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Monoclonal Antibodies

Mogamulizumab for Cutaneous T-Cell Lymphoma

Phase 2
Waitlist Available
Research Sponsored by Kyowa Kirin, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage IB, II-A, II-B, III, or IV;Participants who have failed at least one prior course of systemic therapy (e.g., interferon, bexarotene, photopheresis, anti-neoplastic chemotherapy). Psoralen plus ultraviolet light therapy (PUVA) is not considered a systemic therapy.
Histologically confirmed diagnosis of MF or SS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of consent, at every treatment and follow up visit, up to 27 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and works well against mycosis fungoides and Sézary syndrome, two types of cutaneous T-cell lymphoma.

Who is the study for?
This trial is for adults with certain types of skin lymphoma (CTCL) who have tried at least one systemic therapy without success. It's not open to those who've had a specific cell transformation, previous mogamulizumab treatment, or an allogeneic transplant.Check my eligibility
What is being tested?
The study tests the safety and effects of mogamulizumab given every four weeks after initial weekly doses in patients with relapsed/refractory mycosis fungoides (MF) and Sézary syndrome (SS), which are subtypes of CTCL.See study design
What are the potential side effects?
Mogamulizumab may cause side effects such as skin reactions, infusion-related symptoms, fatigue, infections due to immune system suppression, and potentially serious allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is at a late stage and I've had at least one treatment that didn't work.
Select...
My diagnosis of mycosis fungoides or Sézary syndrome is confirmed by tissue analysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of consent, at every treatment and follow up visit, up to 27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of consent, at every treatment and follow up visit, up to 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number, percentage and severity of treatment emergent adverse events

Side effects data

From 2023 Phase 1 & 2 trial • 8 Patients • NCT03309878
100%
Hypotension
100%
Alanine aminotransferase increased
100%
Infusion related reaction
100%
Lightheaded
100%
Hyponatremia
100%
Alkaline phosphatase increased
100%
Acidosis
100%
Aspartate aminotransferase increased
100%
Hyperuricemia
100%
Neutrophil count decreased
100%
Platelet count decreased
100%
Sinus tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I Dose Level -1
Phase I Dose Level 1

Trial Design

1Treatment groups
Experimental Treatment
Group I: MogamulizumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mogamulizumab
2016
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Kyowa Kirin, Inc.Lead Sponsor
47 Previous Clinical Trials
5,687 Total Patients Enrolled

Media Library

Mogamulizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04745234 — Phase 2
Cutaneous T-Cell Lymphoma Research Study Groups: Mogamulizumab
Cutaneous T-Cell Lymphoma Clinical Trial 2023: Mogamulizumab Highlights & Side Effects. Trial Name: NCT04745234 — Phase 2
Mogamulizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04745234 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on participant numbers for this research investigation?

"Kyowa Kirin, Inc. is responsible for recruiting 33 suitable participants to partake in the study across two different sites - Yale Cancer Center of New Haven and Tulane University School of Medicine in Louisiana."

Answered by AI

Has Mogamulizumab been certified for general usage by the Food and Drug Administration?

"Taking into account the fact this is a Phase 2 trial, with evidence of safety but not efficacy, our team at Power assigned mogamulizumab a score of 2 on their rating scale."

Answered by AI

In what areas can participating individuals access this research?

"This clinical trial is actively welcoming participants at Yale Cancer Center (New Haven, Connecticut), Tulane University School of Medicine (New Orleans, Louisiana) and Roswell Park Comprehensive Cancer Centre (Buffalo New york). Additionally, 10 other sites are accepting patients."

Answered by AI

Is this examination currently looking for participants?

"Affirmative. Clinicaltrials.gov corroborates that, since its posting on August 16th 2021, this medical study has been actively recruiting patients from 10 different sites with a total goal of 33 participants."

Answered by AI

Have any other investigations explored the efficacy of Mogamulizumab?

"As of now, 10 clinical studies are underway concerning mogamulizumab. None have reached Phase 3 status yet; however, 48 locations in the United States host trials for this medication with Bethesda being a major hub."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mogamulizumab Q4week Dosing in Participants With R/R CTCL
2021. "Mogamulizumab Q4week Dosing in Participants With R/R CTCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04745234.
~9 spots leftby May 2025
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