Study Comparing Galinpepimut-S to Best Available Therapy for Maintenance in Acute Myeloid Leukemia (AML) in Second Remission
Sponsor: Sellas Life Sciences Group
ClinicalTrials ID:NCT04229979
This clinical trial is evaluating the safety and effectiveness of a new treatment, galinpepimut-S (GPS), compared to the best available therapy chosen by doctors, for patients with acute myeloid leukemia (AML) who are in their second complete remission or have incomplete platelet recovery.
Patient Parameters
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Program Overview
The study aims to determine if galinpepimut-S (GPS) can improve overall survival in patients with acute myeloid leukemia (AML) who are in their second complete remission (CR2) or have incomplete platelet recovery (CRp2). Patients will be randomly assigned to receive either GPS or the best available therapy (BAT) as chosen by their doctor. The study will involve about 140 patients across 110 sites. The main goal is to see if GPS helps patients live longer compared to the other treatments.
Description
This study involves two groups of patients with AML in their second remission. One group will receive galinpepimut-S (GPS), and the other will receive the best available therapy (BAT) as chosen by their doctor. The study will compare the overall survival rates between these two groups.
Patients in the GPS group will receive a series of injections over time, starting with an initial phase of treatment every two weeks, followed by booster phases every four to six weeks. Patients who continue to be in remission will receive ongoing treatment every two to three months.
Patients in the BAT group may receive different treatments, including observation, certain chemotherapy drugs, or other medications as determined by their doctor. Patients who can maintain remission with specific targeted therapies will not be eligible for this study.
All patients will have regular check-ups, including bone marrow tests, to monitor their health and the effectiveness of the treatment. The study will track overall survival as the primary outcome.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older and able to provide informed consent.
- Diagnosed with acute myeloid leukemia (AML) and currently in second complete remission (CR2) or with incomplete platelet recovery (CRp2).
- Not eligible for a stem cell transplant due to medical reasons, personal choice, or lack of a donor.
- Must have completed previous AML treatment at least four weeks prior to starting the study.
- Must have a life expectancy of more than six months.
- Women must not be pregnant and must agree to use contraception during the study.
- Must have adequate liver and kidney function and meet specific blood count requirements.
- Must be willing to return for follow-up visits and comply with study requirements.
Exclusion Criteria
- Cannot continue any previous AML treatments while on the study.
- Cannot have had a significant allergic reaction to certain medications used in the study.
- Cannot have received certain treatments or vaccines shortly before starting the study.
- Cannot have other serious illnesses or conditions that would interfere with the study.
- Cannot be pregnant or breastfeeding.
- Cannot have had a recent stem cell transplant or be planning one soon.
- Cannot have active infections or other cancers that require treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| O'Neal Comprehensive Cancer Center | 35205 | Birmingham | Alabama |
| UCLA Medical Hematology and Oncology | 90095 | Los Angeles | California |
| The Oncology Institute of Hope and Innovation | 90603 | Whittier | California |
| Colorado Blood Cancer Institute - SCRI - PPDS | 80218 | Denver | Colorado |
| Mayo Clinic Jacksonville Florida | 32224 | Jacksonville | Florida |
| Augusta University | 30912 | Augusta | Georgia |
| Rush University Cancer Center | 60612 | Chicago | Illinois |
| Tulane Cancer Center - Liberty | 70112 | New Orleans | Louisiana |
| Northwell Health Cancer Institute | 11042 | Lake Success | New York |
| New York Medical College | 10532 | Valhalla | New York |
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