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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02811679
Collaborator
Amgen (Industry)
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Jan 27, 2020
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Blinatumomab

Blinatumomab 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.

Drug: Blinatumomab
Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
Other Names:
  • Blincyto
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate [at completion of treatment (6 months)]

    Secondary Outcome Measures

    1. Overall Survival Rate [2 years]

    2. Progression Free Survival Rate [2 years]

    3. Time To Response Rate [2 years]

    4. Duration of Response [2 years]

    5. Rate Patients Are Discontinued From The Drug [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts general Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • Amgen

    Investigators

    • Principal Investigator: Jeffrey Barnes, MD, PhD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeffrey Barnes, MD PhD, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT02811679
    Other Study ID Numbers:
    • 16-118
    First Posted:
    Jun 23, 2016
    Last Update Posted:
    Feb 3, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Jeffrey Barnes, MD PhD, Massachusetts General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 3, 2021