Clinical Trials /

A Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL

NCT04594798

Description:

The purpose of this study is to test the effectiveness and safety of polatuzumab vedotin in combination with R-miniCHP in patients 75 years and older with DLBCL.

Related Conditions:
  • Composite Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Grade 3b Follicular Lymphoma
  • High Grade B-Cell Lymphoma with MYC and BCL2 and/or BCL6 Rearrangements
  • High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Transformed Non-Hodgkin Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL
  • Official Title: Phase 2 Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL

Clinical Trial IDs

  • ORG STUDY ID: ULYM20030
  • NCT ID: NCT04594798

Conditions

  • DLBCL
  • Lymphoma, B-Cell

Interventions

DrugSynonymsArms
Polatuzumab vedotinExperimental: Polatuzumab Vedotin and R-CHOP
RituximabExperimental: Polatuzumab Vedotin and R-CHOP
CyclophosphamideExperimental: Polatuzumab Vedotin and R-CHOP
DoxorubicinExperimental: Polatuzumab Vedotin and R-CHOP
PrednisoneExperimental: Polatuzumab Vedotin and R-CHOP

Purpose

The purpose of this study is to test the effectiveness and safety of polatuzumab vedotin in combination with R-miniCHP in patients 75 years and older with DLBCL.

Detailed Description

      In this study, the investigator would like to better understand the efficacy and safety of
      the addition of polatuzumab vedotin to therapy with rituximab, cyclophosphamide, doxorubicin,
      vincristine and prednisone (R-CHOP) and dose attenuated R-CHOP in patients who are aged 75
      years and older.
    

Trial Arms

NameTypeDescriptionInterventions
Experimental: Polatuzumab Vedotin and R-CHOPExperimentalThe dose of polatuzumab vedotin for each patient will be 1.8 mg/kg (IV for 21 days)
  • Polatuzumab vedotin
  • Rituximab
  • Cyclophosphamide
  • Doxorubicin
  • Prednisone

Eligibility Criteria

        Inclusion Criteria:

          -  Voluntary written informed consent before performance of any study-specific procedure
             not part of routine medical care, with the understanding that consent may be withdrawn
             by the subject at any time without prejudice to future medical care. Subjects must be
             able to understand and be willing to sign the written informed consent form.

          -  Men and women aged greater than or equal to 75 years of age

          -  ECOG performance status of 0-3

          -  Histologically-confirmed DLBCL, NOS, NOS, high grade B-cell lymphoma with MYC, BCL2
             and/or BCL6 rearrangements, high grade B-cell lymphoma, NOS, and grade 3b follicular
             lymphoma by 2016 WHO classification by site hematopathologist

               -  Histologic transformation (HT) will be included on the study. This must be
                  confirmed with a biopsy. Patients with HT may have received prior treatment for
                  indolent lymphoma including chemoimmunotherapy, but must not have received an
                  anthracycline-containing regimen in the past. Patients with Richter's
                  transformation will be eligible.

               -  Composite and discordant lymphomas containing both indolent and large cell
                  features will be included

          -  Has received no prior therapy for aggressive B-cell lymphoma or HT with the following
             exceptions:

               -  A course of corticosteroids given for lymphoma related symptoms.

               -  A course of cyclophosphamide or vincristine with or without steroids given for
                  lymphoma related symptoms.

               -  One cycle of anthracycline containing chemotherapy such as R-CHOP or R-miniCHOP
                  given urgently for aggressive disease.

        Patient is not felt to be a candidate for standard dose R-CHOP due to age or comorbidities,
        per the site investigator.

          -  Ejection fraction of ≥ 45% on echocardiogram or MUGA

          -  Patient has a platelet count of ≥75,000/μL within 14 days before enrollment unless
             inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma

          -  Patient has an absolute neutrophil count of ≥1,500/ μL within 14 days before
             enrollment unless inadequate function is due to bone marrow infiltration with
             aggressive B-cell lymphoma

          -  Patient has a calculated or measured creatinine clearance of >30 mL/minute within 14
             days before enrollment.

          -  Total bilirubin must be less than 1.5 times the upper limit of normal (ULN) unless the
             elevation is known to be due to Gilbert syndrome or hepatic involvement with
             aggressive B-cell lymphoma in which case it can be ≤ 3.0 times the ULN.

          -  ALT or AST must be ≤ 2.5 times the ULN.

          -  For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
             a condom, and agreement to refrain from donating sperm, as defined below:

               -  With female partners of childbearing potential or pregnant female partners, men
                  must remain abstinent or use a condom during the treatment period and for at
                  least 5 months after the last dose of polatuzumab vedotin to avoid exposing the
                  embryo or fetus for the duration of the pregnancy. Men must refrain from donating
                  sperm during this same period.

               -  The reliability of sexual abstinence should be evaluated in relation to the
                  duration of the clinical trial and the preferred and usual lifestyle of the
                  patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or
                  postovulation methods) and withdrawal are not acceptable methods of preventing
                  drug exposure. Male patients considering preservation of fertility should bank
                  sperm before study treatment.

        Exclusion Criteria:

          -  History of, or clinically apparent central nervous system (CNS) lymphoma

          -  Primary mediastinal B-cell lymphoma or EBV positive DLBCL

          -  Patient is receiving peritoneal dialysis or hemodialysis

          -  Patient has > Grade 1 peripheral neuropathy.

          -  New York Heart Association class III heart failure or EF <45%

          -  Patient has received other investigational drugs with 14 days before enrollment

          -  Prior exposure to anthracycline except for one cycle of therapy given urgently for
             lymphoma.

          -  Patient has concomitant active malignancy that the treating physician or PI feels may
             interfere with the ability to measure the primary or secondary outcomes

               -  Patients with stage 1 cancers are eligible after definitive treatment.

               -  Patients with low grade prostate cancer who are managed with observation are
                  eligible.

               -  Patients with other malignancies that have been treated with curative intent will
                  be included if they are in documented remission without treatment for ≥ 3 years
                  prior to enrollment.

          -  Patient is known to be HIV positive (test result not required for enrollment).

          -  Patient has active hepatitis B with a positive surface antigen or viral load. Carriers
             of hepatitis B virus should be closely monitored for clinical and laboratory signs of
             active HBV infection and for signs of hepatitis throughout study participation
             according to national and local guidelines. Those at high risk of reactivation should
             be placed on appropriate antiviral therapy as per national guidelines.

          -  History of solid organ transplantation, or post-transplant lymphoproliferative
             disorder

          -  Patient has history of allogeneic stem cell transplantation.

          -  Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study.

          -  Any clinically significant abnormality in screening blood chemistry, hematology, or
             urinalysis results that, in the judgment of the investigator, would impede adequate
             evaluation of adverse
      
Maximum Eligible Age:N/A
Minimum Eligible Age:75 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival
Time Frame:From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Safety Issue:
Description:Measure of time from study enrollment until progression.

Secondary Outcome Measures

Measure:Overall Survival
Time Frame:From date of enrollment until date of death from any cause up to 24 months
Safety Issue:
Description:Measure of time from study enrollment until death from any cause.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Rochester

Trial Keywords

  • polatuzumab vedotin
  • rituximab
  • cyclophosphamide
  • doxorubicin
  • prednisone
  • R-miniCHP
  • DLBCL
  • Lymphoma, B-Cell

Last Updated

October 13, 2020