Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

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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

Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

Official Title

A Phase I Trial of Lenalidomide, Umbralisib and Ublituximab in Patients With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

Brief Summary

      This phase I trial studies the safety and how effective the combination of ublituximab,
      umbralisib, and lenalidomide is in certain types of indolent (slow-growing) non-Hodgkin's
      lymphoma or mantle cell lymphoma. Lenalidomide may stimulate the immune system in different
      ways and stop cancer cells from growing. Lenalidomide may also stop the growth of
      non-Hodgkin's lymphoma by blocking blood flow to the cancer. Umbralisib is designed to block
      a protein called PI3 kinase in order to stop cancer growth and cause changes in the immune
      system that may allow the immune system to better act against cancer cells. Ublituximab is an
      antibody that attaches to the lymphoma cells and triggers immune reactions that may result in
      the death of the targeted lymphoma cells.
    

Detailed Description

      PRIMARY OBJECTIVE:

      I. Determine the recommended phase 2 dose (RP2D) and toxicity of lenalidomide, umbralisib and
      ublituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL) or
      mantle cell lymphoma (MCL).

      SECONDARY OBJECTIVES:

      I. Determine the overall response rate (ORR) for patients with relapsed or refractory
      follicular lymphoma (FL) treated at the RP2D.

      II. Determine duration of response (DOR), progression-free survival (PFS), time to treatment
      failure and overall survival (OS) for patients with relapsed or refractory FL treated at the
      RP2D.

      OUTLINE: This is a dose-escalation study of lenalidomide and umbralisib.

      Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 and umbralisib PO QD
      on days 1-28. Beginning in cycle 2, patients also receive ublituximab intravenously (IV) over
      90 minutes to 4 hours on day 1. Treatment repeats every 28 days for up to 6 cycles in the
      absence of disease progression or unacceptable toxicity. Patients who achieve a partial or
      complete response after cycle 6 continue treatment of lenalidomide PO QD and umbralisib PO QD
      for 12 additional cycles, and ublituximab IV on day 1 of subsequent even cycles (8, 10, 12,
      14, 16, and 18). Patients with stable disease after cycle 6 may continue on treatment for an
      additional 12 cycles at the discretion of the investigator.

      After completion of study treatment, patients are followed up within 8 weeks, and then every
      6 months for 2 years.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Recommended phase 2 dose (RP2D)

Secondary Outcome

 Duration of overall response

Condition

Recurrent B-Cell Non-Hodgkin Lymphoma

Intervention

Lenalidomide

Study Arms / Comparison Groups

 Treatment (lenalidomide, umbralisib, ublituximab)
Description:  Patients receive lenalidomide PO QD on days 1-21 and umbralisib PO QD on days 1-28. Beginning in cycle 2, patients also receive ublituximab IV over 90 minutes to 4 hours on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial or complete response after cycle 6 continue treatment of lenalidomide PO QD and umbralisib PO QD for 12 additional cycles, and ublituximab IV on day 1 of subsequent even cycles (8, 10, 12, 14, 16, and 18). Patients with stable disease after cycle 6 may continue on treatment for an additional 12 cycles at the discretion of the investigator.

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

42

Start Date

June 1, 2021

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Documentation of disease at diagnosis and/or relapse (local pathology review is
             allowed):

               -  Patients in the dose-escalation portion of the study must have histologically
                  confirmed, low-grade B-cell NHL by the World Health Organization (WHO)
                  classification:

                    -  Follicular lymphoma (FL) grade 1, 2, or 3a

                    -  Marginal zone B-cell lymphoma (MZL), including extranodal, nodal and splenic

                    -  Lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia

                    -  Mantle cell lymphoma (MCL)

          -  For the expansion cohort, patients must have histologically confirmed FL grade 1, 2,
             or 3a

          -  Patients with FL or MZL must have had at least one prior systemic therapy. Patients
             with MCL or LPL/Waldenström macroglobulinemia must have had prior treatment with at
             least 2 systemic treatments that included a BTK inhibitor (stopped due to progression
             or intolerance).

