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Monoclonal Antibodies

Mogamulizumab for Sezary Syndrome

Phase 1

Waitlist Available

Led By Milos Miljkovic, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year

Awards & highlights

Study Summary

This trial will test if the drugs IL-15 and mogamulizumab are safe and effective to treat people with ATLL or MF/SS.

Eligible Conditions

Adult T-Cell Leukemia/Lymphoma
Sezary Syndrome
Mycosis Fungoides

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin 15 (IL-15) (rhIL-15)

Number of Grade 1-4 Treatment Related Adverse Events

Secondary outcome measures

Event Free Survival

Number of Participants Overall Response

Progression-free Survival

Other outcome measures

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Number of Participants With a Dose-limiting Toxicity (DLT) Possibly, Probably or Definitely Related to Interleukin 15 (IL-15) or Mogamulizumab.

Side effects data

From 2023 Phase 1 & 2 trial • 8 Patients • NCT03309878

100%

Alanine aminotransferase increased

100%

Lightheaded

100%

Hyponatremia

100%

Alkaline phosphatase increased

100%

Hypotension

100%

Infusion related reaction

100%

Acidosis

100%

Aspartate aminotransferase increased

100%

Hyperuricemia

100%

Neutrophil count decreased

100%

Platelet count decreased

100%

Sinus tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

Phase I Dose Level -1

Phase I Dose Level 1

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2- Experimental Treatment: Dose ExpansionExperimental Treatment2 Interventions

Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at the maximum tolerated dose (MTD) on days 1- 5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kgdays 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle.

Group II: 1- Experimental Treatment: Dose EscalationExperimental Treatment2 Interventions

Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at escalating doses of 2 and 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kgdays 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Recombinant human Interleukin-15 (rhIL-15)

2020

Completed Phase 1

~10

Mogamulizumab

2016

Completed Phase 2

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,664 Previous Clinical Trials

40,926,127 Total Patients Enrolled

89 Trials studying Sezary Syndrome

3,580 Patients Enrolled for Sezary Syndrome

Milos Miljkovic, M.D.Principal InvestigatorNational Cancer Institute (NCI)

6 Previous Clinical Trials

942 Total Patients Enrolled

1 Trials studying Sezary Syndrome

8 Patients Enrolled for Sezary Syndrome

Frequently Asked Questions

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

What key goals are being sought through this experiment?

"This 28-day trial seeks to identify the Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin 15 (IL-15) (rhIL-15). Secondary objectives include obtaining an overall response rate, progression-free survival, and event free survival with 95% confidence intervals."

Answered by AI

Is this trial enrolling new participants currently?

"This clinical trial, which was originally posted on February 26th 2020 and updated most recently in November 23rd of 2022, is not currently searching for participants. However, there are 2 697 other studies that are actively recruiting patients at the present moment."

Answered by AI

Has Mogamulizumab been tested in other clinical trials?

"Currently, there are 10 clinical trials involving Mogamulizumab. None of them have reached Phase 3 yet. Most of the studies for this medication are based in Bethesda, Maryland; however, other 48 sites around the country also offer it as a treatment option."

Answered by AI

Has Mogamulizumab been sanctioned by the FDA?

"From our research at Power, mogamulizumab received a score of 1 due to the limited data available surrounding its efficacy and safety."

Answered by AI

How many individuals are included in the sample size of this research endeavor?

"No, this particular clinical trial has concluded its recruitment of patients. Originally posted on February 26th 2020 and last modified November 23rd 2022, the study is now closed to enrollment. Nonetheless, there are still 2,687 medical studies searching for participants with mycosis fungoides and 10 trials centered around mogamulizumab actively recruiting new members."

Answered by AI

Recent research and studies

Journal for ImmunoTherapy of CancerJournal

Short-course IL-15 Given as a Continuous Infusion Led to a Massive Expansion of Effective NK Cells: Implications for Combination Therapy with Antitumor Antibodies

Dubois, Sigrid P, Milos D Miljkovic, Thomas A Fleisher, Stefania Pittaluga, Jennifer Hsu-Albert, Bonita R Bryant, Michael N Petrus, et al.. 2021. “Short-course IL-15 Given as a Continuous Infusion Led to a Massive Expansion of Effective NK Cells: Implications for Combination Therapy with Antitumor Antibodies”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2020-002193.

clinicaltrials.govStudy

Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome

Kevin Conlon, MD 2020. "Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04185220.