Phase I Dose Escalation Study of IMMU-114 in Relapsed or Refractory NHL and CLL

August 12, 2021 updated by: Gilead Sciences

A Phase I Dose Escalation Study of Immunotherapy With IMMU-114 in Patients With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

IMMU-114 will be studied at different dose schedules and dose levels in order to assess the highest dose safely tolerated. IMMU-114 will be administered subcutaneously (under the skin). IMMU-114 will be given 1-2 times weekly for 3 weeks followed by one week of rest. This is considered one cycle. Treatment cycles will be repeated until toxicity or worsening of disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Helen F Graham Cancer Center
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Nancy N. and J.C. Lewis Cancer and Research Pavilion
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Indiana University Health Goshen Hospital
    • Ohio
      • Columbus, Ohio, United States, 43202
        • The Ohio State University Comprehensive Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute, Univ. Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Each patient with CLL/SLL must meet all of the following inclusion criteria to be enrolled on the study:
  • Patients must have met the diagnostic criteria for CLL/SLL according to the IWCLL 2008 [13] or WHO Guidelines at some point during their disease course:
  • Patients with SLL: tumor biopsy immunohistochemistry diagnostic of SLL or blood/bone marrow immunophenotype similar to CLL without lymphocytosis and enlarged lymph nodes.
  • Patient must have relapsed or refractory CLL/SLL following at least one purine analog-containing regimen (or after one non-purine analog containing regimen if there is a relative contraindication to purine-analog containing therapy) and not have traditional options available or decline these. Patients with prolymphocytic leukemia (PLL)-CLL or PLL transformation of CLL are eligible.
  • Patients must meet IWCLL 2008 Guideline [13] criteria for active disease requiring treatment.

Each patient with NHL must meet all of the following inclusion criteria to be enrolled on the study:

  • Patients with histologically confirmed B-cell NHL including marginal zone lymphoma, follicular lymphoma, or mantle cell lymphoma by WHO criteria.
  • Patients must have relapsed or refractory disease after at least one prior therapy and not have traditional options available or decline these.

All patients must meet all of the following inclusion criteria to be enrolled on the study:

  • Age ≥ 18 years
  • Able to understand and sign a written informed consent document.
  • Able to receive outpatient treatment and follow-up at the treating institution.
  • ECOG performance status 0-1.
  • Relapsed/refractory to at least one prior standard systemic treatment regimen, but no more than 4.
  • Completed all prior therapies (immunosuppressive medications, antineoplastic therapy, vaccination, immunotherapy, chemotherapy, radiotherapy, major surgery, etc) >4 weeks prior to the first study dose of medication (alemtuzumab ≥ 6 months).
  • If receiving corticosteroids, ≤ 20 mg/day prednisone or equivalent and unchanged
  • Patients capable of reproduction and male patients who have partners capable of reproduction must agree to use an effective contraceptive method during the course of the study and for 2 months following the completion of their last treatment.
  • Females of childbearing potential must have a negative serum β-Hcg pregnancy test result within 7 days of first study dose. Female patients who are surgically sterilized or who are > 45 years old and have not experienced menses for > 2 years may have β- Hcg pregnancy test waived.
  • Required baseline laboratory data
  • Platelet count ≥ 75,000/mm3
  • Absolute neutrophil count (ANC) ≥ 1500/mm3
  • AST/ALT ≤ 2.5 times upper limit of normal (ULN)
  • Creatinine and total bilirubin ≤ 1.5 times ULN

Exclusion Criteria:

  • Patients having received anti-CD20 therapy ≤ 4 weeks prior to the first study dose.
  • Patients having received alemtuzumab (anti-CD52) therapy ≤ 6 months prior to the first study dose.
  • Patients having undergone prior allogeneic stem cell transplantation within 6 months or having active graft versus host disease.
  • Patients with active Richter's syndrome (>10% large B-cells in marrow).
  • Patients that have been designated Class III or IV by the New York Heart Association Functional Classification.
  • Patients with a history of myocardial infarction or stroke within the last 6 months
  • Patients with transfusion-dependent anemia.
  • Patients with known hypersensitivity to any excipient contained in the drug formulation.
  • Patients with a history of documented human anti-globulin antibodies.
  • Patients with active viral, bacterial or systemic fungal infection requiring treatment.
  • Patients who are known to be HIV or hepatitis C positive.
  • Patients with a history of prior secondary malignancy that requires active systemic therapy that will interfere with interpretation of efficacy or toxicity of IMMU-114, or limit survival to 2 years. These patients should be discussed with the sponsor prior to enrollment. Patients with basal or squamous skin carcinoma, cervical carcinoma in situ on biopsy, localized breast cancer requiring hormonal therapy or localized prostate cancer (Gleason score < 5) do not require discussion.
  • Patients with active known CNS lymphoma. Patients with history of CNS leukemia now in remission are eligible for the trial.
  • Patients who are pregnant or breast-feeding.
  • Patients with major surgery or radiation therapy within 4 weeks prior to first study dose.
  • Patients must have recovered all toxicities from prior therapy or radiation to grade 1 or less (excluding alopecia).
  • Patients with substance abuse or other medical or psychiatric conditions that, in the opinion of the investigator, would confound study interpretation or affect the patient's ability to tolerate or complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMMU-114
IMMU-114 will be administered subcutaneously (under the skin) once or twice weekly for 3 weeks followed by one week of rest. Treatment cycles will continue until disease worsening or toxicity. Various dose levels will be studied.
Drug: IMMU-114
hL243 is a humanized antibody that targets HLA-DR, which is found on various b-cell hematologic malignancies and in autoimmune diseases.
Other Names:
  • hL243

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: Safety will be assessed by measuring the change from baseline during treatment and up to 30 days after treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety will be assessed by measuring the change from baseline during treatment and up to 30 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Response: o Measured by International Working Group Criteria for NHL patients. o Measured by IWCLL 2008 Guidelines for CLL patients.
Time Frame: Efficacy will be assessed every 12 weeks during treatment and 4 weeks after the end of treatment
Responders will be defined as those with complete response (CR) or partial response (PR). Overall response rate (ORR) will be calculated as the number of evaluable responders divided by the total number of evaluable patients.
Efficacy will be assessed every 12 weeks during treatment and 4 weeks after the end of treatment
Progression Free Survival
Time Frame: During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 2 years
During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 2 years
Overall Survival
Time Frame: During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 2 years
During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 19, 2012

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMMU-114-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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