Trial Outcomes & Findings for WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) (NCT NCT01266083)

NCT ID: NCT01266083

Last Updated: 2024-11-19

Results Overview

OS at 3 years, measured from first treatment with GPS to patient's survival status at 3 years or more

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2024-11-19

Participant Flow

Participant milestones

Measure	Galinpepimut-S + Montanide + GM-CSF 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.
Overall Study STARTED	22
Overall Study Eligible for Additional Monthly Vaccinations After Initial 6 Vaccinations (Q2W)	13
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)

Baseline characteristics by cohort

Measure	Galinpepimut-S + Montanide + GM-CSF n=22 Participants 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.
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Karnofsky performance status	93.8 scores on a scale STANDARD_DEVIATION 5.9 • n=5 Participants
HLA-A* 02:01 positive	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Of the 22 patients, 19 (86.4%) were evaluable for survival at 3 years,

OS at 3 years, measured from first treatment with GPS to patient's survival status at 3 years or more

Outcome measures

Measure

Galinpepimut-S + Montanide + GM-CSF n=19 Participants 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. Galinpepimut-S: Galinpepimut-S admixed with the adjuvant Montanide following specified schedule GM-CSF: subcutaneous injection Montanide: adjuvant

Overall Survival

47 percentage of participants

SECONDARY outcome

Timeframe: 5 years and 8 months

Time to PFS measured from first administration of GPS to relapse or death from any cause

Outcome measures

Measure

Galinpepimut-S + Montanide + GM-CSF n=22 Participants 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. Galinpepimut-S: Galinpepimut-S admixed with the adjuvant Montanide following specified schedule GM-CSF: subcutaneous injection Montanide: adjuvant

Progression-free Survival

283 days Interval 71.0 to Upper limit of the 95% confidence interval was not reached at 5 years and 8 months due to end of study monitoring

Adverse Events

Galinpepimut-S + Montanide + GM-CSF

Serious events: 1 serious events

Other events: 21 other events

Deaths: 10 deaths

Serious adverse events

Measure	Galinpepimut-S + Montanide + GM-CSF n=22 participants at risk 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. Galinpepimut-S: Galinpepimut-S admixed with the adjuvant Montanide following specified schedule GM-CSF: subcutaneous injection Montanide: adjuvant
Cardiac disorders Non-cardiac chest pain	4.5% 1/22 • Number of events 1 • 5 years, 8 months
Musculoskeletal and connective tissue disorders Bone pain	4.5% 1/22 • Number of events 1 • 5 years, 8 months
Respiratory, thoracic and mediastinal disorders Dyspnea	4.5% 1/22 • Number of events 1 • 5 years, 8 months
Vascular disorders Flushing	4.5% 1/22 • Number of events 1 • 5 years, 8 months

Other adverse events

Measure	Galinpepimut-S + Montanide + GM-CSF n=22 participants at risk 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. Galinpepimut-S: Galinpepimut-S admixed with the adjuvant Montanide following specified schedule GM-CSF: subcutaneous injection Montanide: adjuvant
General disorders Injection Site Reaction	45.5% 10/22 • 5 years, 8 months
Skin and subcutaneous tissue disorders Skin Induration	31.8% 7/22 • 5 years, 8 months
General disorders Fatigue	31.8% 7/22 • 5 years, 8 months
Skin and subcutaneous tissue disorders Pruritus	27.3% 6/22 • 5 years, 8 months
Investigations Lymphocyte Count Decreased	27.3% 6/22 • 5 years, 8 months
Investigations Neutrophil Count Decreased	27.3% 6/22 • 5 years, 8 months
Investigations White Blood Cell Count Decreased	27.3% 6/22 • 5 years, 8 months
Investigations Platelet Count Decreased	18.2% 4/22 • 5 years, 8 months
General disorders Pain	13.6% 3/22 • 5 years, 8 months
Skin and subcutaneous tissue disorders Erythema Multiforme	13.6% 3/22 • 5 years, 8 months
Musculoskeletal and connective tissue disorders Pain in Extremity	13.6% 3/22 • 5 years, 8 months
Vascular disorders Flushing	13.6% 3/22 • 5 years, 8 months
Skin and subcutaneous tissue disorders Dry Skin	9.1% 2/22 • 5 years, 8 months
Skin and subcutaneous tissue disorders Rash Maculo-Papular	9.1% 2/22 • 5 years, 8 months
Musculoskeletal and connective tissue disorders Bone Pain	9.1% 2/22 • 5 years, 8 months
Musculoskeletal and connective tissue disorders Muscular Weakness	9.1% 2/22 • 5 years, 8 months
Infections and infestations Skin Infection	9.1% 2/22 • 5 years, 8 months
Infections and infestations Upper Respiratory Tract Infection	9.1% 2/22 • 5 years, 8 months
Infections and infestations Urinary Tract Infection	9.1% 2/22 • 5 years, 8 months
Nervous system disorders Headache	9.1% 2/22 • 5 years, 8 months

Additional Information

Dragan Cicic

Sellas Life Sciences

Phone: 646-200-5278

Email: info@sellaslife.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place