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Cutaneous T Cell Lymphoma (CTCL)Phase 2NCT02542124

NM-IL-12 in Cutaneous T-Cell Lymphoma (CTCL) Undergoing Total Skin Electron Beam Therapy (TSEBT)

A Phase 2 study testing NM-IL-12 and TSEBT in people with Cutaneous T Cell Lymphoma (CTCL) and Mycosis Fungoides, run by Neumedicines Inc. at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In the proposed study, NM-IL-12 will be evaluated as immunotherapy to increase antitumor efficacy against CTCL, while reducing skin-related toxicity, when combined with low-dose TSEBT therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NM-IL-12 and TSEBT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesUnited States
Study dates
Dec 2015to May 2019
Phase
Phase 2
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

  • 18 years of age or older
  • Biopsy-confirmed CD4+ mycosis fungoides or Sézary syndrome, stage IB to IIIB
  • The patient is eligible for TSEBT
  • Eastern Cooperative Oncology Group (ECOG) of ≤ 2.
  • Adequate bone marrow function: WBC > 2000/μL; platelet count > 75,000/μL; Neutrophil count > 1000/μL, without use of colony stimulating factors (CSF).
  • Required washout period for prior therapies Topical therapy: 2 weeks
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  • Phototherapy (PUVA): 4 weeks
  • Local Skin Radiation Therapy (< 10% skin surface): 4 weeks
  • Retinoids: 4 weeks
  • Interferons: 4 weeks
  • Low dose methotrexate: 4 weeks
  • HDAC inhibitors: 8 weeks
  • Women of child-bearing potential must have negative serum pregnancy test and use accepted highly effective methods of birth control throughout the study and for 90 days after dosing and must agree to use effective contraception.
  • Male patients must be willing to use an appropriate method of contraception (e.g., condoms) or abstain from sexual intercourse and inform any sexual partners that they must also use a reliable method of contraception during the study and for 90 days after dosing.
  • Adequate hepatic function: bilirubin ≤1.5 x upper limit of normal (ULN), AST ≤2.5 x ULN, ALT ≤2.5 x ULN, alkaline phosphatase (liver fraction) ≤2.5 x ULN
  • Adequate renal function: creatinine ≤1.5 x ULN
  • Ability to comply with the treatment schedule

Who cannot join

  • Biopsy confirmed CD8+ CTCL histology
  • Large cell transformation
  • Prior systemic use of any immunosuppressive chemotherapy (except low dose methotrexate) and/or monoclonal antibody treatment for CTCL
  • Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study).
  • Concomitant use of any anti-cancer therapy or immune modifier.
  • Prior allogeneic hematopoietic cell transplant.
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  • Any ongoing infection whether receiving or not receiving antibiotics or have received intravenous antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug.
  • Known history of human immunodeficiency virus (HIV), hepatitis B or C
  • For women on estrogen based contraceptives, family history of venous thromboembolism (VTE) and/or risk factors predisposing for VTE and other medical conditions known to be associated with VTE.
  • History of prior malignancy with the exception of cervical intraepithelial neoplasia, non-melanoma skin cancer, and adequately treated localized prostate carcinoma (PSA <1.0). Patients with a history of other malignancies must have undergone potentially curative therapy and have no evidence of that disease for five years
  • Uncontrolled intercurrent illness, condition, or circumstances that could limit compliance with the study, including, but not limited to the following: acute or chronic graft versus host disease, uncontrolled diabetes mellitus or hypertension, or psychiatric conditions
  • Any other medical issue, including laboratory abnormalities, deemed by the Investigator to be likely to interfere with patient participation
  • Unresolved toxicity from previous anticancer therapy or incomplete recovery from surgery
  • Major surgery within 12 weeks of enrolment
  • Medically significant cardiac event or unstable cardiovascular function defined as:
  • Symptomatic ischemia, unstable angina pectoris
  • Uncontrolled clinically significant cardiac arrhythmia
  • Symptomatic heart failure NYHA Class ≥ 3
  • Myocardial infarction or cardiac surgery within 6 months prior to enrollment
  • Cerebrovascular event (transient ischemic attack, stroke or CNS bleeding) within the last 12 months.
  • Major bleeding within the last 6 months.
  • Use of any investigational agents within 30 days prior to enrollment and for the duration of the study
  • Pregnant or lactating
  • Unwilling or unable to provide informed consent

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Stanford Cancer Center

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Single Arm, Open-Label Study To Evaluate The Safety, Tolerability And Preliminary Efficacy Of NM-IL-12 (rHuIL-12) In Patients With Cutaneous T Cell Lymphoma (CTCL) Undergoing Low Dose Total Skin Electron Beam Therapy (TSEBT)

In the proposed study, NM-IL-12 will be evaluated as immunotherapy to increase antitumor efficacy against CTCL, while reducing skin-related toxicity, when combined with low-dose TSEBT therapy. Determination of the maximum tolerated dose (MTD) for NM-IL-12 is not planned in this study, rather, a pre-defined starting dose will be explored; this dose is based on two safety and tolerability studies of NM-IL-12 in healthy volunteers.

Read the detailed description

This is a single arm, open-label, non-randomized study with NM-IL-12 dosed in combination with low dose TSEBT in CTCL patients. This study is planned to be conducted in 10 patients, 18 years or older in age, undergoing low dose TSEBT of 12 Gy over a 3-week period.

