A Phase 2 interventional study of Galinpepimut-S and GM-CSF in Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Sellas Life Sciences Group. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Sellas Life Sciences Group · Phase 2, Interventional, and Treatment
This trial will assess the safety and efficacy of vaccination with galinpepimut-S (GPS), a WT1 peptide vaccine, in patients who are in complete remission from leukemia.
Participants will receive vaccinations with GPS every 2 weeks for 10 weeks (a total of 6 vaccinations). In the absence of disease recurrence at Week 12 and if clinically stable after the first 6 vaccinations, participants may continue to receive up to six more vaccinations every month.
This clinical study is conducted in patients in complete remission from acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). The primary objective is to assess the effect of vaccination with galinpepimut-S (GPS) on patient survival and the safety profile.
Galinpepimut-S (GPS) consists of four WT1-derived peptides which have been chosen to strengthen antigenicity, but also broaden immunogenicity over a wide range of HLA subtypes, being able to stimulate both CD8+ (MHC Class I)- and CD4+ (MHC Class II)-dependent responses. Galinpepimut-S is administered with the adjuvant Montanide and sargramostim (GM-CSF).
Participants will receive vaccinations with GPS every 2 weeks for 10 weeks (a total of 6 vaccinations). In the absence of disease recurrence at Week 12 evaluation and if clinically stable after the first 6 vaccinations, participants may continue to receive up to six more vaccinations every month. Following the last vaccination, participants will be followed regularly (every 1 to 3 months) in an outpatinet setting for up to 3 years from the first treatment date.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's enrollment of 22 is below the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Sellas Life Sciences Group is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(ANC) ≥ 1000/μL
Biochemical parameters:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Galinpepimut-S (GPS) and Montanide (in a 1 mL emulsion) are administered subcutaneously (s.c.) Q2W on weeks 0, 2, 4, 6, 8, and 10. GM-CSF (70 μg) are administered s.c. one to two days before and on the day of GPS/Montanide administration. Participants with no recurrence after Week 12 and who are clinically stable may be eligible to receive up to 6 additional monthly vaccinations.
Biological: Galinpepimut-S · Biological: GM-CSF · Other: Montanide
Galinpepimut-S admixed with the adjuvant Montanide following specified schedule
Also known as: GPS, SLS-001
subcutaneous injection
Also known as: sargramostim
adjuvant
Overall Survival
OS at 3 years, measured from first treatment with GPS to patient's survival status at 3 years or more
Time frame: 3 years
Progression-free Survival
Time to PFS measured from first administration of GPS to relapse or death from any cause
Time frame: 5 years and 8 months
| Milestone | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Started | 22 |
| Eligible for additional monthly vaccinations after initial 6 vaccinations (q2w) | 13 |
| Completed | 22 |
| Not completed | 0 |
OS at 3 years, measured from first treatment with GPS to patient's survival status at 3 years or more
| percentage of participants | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Overall Survival | 47 |
Time to PFS measured from first administration of GPS to relapse or death from any cause
| days | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Progression-free Survival | 283 (71 to NA) |
Collected over 5 years, 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Galinpepimut-S + Montanide + GM-CSF | 10/22 (45.5%) | 1/22 (4.5%) | 21/22 (95.5%) |
| Event | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Non-cardiac chest painCardiac disorders | 1/22 |
| Bone painMusculoskeletal and connective tissue disorders | 1/22 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/22 |
| FlushingVascular disorders | 1/22 |
| Event | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Injection Site ReactionGeneral disorders | 10/22 |
| Skin IndurationSkin and subcutaneous tissue disorders | 7/22 |
| FatigueGeneral disorders | 7/22 |
| PruritusSkin and subcutaneous tissue disorders | 6/22 |
| Lymphocyte Count DecreasedInvestigations | 6/22 |
| Neutrophil Count DecreasedInvestigations | 6/22 |
| White Blood Cell Count DecreasedInvestigations | 6/22 |
| Platelet Count DecreasedInvestigations | 4/22 |
| PainGeneral disorders | 3/22 |
| Erythema MultiformeSkin and subcutaneous tissue disorders | 3/22 |
| Age, Continuous(years) | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Median | 64 (25 to 76) |
| Sex: Female, Male(Participants) | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Female | 15 |
| Male | 7 |
| Karnofsky performance status(scores on a scale) | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Mean | 93.8 ± 5.9 |
| HLA-A* 02:01 positive(Participants) | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Count of participants | 9 |
Plan to share: No
Ran from Jan 2011 to primary completion in Sep 2016, 68 months.
Results were first posted in Nov 2024, 8 years 1 month after primary completion.
Of 57 industry-sponsored phase 2 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 55. This study's 68 months is above that.
Counting every sponsor, half of 442 studies reached it within 60 months; a quarter within 38 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Galinpepimut-s · Granulocyte-Macrophage Colony-Stimulating Factor
Sellas Life Sciences Group