Mogamulizumab for Cutaneous T-Cell Lymphoma

Recruiting at 20 trial locations

Overseen By Kyowa Kirin, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kyowa Kirin, Inc.

Disqualifiers: Large cell transformation, Allogeneic transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 104 weeks

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called mogamulizumab in adults with certain types of skin cancer that have come back or not responded to other treatments. The medication helps the immune system find and destroy cancer cells. Mogamulizumab is approved for treating various types of skin cancer.

Eligibility Criteria

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.

Inclusion Criteria

My cancer is at a late stage and I've had at least one treatment that didn't work.

My diagnosis of mycosis fungoides or Sézary syndrome is confirmed by tissue analysis.

Exclusion Criteria

I have been treated with mogamulizumab before.

I have had a transplant from a donor.

Current evidence of large cell transformation;

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive mogamulizumab weekly during induction, then every 4 weeks for up to 2 years

Up to 104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 7 months

Treatment Details

Interventions

• Mogamulizumab

Trial Overview 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.

Participant Groups

Group I: Mogamulizumab Experimental Treatment 1 Intervention

Mogamulizumab is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Poteligeo for:

• Mycosis fungoides
• Sézary syndrome

Approved in United States as Poteligeo for:

• Mycosis fungoides
• Sézary syndrome

Approved in Canada as Poteligeo for:

• Mycosis fungoides
• Sézary syndrome

Approved in Japan as Poteligeo for:

• Adult T-cell leukemia-lymphoma
• Cutaneous T-cell lymphoma

Who Is Running the Clinical Trial?

Kyowa Kirin, Inc.

Lead Sponsor

Trials

49

Recruited

5,700+