Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04229979 | Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 | PHASE3 | ACTIVE NOT_RECRUITING | 127 | — | — | Feb 8, 2021 | Dec 1, 2026 | Oct 1, 2025 | 73 | United States, France +8 |
| NCT01266083 | WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) | PHASE2 | COMPLETED | 22 | — | — | Jan 14, 2011 | Sep 30, 2016 | Nov 19, 2024 | 1 | United States |
Interval between randomization and death from any cause
OS at 3 years, measured from first treatment with GPS to patient's survival status at 3 years or more
| Arm | Type | Description |
|---|---|---|
| Galinpepimut-S + Montanide + GM-CSF | EXPERIMENTAL | Galinpepimut-S injections will be administered as follows, until disease relapse: 1. 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. 2. Injections 7 to 12: every 4 weeks (Weeks 14 - 34) followed by a 6-week period of no treatment. The second series of injections of galinpepimut-S define the early immune booster phase. 3. Injections 13 to 15: every 6 weeks (Weeks 40 - 52). The third series of injections of galinpepimut-S define the late immune booster phase. 4. Injections 16-20: every 2 months (in Year 2). 5. Injection 21 and thereafter: every 3 months (in Year 3). Y2 and Y3 define the maintenance phase. Note: Galinpepimut-S is admixed with Montanide adjuvant before administered as a subcutaneous injection. GM-CSF is administered two days before and on the same day as the galinpepimut-S + Montanide injection. |
| Best Available Therapy | ACTIVE_COMPARATOR | Four options, as monotherapy or as combination of agents listed below, (per treating investigator's choice): 1. Observation (whereby palliative management with hydroxyurea is allowed), or 2. HMA (decitabine or azacitidine), and/or 3. Venetoclax, and/or 4. Low-dose ara-C |
| Name | Type | Description |
|---|---|---|
| Galinpepimut-S | BIOLOGICAL | Galinpepimut-S admixed with the adjuvant Montanide following specified schedule |
| Azacitidine | DRUG | injection |
| Venetoclax | DRUG | tablet |
| Decitabine | DRUG | injection |
| Cytarabine | DRUG | injection |
| Observation | OTHER | palliative management |
| GM-CSF | BIOLOGICAL | subcutaneous injection |
| Montanide | OTHER | adjuvant |
Inclusion Criteria: 1. Willing and able to understand and provide signed informed consent for the study that fulfills Institution Review Board (IRB) guidelines. 2. Male or female patients ≥18 years of age on the day of signing informed consent. 3. Must have a diagnosis of AML according to the WHO c...