The study will initially enroll 4 patients and then will be expanded to enroll 6 additional patients (total 10 patients) depending on the presence or absence of Dose Modifying Criteria (DMC). Decision whether to de-escalate will be made after first 4 patients are followed up for 28 days from the first dose of NM-IL-12.

Safety monitoring will continue throughout the whole period of drug administration and the treatment will be discontinued if intolerable toxicity or disease progression occurs during this period.

Being tested
NM-IL-12 and TSEBT
Keywords
CTCL, Total Skin Electron Beam Therapy (TSEBT), Mycosis fungoides, Sézary syndrome, recombinant human Interleukin-12 (rHuIL-12), T Cell
Medical subject headings
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

What participants receive

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

  • NM-IL-12 and TSEBTBiological

    Also called HemaMax, rHu-IL12, LD-TSEBT

    The LD-TSEBT treatment will start on Day 1 of the study. NM-IL-12 will be administered subcutaneously.

Study groups in NCT02542124
Study groupRoleWhat they receive
NM-IL-12 and TSEBTExperimentalTSEBT and subcutaneous doses of NM-IL-12
Receives: Biological: NM-IL-12 and TSEBT

What is being measured

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

  1. Safety and tolerability will be evaluated on the basis of the following parameters (Vital signs, physical examination,Toxicity according to the NCI CTCAE, Immunogenicity evaluated by the presence of anti-drug antibody) :

    General safety: Vital signs (temperature, blood pressure, pulse rate, respiratory rate) and physical examination.

    Toxicity according to the NCI CTCAE (v4.03) for AEs and clinical laboratory profile; AEs will be collected in all patients who received at least one dose of NM-IL-12 and up to four weeks post last NM-IL-12 dose.

    Immunogenicity of NM-IL-12 will be evaluated by the presence of anti-drug antibody (ADA)

    Measured: 107 weeks

Secondary outcomes (2)

  1. Clinical Response measured by a modified severity-weighted assessment tool (mSWAT)

    Exploratory skin clinical responses measured by a modified severity-weighted assessment tool (mSWAT)

    Measured: 107 weeks

  2. Progression free survival

    Progression free survival based on every 4 week follow up after the monthly dose until one of the events below occurs first:

    • Progressive disease is documented
    • Another treatment for CTCL is administered (topical or systemic)
    • 107 weeks are completed after the patient's first dose of NM-IL-12

    Measured: 107 weeks

Timeline

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

  1. First posted4 Sep 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionFeb 2019 (estimated)
  4. Study completionMay 2019 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02542124
Sponsor's protocol ID
NM-ONC-001
Other IDs
1R44CA192576-01
Status last verified
Nov 2018
First submitted
1 Sep 2015
Last updated
16 Nov 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Gokhale MS, Vainstein V, Tom J, Thomas S, Lawrence CE, Gluzman-Poltorak Z, Siebers N, Basile LA. Single low-dose rHuIL-12 safely triggers multilineage hematopoietic and immune-mediated effects. Exp Hematol Oncol. 2014 Apr 11;3(1):11. doi: 10.1186/2162-3619-3-11.

    PubMed 24725395

  • Gluzman-Poltorak Z, Vainstein V, Basile LA. Recombinant interleukin-12, but not granulocyte-colony stimulating factor, improves survival in lethally irradiated nonhuman primates in the absence of supportive care: evidence for the development of a frontline radiation medical countermeasure. Am J Hematol. 2014 Sep;89(9):868-73. doi: 10.1002/ajh.23770. Epub 2014 Jun 19.

    PubMed 24852354

  • Gluzman-Poltorak Z, Mendonca SR, Vainstein V, Kha H, Basile LA. Randomized comparison of single dose of recombinant human IL-12 versus placebo for restoration of hematopoiesis and improved survival in rhesus monkeys exposed to lethal radiation. J Hematol Oncol. 2014 Apr 6;7:31. doi: 10.1186/1756-8722-7-31.

    PubMed 24708888

  • Basile LA, Ellefson D, Gluzman-Poltorak Z, Junes-Gill K, Mar V, Mendonca S, Miller JD, Tom J, Trinh A, Gallaher TK. HemaMax, a recombinant human interleukin-12, is a potent mitigator of acute radiation injury in mice and non-human primates. PLoS One. 2012;7(2):e30434. doi: 10.1371/journal.pone.0030434. Epub 2012 Feb 24.

    PubMed 22383962

  • Rook AH, Wood GS, Yoo EK, Elenitsas R, Kao DM, Sherman ML, Witmer WK, Rockwell KA, Shane RB, Lessin SR, Vonderheid EC. Interleukin-12 therapy of cutaneous T-cell lymphoma induces lesion regression and cytotoxic T-cell responses. Blood. 1999 Aug 1;94(3):902-8.

    PubMed 10419880

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NM-IL-12 and TSEBT in people with Cutaneous T Cell Lymphoma (CTCL) and Mycosis Fungoides, run by Neumedicines Inc. at 3 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 17 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

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?

Safety and tolerability will be evaluated on the basis of the following parameters (Vital signs, physical examination,Toxicity according to the NCI CTCAE, Immunogenicity evaluated by the presence of anti-drug antibody) : (time frame: 107 weeks). 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 NCT02542124, 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 16 Nov 2018.

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