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Monoclonal Antibodies

rhIL-15 for Sezary Syndrome

Phase 1
Waitlist Available
Led By Kevin C Conlon, 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 from the time the subject began protocol treatment until end of treatment, progression or start of another therapy or approximately 2 years
Awards & highlights

Study Summary

Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies

Eligible Conditions
  • Sezary Syndrome
  • Peripheral T-Cell Lymphoma
  • Anaplastic Lymphoma
  • Mycosis Fungoides

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time the subject began protocol treatment until end of treatment, progression or start of another therapy or approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time the subject began protocol treatment until end of treatment, progression or start of another therapy or approximately 2 years 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 Interleukin 15
Secondary outcome measures
Mean Duration of Response (DOR)
Mean Event-free Survival (EFS)
Mean Overall Survival (OS)
+3 more
Other outcome measures
Number of Participants With Serious and/or 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)

Side effects data

From 2022 Phase 1 trial • 8 Patients • NCT03905135
100%
Alkaline phosphatase increased
50%
Localized edema
50%
Headache
50%
Cough
50%
Fatigue
50%
Fever
50%
Platelet count decreased
50%
Aspartate aminotransferase increased
50%
Edema limbs
50%
Hyponatremia
50%
Infusion related reaction
50%
Neutrophil count decreased
50%
Sinus tachycardia
50%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab

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 cycles 1-6 with avelumab at 10mg/kg on Day 8 and 22 of each cycle
Group II: 1- Experimental Treatment: Dose EscalationExperimental Treatment2 Interventions
Interleukin-15 (IL-15) by continuous intravenous (civ) infusion at escalating doses of 1, 2, 3 and 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with avelumab by intravenous (IV) infusion at a dose of 10mg/kg on Day 8 and 22 of each cycle, to determine maximum tolerated dose (MTD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rhIL-15
2019
Completed Phase 1
~10
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,846 Total Patients Enrolled
89 Trials studying Sezary Syndrome
3,578 Patients Enrolled for Sezary Syndrome
Kevin C Conlon, M.D.Principal InvestigatorNational Cancer Institute (NCI)
10 Previous Clinical Trials
1,060 Total Patients Enrolled
Milos Miljkovic, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
940 Total Patients Enrolled
1 Trials studying Sezary Syndrome
6 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.
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.
Frontiers in ImmunologyJournal
IL-15 in the Combination Immunotherapy of Cancer
Waldmann, Thomas A., Sigrid Dubois, Milos D. Miljkovic, and Kevin C. Conlon. 2020. “IL-15 in the Combination Immunotherapy of Cancer”. Frontiers in Immunology. Frontiers Media SA. doi:10.3389/fimmu.2020.00868.
clinicaltrials.govStudy
Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies
Kevin Conlon, MD 2019. "Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03905135.
~1 spots leftby Apr 2025
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