subjects that required strong CYP3A inducers but
             completed a course of treatment can be considered for enrollment after a washout
             period of 14 days prior to study drug administration.

          -  Patients with history of Chronic Obstructive Pulmonary Disease or Reactive Airway
             disease must have PFTs with FEV1 calculated. Patients with a FEV1 ≤ 50% of predicted
             normal will be excluded.

          -  Clinically significant cardiovascular disease such as uncontrolled or symptomatic
             arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
             Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by
             the New York Heart Association Functional Classification.

          -  Vaccinated with live, attenuated vaccines within 4 weeks of randomization.

          -  Seropositive for human immunodeficiency virus (HIV).

          -  Seropositive for hepatitis B (defined by a positive test for hepatitis B surface
             antigen [HBsAg]). Subjects with resolved infection (i.e., subjects who are HBsAg
             negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or
             antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time
             polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels.
             Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic
             findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic
             marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV
             DNA by PCR.

          -  Seropositive for hepatitis C (except in the setting of a sustained virologic response
             [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).

          -  Any life-threatening illness, medical condition, or organ system dysfunction which, in
             the investigator's opinion, could compromise the subject's safety, interfere with the
             absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue
             risk.

          -  Active malignancy not treated with curative intent within 2 years of study entry.
             Nonmelanotic skin cancers and cervical carcinoma in situ are excluded from this
             criteria.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

John N. Allan, M.D., 212-746-1362, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03679624

Organization ID

1708018494


Responsible Party

Sponsor

Study Sponsor

Weill Medical College of Cornell University

Collaborators

 Janssen Scientific Affairs, LLC

Study Sponsor

John N. Allan, M.D., Principal Investigator, Weill Medical College of Cornell University


Verification Date

December 2020