Mogamulizumab and Extracorporeal Photopheresis for the Treatment of Sezary Syndrome or Mycosis Fungoides

  • STATUS
    Recruiting
  • End date
    Apr 28, 2025
  • participants needed
    32
  • sponsor
    Emory University
Updated on 10 July 2022
systemic disease
cancer
hysterectomy
lymphoma
methotrexate
retinoids
systemic therapy
interferon
bilateral oophorectomy
cytotoxic chemotherapy
vorinostat
human chorionic gonadotropin
neutrophil count
chemotherapy regimen
beta-hcg
immunoglobulin
skin biopsy
t-cell lymphoma
sezary syndrome
romidepsin
extracorporeal photopheresis
mycosis
cutaneous lymphoma
mogamulizumab

Summary

This phase Ib/II trial investigates the side effects of mogamulizumab and extracorporeal photopheresis and to see how well they work in treating patients with Sezary syndrome or mycosis fungoides. Mogamulizumab (a humanized antibody) binds to CCR4, a protein often found in high amounts on T-cell lymphoma cells. Binding to these cells may slow their growth, as well as mark them for attack by the immune system. Extracorporeal photopheresis (ECP) is a standard treatment for cancers that affects the skin, and may work by killing some lymphoma cells directly and by boosting the body's immune response against other lymphoma cells. Giving mogamulizumab together with ECP may work better in treating patients with Sezary syndrome or mycosis fungoides compared to either therapy alone.

Description

PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of the combination of mogamulizumab and ECP in Sezary syndrome (SS) and erythrodermic mycosis fungoides (MF).

II. To determine the efficacy of the combination of mogamulizumab and extra-corporeal photopheresis in SS and erythrodermic MF.

SECONDARY OBJECTIVE:

I. To assess response by disease compartment, time to response, duration of response, progression free survival (PFS), and change in quality of life in patients with Sezary syndrome and erythrodermic MF treated with mogamulizumab and ECP.

TERTIARY/EXPLORATORY OBJECTIVE:

I. To assess biomarkers of response and changes in immunologic response on serial blood samples and peripheral blood flow cytometry.

OUTLINE

INDUCTION (WEEKS 1-7): Patients receive mogamulizumab intravenously (IV) over 60 minutes on days 1, 8, 15, 22, and 36 in the absence of disease progression progression and unacceptable toxicity. Patients also undergo extracorporeal photopheresis on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression and unacceptable toxicity.

TREATMENT (CYCLES 1-12): Patients receive mogamulizumab IV over 60 minutes on days 1 and 15, and undergo extracorporeal photopheresis on days 1 and 15 of cycles 1-6, then day 1 of subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression and unacceptable toxicity.

MAINTENANCE (CYCLES 13+): Patients with clinical benefit may continue extracorporeal photopheresis on day 1. Cycles repeat every 28 days in the absence of disease progression and unacceptable toxicity.

After completion of study treatment, patients are followed up for 90 days, then every 3 months for 3 years.

Details
Condition Mycosis Fungoides, Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Sezary Syndrome
Treatment quality-of-life assessment, Extracorporeal Photopheresis, Mogamulizumab
Clinical Study IdentifierNCT04676087
SponsorEmory University
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Histopathologic diagnosis of primary cutaneous T-cell non-Hodgkin lymphoma (CTCL) (mycosis fungoides [MF] or Sezary syndrome [SS]), confirmed by skin biopsy, or lymph node, or blood assessment, of current disease
CTCL stage 3A-4A2 disease at study entry according to International Society of Cutaneous Lymphoma (ISCL)/European Organization for Research and Treatment of Cancer (EORTC)
Newly diagnosed or =< 3 different lines of systemic therapy
Systemic therapy includes oral retinoids, interferon, pralatrexate, methotrexate, vorinostat, romidepsin, single or multi-agent chemotherapy or other oral, IV or subcutaneous treatments used to treat systemic disease
A line of therapy is defined as any therapy or group of therapies that was started or changed for lack of response, disease progression, or intolerance
Prior cytotoxic chemotherapy excluding low dose methotrexate
A minimum washout period of 4 weeks after previous CTCL therapy is recommended prior to the first dose of combination therapy
Willing and able to comply with all aspects of the protocol
Provide voluntary written informed consent prior to any study specific screening procedures
Absolute neutrophil count (ANC) >= 500/mcL (within 16 days of cycle 1 day 1)
Platelets >= 50,000/mcL (within 16 days of cycle 1 day 1)
Total bilirubin =< 3 institutional upper limit of normal (ULN) (within 16 days of cycle 1 day 1)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5 institutional upper limit of normal (ULN) (within 16 days of cycle 1 day 1)
Not dialysis dependent, creatinine clearance >= 30 mL/min (within 16 days of cycle 1 day 1)
Female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy: documented by negative beta-human chorionic gonadotropin [beta-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 30 Days after completion. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 30 days after completion of study drug administration. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months

