Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2

Conditions

• Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

To assess the safety and efficacy of galinpepimut-S (GPS) compared with investigator's choice of best available therapy (BAT) on overall survival (OS) in subjects with acute myeloid leukemia (AML) who are in second or later complete remission (CR2) or second or later complete remission with incomplete platelet recovery (CRp2).

Key Dates

Start date

Feb 8, 2021

Status verified

Sep 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2026

Study Design

Enrollment

127 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Galinpepimut-S + Montanide + GM-CSF
  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.
• Active Comparator: Best Available Therapy
  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

Primary Outcome Measure

OS [ Time Frame: 5 years ]

Locations (17)

Find similar trials in Birmingham, AL

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