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Non-hodgkin's LymphomaPhase 1NCT01728207

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

A Phase 1 study testing IMMU-114 in people with Non-hodgkin's Lymphoma and Follicular Lymphoma, run by Gilead Sciences at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMMU-114
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesUnited States
Study dates
Mar 2013to Mar 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43202

  • Indiana University Health Goshen Hospital

    Goshen, Indiana, 46526

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Huntsman Cancer Institute, Univ. Utah

    Salt Lake City, Utah, 84112

  • Nancy N. and J.C. Lewis Cancer and Research Pavilion

    Savannah, Georgia, 31405

Other trials in United States

About this study

Official title: 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.

Being tested
IMMU-114
Keywords
NHL, CLL, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMMU-114Drug

    Also called hL243

    hL243 is a humanized antibody that targets HLA-DR, which is found on various b-cell hematologic malignancies and in autoimmune diseases.

Study groups in NCT01728207
Study groupRoleWhat they receive
IMMU-114ExperimentalIMMU-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.
Receives: Drug: IMMU-114

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: Safety will be assessed by measuring the change from baseline during treatment and up to 30 days after treatment

Secondary outcomes (3)

  1. Clinical Response: o Measured by International Working Group Criteria for NHL patients. o Measured by IWCLL 2008 Guidelines for CLL patients.

    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.

    Measured: Efficacy will be assessed every 12 weeks during treatment and 4 weeks after the end of treatment

  2. Progression Free Survival

    Measured: During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 2 years

  3. Overall Survival

    Measured: During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2012 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2017
  4. Study completionMar 2017

Why it stopped: Study was stopped due to insufficient efficacy and very slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01728207
Sponsor's protocol ID
IMMU-114-01
Status last verified
Mar 2020
First submitted
13 Nov 2012
Last updated
19 Aug 2021
Results posted
No
Data monitoring committee
No

Publications

  • Park KH, Sawada T, Murakami T, Ishii Y, Yasuo M, Fuchinoue S, Goldenberg DM, Kubota K. Anti-class II -DR humanized monoclonal antibody, IMMU-114, blocks allogeneic immune response. Am J Surg. 2012 Oct;204(4):527-34. doi: 10.1016/j.amjsurg.2011.11.017. Epub 2012 Jun 1.

    PubMed 22658578

  • Chen X, Chang CH, Stein R, Goldenberg DM. The humanized anti-HLA-DR moAb, IMMU-114, depletes APCs and reduces alloreactive T cells: implications for preventing GVHD. Bone Marrow Transplant. 2012 Jul;47(7):967-80. doi: 10.1038/bmt.2011.203. Epub 2011 Oct 24.

    PubMed 22020022

  • Rossi EA, Rossi DL, Cardillo TM, Stein R, Goldenberg DM, Chang CH. Preclinical studies on targeted delivery of multiple IFNalpha2b to HLA-DR in diverse hematologic cancers. Blood. 2011 Aug 18;118(7):1877-84. doi: 10.1182/blood-2011-03-343145. Epub 2011 Jun 16.

    PubMed 21680794

  • Stein R, Balkman C, Chen S, Rassnick K, McEntee M, Page R, Goldenberg DM. Evaluation of anti-human leukocyte antigen-DR monoclonal antibody therapy in spontaneous canine lymphoma. Leuk Lymphoma. 2011 Feb;52(2):273-84. doi: 10.3109/10428194.2010.535182. Epub 2010 Dec 6.

    PubMed 21133722

  • Stein R, Gupta P, Chen X, Cardillo TM, Furman RR, Chen S, Chang CH, Goldenberg DM. Therapy of B-cell malignancies by anti-HLA-DR humanized monoclonal antibody, IMMU-114, is mediated through hyperactivation of ERK and JNK MAP kinase signaling pathways. Blood. 2010 Jun 24;115(25):5180-90. doi: 10.1182/blood-2009-06-228288. Epub 2010 Jan 25.

    PubMed 20101022

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMMU-114 in people with Non-hodgkin's Lymphoma and Follicular Lymphoma, run by Gilead Sciences at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study was stopped due to insufficient efficacy and very slow accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01728207, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.

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