Exclusion Criteria

Visceral involvement except for CTCL involvement of the bone marrow
Bulky lymphadenopathy (> 5 cm), or pathologically N3 lymph node involvement
Total skin electron beam therapy within 6 months prior to registration
Prior allogeneic transplantation
Prior mogamulizumab therapy within 6 months of registration or progression or intolerance of mogamulizumab
Patients with 2 or less doses of prior mogamulizumab prior to registration will be eligible regardless of date mogamulizumab was received
Patients who received mogamulizumab pre-study enrollment would restart day 1 dosing per protocol
Prior ECP > 2 months in duration within 3 months of registration
Patients with ECP treatment prior to registration will be eligible regardless of date ECP was received (as long as it was not > 2 months in duration within the 3 months immediately prior to registration), as long as they have measurable disease at the time of enrollment
Use of topical steroids within 14 days of day 1 of initial therapy is not allowed, with the following exception
Topical steroids or systemic low dose steroids (=< 10 mg/day prednisone) are allowed in subjects with erythroderma who have been on corticosteroids for a prolonged period of time and where discontinuation may lead to rebound flare in disease. The concomitant steroid medication is allowed as long as the type of steroid, route of administration, and steroid dose remain the same as what the subject had been receiving for a prolonged period of time
Severe or uncontrolled autoimmune condition
Active, life threatening malignancy (except for CTCL, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix, or other localized malignancies treated with curative intent with surgery or radiation alone) within the past 12 months
Serious intercurrent illness
Known significant cardiac disease requiring ongoing treatment, including congestive heart failure (CHF), severe coronary artery disease (CAD), cardiomyopathy, uncontrolled cardiac arrhythmia, unstable angina pectoris, or myocardial infarction (MI) (within 6 months of study enrollment)
Major surgery within 2 weeks of study enrollment
Significant or uncontrolled infections requiring systemic anti-infective therapy
Patients with human immunodeficiency virus (HIV) infection are eligible. Patients with HIV infection must meet the following: No evidence of co-infection with hepatitis B or C; CD4+ count > 400/mm; no evidence of resistant strains of HIV; on anti-HIV therapy with an HIV viral load < 50 copies HIV RNA/mL. Patients with HIV must have ongoing follow-up with an infectious disease specialist and must have been evaluated within 90 days of cycle 1 day 1
Patients with a history of hepatitis C are eligible as long as the hepatitis C has been treated and cleared and they have no evidence of hepatic dysfunction related to hepatitis C. Patients must have been seen by a hepatologist within 6 months of cycle 1 day 1
Patients who test positive for hepatitis B core antibody may enroll on the study as long as they test negative for both hepatitis B surface antigen and hepatitis B deoxyribonucleic acid (DNA), and if they have no evidence of hepatic dysfunction that is felt to be related to hepatitis B
Patients may not have an auto-immune disease requiring systemic immunosuppression, biologic therapy, and/or steroid use (>= 10 mg daily of prednisone or equivalent)
Patients will not be excluded based on CCR4 expression
Females who are pregnant (positive urine test) or breastfeeding
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note