Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia (NCT NCT00428077)

NCT ID: NCT00428077

Last Updated: 2011-09-02

Results Overview

One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: Every 3 months for the duration of the 1-year treatment period. .
• Results posted on: 2011-09-02

Participant Flow

Recruited from patient database in medical clinic.

Participant milestones

Measure	Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

Baseline characteristics by cohort

Measure	Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) n=4 Participants Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	59.75 years STANDARD_DEVIATION 3.59 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 3 months for the duration of the 1-year treatment period. .

Population: Per protocol.

One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.

Outcome measures

Measure	Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) n=4 Participants Patients with Philadelphia Chromosome (Ph+) or Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL),positive Chronic Myeloid Leukemia(CML), in cytogenetic remission, with minimal residual disease.
Number of Participants With One-log Decrease in Circulation Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) Transcripts That Persists for at Least Three Months During the 1-year Treatment Period.	4 Participants Interval 10.0 to 30.0

PRIMARY outcome

Timeframe: 12-24 Months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12-24 Months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12-24 Months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.

Outcome measures

Outcome data not reported

Adverse Events

Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) n=4 participants at risk Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
Gastrointestinal disorders Acute Viral Gastroenteritis	25.0% 1/4 • Number of events 1 • Adverse events were measured during entire 12 month period subjects received study drug.

Other adverse events

Measure	Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) n=4 participants at risk Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
Skin and subcutaneous tissue disorders Injection site induration	100.0% 4/4 • Number of events 4 • Adverse events were measured during entire 12 month period subjects received study drug.
General disorders Fatigue	75.0% 3/4 • Adverse events were measured during entire 12 month period subjects received study drug.
Eye disorders Cataracts	25.0% 1/4 • Number of events 1 • Adverse events were measured during entire 12 month period subjects received study drug.

Additional Information

Michael Deininger, MD, PhD

University of Utah Huntsman Cancer Institute

Phone: 801-585-3229

Email: michael.deininger@hci.utah.edu

Results disclosure agreements

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