Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03422627
Phase: Phase I/II
Principal Investigator: Pidala, Joseph
A Phase 1b/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 592 in Adult Subjects With Steroid Refractory Chronic Graft versus Host Disease
The purpose of Phase 1b is to evaluate the safety and tolerability of multiple ascending doses of efavaleukin alfa in participants with steroid refractory cGVHD. The purpose of Phase 2 is to evaluate the efficacy of efavaleukin alfa in participants with steroid refractory cGVHD as measured by ORR at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria.
Primary: Phase 1b : To evaluate the safety and tolerability of multiple ascending doses of AMG 592 in subjects with steroid refractory cGVHD in order to estimate the MTD and establish the RP2D. Phase 2 :To evaluate the efficacy of AMG 592 in subjects with steroid refractory cGVHD as measured by the best overall response rate (ORR) during the study according to the 2014 cGVHD National Institutes of Health (NIH) Consensus Criteria. Secondary: Phase 1b :To evaluate the immunologic effects of AMG 592 including fold change from baseline in regulatory T cell (Treg), conventional T cell (Tcon), and NK cell numbers (cells/ìL) and the Treg/Tcon ratio. To characterize the PK profile following multiple ascending subcutaneous (SC) dose administrations of AMG 592. To evaluate the incidence of anti-AMG 592 antibody formation and cross-reactivity to native human interleukin-2 (IL-2). Phase 2: To evaluate the safety and tolerability of AMG 592 as measured by the occurrence of treatment-emergent adverse events. To evaluate ORR, as defined by 2014 cGVHD NIH Consensus Criteria at various timepoints in AMG 592- treated subjects. To evaluate failure free survival (FFS), defined as absence of relapse, death, or need for additional systemic immunosuppressant cGVHD therapy. To evaluate systemic steroid use. To evaluate changes in symptom burden as measured by the Lee Symptom Scale. To measure changes in quality of life as measured by Short Form Health Survey 36 version 2 (SF36v2) and Karnofsky performance status. To evaluate the PK of AMG 592. To evaluate the incidence of anti-AMG 592 antibody formation and cross reactivity to human IL-2.
Therapy (NOS)
AMG 592 ()
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
Back to top
Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.
NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.
REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.
Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.
Moffitt Cancer Center is committed to the health and safety of our patients and their families. For more information on how we’re protecting our new and existing patients, visit our COVID-19 Info Hub
Our patient services specialists can assist you with scheduling an appointment, questions about medical records, insurance, billing and more.
Patient Appointment Center Hours: 7 a.m. to 7 p.m. Monday - Friday; 8 a.m. to noon Saturday