Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia (NCT NCT00466726)

NCT ID: NCT00466726

Last Updated: 2018-08-28

Results Overview

Response rate evaluated after immunization and reinforcement boosts (evaluation after 6 months, ) and persisting at the 9th month (after 10th vaccination)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 57 participants
• Primary outcome timeframe: At 6 and 9 months
• Results posted on: 2018-08-28

Participant Flow

Participant milestones

Measure	Chronic Myeloid Leukemia (CML) Patients Study population
Overall Study STARTED	57
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Chronic Myeloid Leukemia (CML) Patients Study population
Overall Study Not evaluable for response	14

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Chronic Myeloid Leukemia (CML) Patients n=43 Participants Study population
Age, Continuous	56.5 years n=43 Participants
Sex: Female, Male Female	16 Participants n=43 Participants
Sex: Female, Male Male	27 Participants n=43 Participants
Region of Enrollment Italy	43 participants n=43 Participants

PRIMARY outcome

Timeframe: At 6 and 9 months

Response rate evaluated after immunization and reinforcement boosts (evaluation after 6 months, ) and persisting at the 9th month (after 10th vaccination)

Outcome measures

Measure	Chronic Myeloid Leukemia (CML) Patients n=43 Participants Study population
Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level 50% reduction at 6 months	22 participants
Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level 50% reduction at 9 months	14 participants

SECONDARY outcome

Timeframe: Up to 6 months

Outcome measures

Measure	Chronic Myeloid Leukemia (CML) Patients n=43 Participants Study population
Number of Patients With Undetectable Transcript at Any Time After Immunization	14 participants

SECONDARY outcome

Timeframe: At 9 months

A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation

Outcome measures

Measure	Chronic Myeloid Leukemia (CML) Patients n=43 Participants Study population
Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations	29 participants

Adverse Events

Chronic Myeloid Leukemia (CML) Patients

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Chronic Myeloid Leukemia (CML) Patients n=43 participants at risk Study population
General disorders Mild fever	9.3% 4/43 • Number of events 4

Additional Information

Alfonso Piciocchi

GIMEMA

Phone: +39 06 70390513

Email: a.piciocchi@gimema.it

Results disclosure agreements

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