          -  Must be in need of treatment for relapsed or refractory disease as assessed by the
             investigator

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

          -  Patients must have radiographically measurable disease

               -  Patients with LPL/Waldenstrom macroglobulinemia or MZL without radiographically
                  measurable disease may be included if they have a measurable serum monoclonal
                  protein (M protein)

          -  Absolute neutrophil count (ANC) > 1,000/mcL

          -  Platelet count > 75,000/mcL

          -  Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) (unless due to
             Gilbert's disease)

          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) <
             2.5 x institutional ULN

          -  Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x
             institutional ULN

          -  Renal function assessed by calculated creatinine clearance as follows (Cockcroft-Gault
             estimation of creatinine clearance [CrCl]):

               -  Patients in the dose-escalation portion of the study must have calculated
                  creatinine clearance >= 60 ml/min by Cockcroft-Gault formula

               -  Patients in the expansion cohort must have calculated creatinine clearance >= 30
                  ml/min by Cockcroft-Gault formula

               -  Patients on dialysis are not eligible

          -  Participants must agree to ongoing anticoagulation as prophylaxis against deep vein
             thrombosis (DVT) using aspirin (81 or 325 mg) daily, warfarin or low molecular weight
             heparin, or a patient already taking another oral anticoagulant (e.g. direct thrombin
             inhibitors for atrial fibrillation) may continue that agent

          -  All study participants must be registered into the mandatory Revlimid REMS program,
             and be willing and able to comply with the requirements of the REMS program

          -  A woman of childbearing potential (WOCBP) is a sexually mature female who: 1) has not
             undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
             postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in
             the preceding 12 consecutive months)

               -  Female patients who are WOCBP must agree to practice:

                    -  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

                    -  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)

                    -  A WOCBP must have a negative serum or urine pregnancy test with a
                       sensitivity of at least 50 mIU/mL within 10-14 days prior to and again
                       within 24 hours of starting therapy with Revlimid. Females of reproductive
                       potential must adhere to the scheduled pregnancy testing as required in the
                       Revlimid REMS program

          -  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)

                    -  Subjects must have the ability to understand and the willingness to sign a
                       written informed consent document and Health Insurance Portability and
                       Accountability Act (HIPAA) consent document. 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

        Exclusion Criteria:

          -  Known or suspected active diffuse large B-cell lymphoma (DLBCL). Patients with prior
             history of DLBCL may be enrolled if their DLBCL has been previously treated and - in
             the opinion of the investigator - is not active

          -  Patients who have not recovered (i.e., >= grade 2 toxicity) from adverse events due to
             agents administered more than 4 weeks earlier, and patients who have any grade
             pulmonary or related infections thought to be associated with pneumonitis, or any
             grade colitis

          -  Major surgery within 14 days before day 1, cycle 1 of treatment

          -  Radiotherapy within 14 days before day 1, cycle 1 of treatment

          -  Patients with prior systemic therapy must have had a minimum of 14 days from prior
             treatment with a BTK inhibitor, or 21 days from prior treatment with chemotherapy or
             any other therapy and day 1, cycle 1 of treatment. Concurrent glucocorticoid therapy
             as long as started for at least 7 days prior to study entry (=< 20 mg per day of
             prednisone or equivalent) is allowed as clinically warranted

          -  Known central nervous system involvement. Subjects with symptoms of central nervous
             system (CNS) disease must have a negative computed tomography (CT) scan and negative
             diagnostic lumbar puncture

          -  Any prior use of lenalidomide

          -  Any prior use of idelalisib (CAL-101), duvelisib (IPI-145), copanlisib or any other
             drug that specifically inhibits phosphoinositide-3-kinase (PI3K)

          -  Prior allogeneic stem cell transplantation. Prior autologous stem cell transplant is
             allowed, if it was 6 months or longer ago

          -  Active systemic bacterial, fungal or viral infection except localized fungal
             infections of skin or nails. Patients with resolving infections such as urinary tract,
             respiratory, other than a respiratory infection thought to be associated with
             pneumonitis, or skin infections may be enrolled if clinically improving. NOTE:
             Subjects may be receiving prophylactic antiviral or antibacterial therapies at
             investigator discretion. Use of anti-pneumocystis and antiviral prophylaxis is
             required for subjects receiving umbralisib

          -  Patients with a history of deep vein thrombosis (DVT) or pulmonary embolus (PE) within
             3 months before study entry are not eligible. Patients with history of DVT/PE greater
             than 3 months are eligible but recommended to receive aspirin, molecular weight
             heparin or direct thrombin inhibitor unless contraindicated

