Clinical Trials /

A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma

NCT02811679

Description:

This research study is studying Blinatumomab as a possible treatment for Indolent Non-Hodgkin Lymphoma (NHL).

Related Conditions:
  • Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Follicular Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Splenic Marginal Zone Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma
  • Official Title: A Phase II Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: 16-118
  • NCT ID: NCT02811679

Conditions

  • Non-Hodgkin Lymphoma

Interventions

DrugSynonymsArms
BlinatumomabBlincytoBlinatumomab

Purpose

This research study is studying Blinatumomab as a possible treatment for Indolent Non-Hodgkin Lymphoma (NHL).

Detailed Description

      This research study is a Phase II clinical trial. The overall purpose of this study is to
      determine if blinatumomab is safe and effective for treating adult subjects with relapsed or
      refractory indolent B cell NHL.

      Blinatumomab will be infused causing T cells to recognize the Cancer and work against them.
      This approach has been FDA approved for acute lymphocytic leukemia but has not yet been
      approved for lymphoma.
    

Trial Arms

NameTypeDescriptionInterventions
BlinatumomabExperimentalBlinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
  • Blinatumomab

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects must have histologically determined B cell NHL that is relapsed or primary
             refractory after initial therapy.

               -  Follicular Lymphoma of any grade

               -  Marginal zone lymphoma (extranodal, nodal, or splenic). Patients with gastric
                  MALT must have progressed after H. Pylori therapy and radiation. Patients with
                  splenic MZL must have prior splenectomy.

          -  At least 1 prior line of chemoimmunotherapy if primary refractory or relapsed with in
             one year. Subjects who respond to initial therapy for greater than one year must have
             had at least 2 prior lines of therapy including one line with chemoimmunotherapy
             including an anti-CD20 monoclonal antibody

          -  Measurable disease that has not been previously irradiated on PET-CT of at least
             1.5cm,

          -  Age ≥18 years.

          -  ECOG performance status ≤2 ( see Appendix A)

          -  Participants must have adequate organ and marrow function as defined below:

               -  absolute neutrophil count ≥750/mcL

               -  platelets ≥75,000/mcL

               -  total bilirubin < 2.0 x upper limit of normal (ULN)

               -  AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal or 5 X ULN

               -  if due to lymphoma infiltration

               -  creatinine 2.0 X ULN OR

               -  creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels
                  above 2.0 X ULN .

          -  Ability to understand and the willingness to sign a written informed consent
             document.

        Exclusion Criteria:

          -  Participants who have had chemotherapy within 3 weeks, rituximab or obinutuzumab
             within 4 weeks, or radioimmunotherapy within 6 weeks prior to entering the study, or
             those who have not recovered from adverse events due to agents administered more than
             3 weeks earlier. Subjects actively progressing within that window who have recovered
             from toxicities of prior therapy are also eligible.

          -  Autologous stem cell transplantation within 12 weeks prior to study entry

          -  Prior allogeneic transplant

          -  Therapeutic doses of corticosteroids within 14 days prior to study entry, defined as
             >20mg/day pf prednisone, or equivalent. Topical and/or inhaled steroids are
             permitted.

          -  Participants who are receiving any other investigational agents.

          -  Participants with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse
             events.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to blinatumomab

          -  Subjects with known HIV infection

          -  Pregnant or lactating subjects.

          -  Chronic infection with hepatitis B or hepatitis C virus

          -  History of or current relevant CNS pathology such as epilepsy, seizure,
             paresis,aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain
             syndrome, psychosis

          -  Prior history of another malignancy (except for non-melanoma skin cancer, in situ
             cervical or breast cancer, or localized prostate cancer) unless disease free for at
             least one year and felt at low risk of relapse by treating physician.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or
             uncontrolled systemic fungal, bacterial, viral, or other infection, symptomatic
             congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
             psychiatric illness/social situations that would limit compliance with study
             requirements.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate
Time Frame:at completion of treatment (6 months)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival Rate
Time Frame:2 years
Safety Issue:
Description:
Measure:Progression Free Survival Rate
Time Frame:2 years
Safety Issue:
Description:
Measure:Time To Response Rate
Time Frame:2 years
Safety Issue:
Description:
Measure:Duration of Response
Time Frame:2 years
Safety Issue:
Description:
Measure:Rate Patients Are Discontinued From The Drug
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Massachusetts General Hospital

Trial Keywords

  • Lymphoma

Last Updated

February 27, 2017