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Cancer Vaccine
Galinpepimut-S for Acute Myeloid Leukemia (REGAL Trial)
Phase 3
Waitlist Available
Research Sponsored by Sellas Life Sciences Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3
Must be in second morphological complete remission (with or without platelet recovery)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6, 9, and 12 months
Awards & highlights
REGAL Trial Summary
This trial is testing a new drug to see if it can help people with a certain type of leukemia live longer.
Who is the study for?
Adults over 18 with acute myeloid leukemia (AML) in second remission, not eligible for stem cell transplant, and who have good liver function. Women must be non-pregnant, postmenopausal or surgically sterile; sexually active participants must use contraception. Excludes those with severe allergies to certain immune stimulants, other cancers within 5 years, autoimmune diseases requiring treatment in the past 2 years, CNS leukemia or recent investigational drug use.Check my eligibility
What is being tested?
The trial is testing Galinpepimut-S (GPS), a new therapy against the best available treatments chosen by investigators for AML patients in their second complete remission. The main goal is to compare overall survival rates between GPS and existing therapies.See study design
What are the potential side effects?
Potential side effects of Galinpepimut-S may include allergic reactions due to its components like Montanide and immune stimulants GM-CSF or G-CSF. Other common cancer treatment side effects could occur such as fatigue, nausea, blood disorders but specific side effects of GPS are not detailed.
REGAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may not be able to do heavy physical work.
Select...
My cancer is in its second complete remission.
Select...
I have been diagnosed with AML.
Select...
I am 18 years or older and have given my consent.
Select...
I am not eligible for a stem cell transplant from a donor.
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My kidneys are not in end stage failure.
REGAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6, 9 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6, 9 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
LFS
LFS rate (%)
MRD
+1 moreREGAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Galinpepimut-S + Montanide + GM-CSFExperimental Treatment3 Interventions
A maximum of 15 total injections will be administered as follows:
First 6 galinpepimut-S injections: every 2 weeks (Weeks 0 - 10) followed by a 4-week period of no treatment. The first series of 6 injections of galinpepimut-S define the initial immunization induction phase.
Injections 7 to 12: every 4 weeks (between Weeks 14 and 34) followed by a 6-week period of no treatment. The second series of injections of galinpepimut-S define the early immune booster phase.
Injections 13 to 15: every 6 weeks (between Weeks 40 and 52). The third series of injections of galinpepimut-S define the late immune booster phase.
Note: Galinpepimut-S is admixed with Montanide adjuvant before administered as a subcutaneous injection. GM-CSF is administered one day before and on the same day as the galinpepimut-S + Montanide injection.
Group II: Best Available TherapyActive Control5 Interventions
Four options, as monotherapy or as combination of agents listed below, (per treating investigator's choice):
Observation (whereby palliative management with hydroxyurea is allowed), or
HMA (decitabine or azacitidine), and/or
Venetoclax, and/or
Low-dose ara-C
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GM-CSF
2014
Completed Phase 4
~1340
Find a Location
Who is running the clinical trial?
Sellas Life Sciences GroupLead Sponsor
8 Previous Clinical Trials
675 Total Patients Enrolled
Dragan Cicic SVP Clinical Development, MDStudy DirectorSellas Life Sciences Group
Nicholas J Sarlis, MD, PhDStudy DirectorSellas Life Sciences Group
1 Previous Clinical Trials
90 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received a transplant from another person.I received my last leukemia treatment at least 4 weeks ago.My liver is functioning well.My leukemia has spread to my brain or spinal cord.I have been treated for an autoimmune disease in the last 2 years.I agreed to join within 6 months after my cancer went into remission for the second time.My cancer has spread to my brain or its coverings.I am currently being treated for a severe infection.I am continuing treatment that helped me achieve a second or later remission.I don't have any health issues that could affect the study's results.I have an immune system disorder or am on long-term steroids.I am a woman who is either postmenopausal, surgically sterile, or not pregnant.I can care for myself but may not be able to do heavy physical work.I have been diagnosed with a type of leukemia called acute promyelocytic.I have another cancer that has worsened or needed treatment in the last 5 years.My cancer is in its second complete remission.I haven't had a stem cell transplant after achieving my second or later complete remission.I am scheduled for a stem cell transplant soon.I have been diagnosed with AML.I can visit the clinic for follow-ups and follow the study rules.I agree to use effective birth control.I have recovered from side effects of my previous AML treatment.I am currently on treatment for AML.I haven't taken any leukemia treatments, steroids, or immunosuppressives recently.I am 18 years or older and have given my consent.I have not received a live vaccine in the last 30 days.I am not eligible for a stem cell transplant from a donor.My kidneys are not in end stage failure.
Research Study Groups:
This trial has the following groups:- Group 1: Galinpepimut-S + Montanide + GM-CSF
- Group 2: Best Available Therapy
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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