          -  Evidence of current uncontrolled or symptomatic cardiovascular conditions, including,
             uncontrolled cardiac arrhythmias, history of or symptomatic congestive heart failure
             (NYHA class II or greater), unstable angina, or myocardial infarction within the past
             6 months. Poorly controlled or clinically significant atherosclerotic vascular disease
             including cerebrovascular accident (CVA), transient ischemic attack (TIA),
             angioplasty, cardiac or vascular stenting within 6 months of enrollment. Concomitant
             use of medication known to cause QT prolongation or torsade de pointes should be used
             with caution and at investigator discretion

          -  .Patients with history of autoimmune hepatitis, autoimmune or drug-induced colitis
             including inflammatory bowel disease (ulcerative colitis or Crohn's disease), and/or
             autoimmune or drug-induced pneumonitis

          -  Known history of drug-induced liver injury, alcoholic liver disease, non-alcoholic
             steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by
             stones, or cirrhosis of the liver

          -  Known gastrointestinal (GI) disease or gastrointestinal procedure that will
             significantly interfere with the oral absorption or tolerance of umbralisib or
             lenalidomide including inability to swallow pills/capsules

          -  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 any of the study medications, their analogues, or excipients in the
             various formulations of any agent. Specifically, prior desquamating rash, erythema
             nodosum, toxic epidermal necrolysis, or Stevens-Johnson syndrome during prior
             thalidomide or other similar agents

          -  No evidence of prior malignancy except: DLBCL, adequately treated non-melanoma skin
             cancer, adequately treated in situ carcinoma, low grade prostate carcinoma (Gleason
             grade =< 6) managed with observation that has been stable for at least 6 months, or
             any malignancy treated with curative intent and continuously disease free for at least
             3 years

          -  Ongoing immunosuppressive therapy (such as tacrolimus, cyclosporine, mycophenolate,
             methotrexate, tumor necrosis factor [TNF] inhibitors, alemtuzumab). Systemic
             corticosteroids (prednisone or equivalent =< 20 mg daily) are allowed as clinically
             warranted. Patients are allowed to use topical or inhaled corticosteroids

          -  Participation in other interventional clinical trials, including those with other
             investigational agents not included in this trial, within 21 days of day 1, cycle 1 of
             this trial. Also excluded are patients who are receiving any other investigational
             agents outside of a clinical trial

          -  Evidence of chronic active hepatitis B (hepatitis B virus [HBV], not including
             patients with prior hepatitis B vaccination; or positive serum hepatitis B antibody)
             or chronic active hepatitis C infection (HCV), active cytomegalovirus (CMV), or known
             history of human immunodeficiency syndrome (HIV). If hepatitis B core (HBc) antibody
             is positive, the subject must be evaluated for the presence of HBV deoxyribonucleic
             acid (DNA) by polymerase chain reaction (PCR). If HCV antibody is positive, the
             subject must be evaluated for the presence of HCV ribonucleic acid (RNA) by PCR. If
             the subject is CMV immunoglobulin G (IgG) or CMV IgM positive, the subject must be
             evaluated for the presence of CMV DNA by PCR. Subjects with positive HBc antibody and
             negative HBV DNA by PCR are eligible. Subjects with positive HCV antibody and negative
             HCV RNA by PCR are eligible. Subjects who are CMV IgG or CMV IgM positive but who are
             CMV DNA negative by PCR are eligible

          -  Pregnant or breastfeeding women are excluded from this study because lenalidomide has
             known teratogenic effects. Because there is an unknown, but potential risk for adverse
             events in nursing infants secondary to treatment of the mother with lenalidomide,
             breastfeeding should be discontinued if the mother is treated with lenalidomide. These
             potential risks may also apply to other agents used in this study

          -  History of anaphylaxis (excluding infusion related reactions) in association with
             previous anti-CD20 administration

          -  Live virus vaccines within 4 weeks prior to ublituximab therapy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Yazeed Sawalha, MD, 800-293-5066, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04635683

Organization ID

OSU-19317

Secondary IDs

NCI-2020-08369

Responsible Party

Sponsor-Investigator

Study Sponsor

Yazeed Sawalha


Study Sponsor

Yazeed Sawalha, MD, Principal Investigator, Ohio State University Comprehensive Cancer Center


Verification Date

May 2021