Health TrialsbyHealthPanel

Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma

ConditionsFolliculotropic Mycosis FungoidesPrimary Cutaneous T-Cell Non-Hodgkin LymphomaSezary SyndromeStage IB Mycosis Fungoides and Sezary Syndrome AJCC v8Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8Transformed Mycosis Fungoides
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

This phase II trial studies the effect of extracorporeal photopheresis (ECP) and mogamulizumab in treating patients with erythrodermic cutaneous T cell lymphoma (CTCL), a type of skin lymphoma. CTCL is a rare type of cancer that begins in the white blood cells called T cells. Erythrodermic is a widespread red rash that may cover most of the body. ECP is a medical treatment that removes blood with a machine, isolates white blood cells and exposes them to ultra violet light, then returns the cells to the body. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving mogamulizumab with ECP may work together to kill the tumor cells directly (with mogamulizumab) and boost immune response to cancer (with ECP).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guideline

Agreement to allow the use of archival tissue from diagnostic tumor biopsies

If unavailable, exceptions may be granted with study principal investigator (PI) approval

Disqualifiers

Prior mogamulizumab

Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy

Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy

Any skin-directed therapy within 14 days prior to initiating protocol therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • Extracorporeal Photopheresis

    Procedure/Surgery

    Undergo ECP

  • Mogamulizumab

    Biological/Vaccine

    Given IV

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Treatment (ECP, mogamulizumab)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

ORR will be calculated as the proportion of evaluable patients that have confirmed complete response (CR) or partial response (PR), as defined according to global response assessment. Exact 95% confidence intervals will be calculated for these estimates.

Time frame
Up to 1 year post treatment
2

Incidence of adverse events

Toxicity and adverse events will be recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events 5.0 scale. Observed toxicities will be summarized by type, severity, date of onset, and attribution.

Time frame
Up to cycle 3 (each cycle = 28 days)

Secondary outcomes

1

Complete response rate

Defined as the proportion of response-evaluable patients that have a documented CR.

Time frame
Up to 1 year post treatment
2

Time to response

Will be estimated using the product-limit method of Kaplan and Meier.

Time frame
From initiation of study therapy to the first achievement of CR or PR, assessed up to 1 year
3

Duration of response

Will be estimated using the product-limit method of Kaplan and Meier.

Time frame
From the first achievement of PR or CR to time of partial disease or death, assessed up to 1 year
4

Progression-free survival

Will be estimated using the product-limit method of Kaplan and Meier.

Time frame
From initiation of study therapy to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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