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

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ClinicalTrials.gov Identifier: NCT02811679
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Jeffrey Barnes, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma Drug: Blinatumomab 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
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 : August 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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 Name: Blincyto




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: at completion of treatment (6 months) ]

Secondary Outcome Measures :
  1. Overall Survival Rate [ Time Frame: 2 years ]
  2. Progression Free Survival Rate [ Time Frame: 2 years ]
  3. Time To Response Rate [ Time Frame: 2 years ]
  4. Duration of Response [ Time Frame: 2 years ]
  5. Rate Patients Are Discontinued From The Drug [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811679


Contacts
Contact: Jeffrey Barnes, MD, PhD 617-724-4000

Locations
United States, Massachusetts
Massachusetts general Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeffrey Barnes, MD PhD    617-724-4000      
Principal Investigator: Jeffrey Barnes, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Amgen
Investigators
Principal Investigator: Jeffrey Barnes, MD, PhD Massachusetts General Hospital

Responsible Party: Jeffrey Barnes, MD PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02811679     History of Changes
Other Study ID Numbers: 16-118
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeffrey Barnes, Massachusetts General Hospital:
Lymphoma

Additional relevant MeSH terms:
Blinatumomab
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Bispecific
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs