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Trial record 14 of 201 for:    "Leukemia" | "Sargramostim"

Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia (CML0206)

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ClinicalTrials.gov Identifier: NCT00466726
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Biological: bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine
Biological: sargramostim
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chronic Myeloid Leukemia (CML) Patients
Hide Arm/Group Description Study population
Period Title: Overall Study
Started 57
Completed 43
Not Completed 14
Reason Not Completed
Not evaluable for response             14
Arm/Group Title Chronic Myeloid Leukemia (CML) Patients
Hide Arm/Group Description Study population
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 43 participants
56.5
(29 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
16
  37.2%
Male
27
  62.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 43 participants
43
1.Primary Outcome
Title Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level
Hide Description Response rate evaluated after immunization and reinforcement boosts (evaluation after 6 months, ) and persisting at the 9th month (after 10th vaccination)
Time Frame At 6 and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chronic Myeloid Leukemia (CML) Patients
Hide Arm/Group Description:
Study population
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
50% reduction at 6 months 22
50% reduction at 9 months 14
2.Secondary Outcome
Title Number of Patients With Undetectable Transcript at Any Time After Immunization
Hide Description [Not Specified]
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chronic Myeloid Leukemia (CML) Patients
Hide Arm/Group Description:
Study population
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
14
3.Secondary Outcome
Title Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations
Hide Description A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation
Time Frame At 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chronic Myeloid Leukemia (CML) Patients
Hide Arm/Group Description:
Study population
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
29
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chronic Myeloid Leukemia (CML) Patients
Hide Arm/Group Description Study population
All-Cause Mortality
Chronic Myeloid Leukemia (CML) Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chronic Myeloid Leukemia (CML) Patients
Affected / at Risk (%) # Events
Total   0/43 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chronic Myeloid Leukemia (CML) Patients
Affected / at Risk (%) # Events
Total   4/43 (9.30%)    
General disorders   
Mild fever *  4/43 (9.30%)  4
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alfonso Piciocchi
Organization: GIMEMA
Phone: +39 06 70390513
EMail: a.piciocchi@gimema.it
Publications of Results:
BCR-ABL Derived Peptide Vaccine in Chronic Myeloid Leukemia Patients with Molecular Minimal Residual Disease During Imatinib: Interim Analysis of a Phase 2 Multicenter GIMEMA CML Working Party Trial.
Layout table for additonal information
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00466726     History of Changes
Obsolete Identifiers: NCT00452933
Other Study ID Numbers: CML 0206
2006-006189-40 ( EudraCT Number )
First Submitted: April 25, 2007
First Posted: April 27, 2007
Results First Submitted: November 21, 2017
Results First Posted: August 28, 2018
Last Update Posted: August 28, 2018