Back to resultsVaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia (CML0206)
Primary Purpose
Leukemia
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine
sargramostim
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring chronic myelogenous leukemia, BCR-ABL1 positive, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of chronic myelogenous leukemia (CML) meeting the following criteria:
- Philadelphia chromosome positive disease
- b3a2 breakpoint mutation
Prior treatment with conventional imatinib mesylate for ≥ 18 months required
Complete cytogenetic response documented on ≥ 2 different examinations
- Persistence of molecularly detectable residual disease (any level of bcr-abl transcript)
- Patients continue to receive imatinib mesylate at the same dose (conventional treatment) during study treatment
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No severe active infection or other serious medical illness that would preclude study completion
- No known immunodeficiency
- No autoimmune disorders
PRIOR CONCURRENT THERAPY:
- No concurrent immunosuppression or systemic immunosuppressive medication
- No concurrent dose escalation of imatinib mesylate
- No other concurrent investigational products
Sites / Locations
- Universita Degli Studi di Bari
- Ospedali Riuniti di Bergamo
- Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
- USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia
- Università di Catania - Cattedra di Ematologia - Ospedale 'Ferrarotto'
- Ospedale Regionale A. Pugliese
- Federico II University Medical School
- S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
- Azienda Ospedale S. Luigi at University of Torino
- spedali Riuniti "Villa Sofia-Cervello"
- Ospedale Sant' Eugenio
- Universita Degli Studi "La Sapeinza"
- Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
- Unità Operativa di Oncologia - Presidio Ospedaliero N. Giannetasio - Azienda ASL 3
- Ematologia - Dipartimento di Medicina Clinica e Sperimentale
- Nouvo Policlinico "LE SCOTTE'
- Policlinico Universitario Udine
Outcomes
Primary Outcome Measures
Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level
Response rate evaluated after immunization and reinforcement boosts (evaluation after 6 months, ) and persisting at the 9th month (after 10th vaccination)
Secondary Outcome Measures
Number of Patients With Undetectable Transcript at Any Time After Immunization
Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations
A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation
Full Information
NCT ID
NCT00466726
First Posted
April 25, 2007
Last Updated
August 27, 2018
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
1. Study Identification
Unique Protocol Identification Number
NCT00466726
Brief Title
Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia
Acronym
CML0206
Official Title
Phase II Multicenter Study of P210-B3A2 Derived Peptide Vaccine in Chronic Myeloid Leukemia Patients in Complete Cytogenetic Response With Persistent Molecular Residual Disease During Imatinib Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with Philadelphia chromosome-positive chronic myelogenous leukemia.
Detailed Description
OBJECTIVES:
Primary
Determine the activity of bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine (CMLVAX100), in terms of peripheral blood bcr-abl/abl ratio reduction, in patients with Philadelphia chromosome-positive chronic myelogenous leukemia.
Secondary
Determine the reduction of molecular residual disease at 3 months in patients treated with this vaccine.
Determine the reduction of molecular residual disease at 12 months in patients treated with maintenance boosts of this vaccine.
Determine the rate of complete molecular response at any time after vaccination.
Determine in vivo and in vitro peptide-specific immune response induced by the vaccine.
OUTLINE: This is a prospective, nonrandomized, open-label, multicenter study.
Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1 and 2 and bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine (CMLVAX100) SC on day 2. Treatment repeats every 2 weeks for 6 courses. Patients then receive CMLVAX100 SC once monthly for 3 months and then once every 3 months for 6 months (for a total of 1 year). Patients may receive additional CMLVAX100 SC every 6 months for at least 3 years. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 69 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
chronic myelogenous leukemia, BCR-ABL1 positive, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine
Intervention Type
Biological
Intervention Name(s)
sargramostim
Primary Outcome Measure Information:
Title
Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level
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
Secondary Outcome Measure Information:
Title
Number of Patients With Undetectable Transcript at Any Time After Immunization
Time Frame
Up to 6 months
Title
Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations
Description
A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation
Time Frame
At 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of chronic myelogenous leukemia (CML) meeting the following criteria:
Philadelphia chromosome positive disease
b3a2 breakpoint mutation
Prior treatment with conventional imatinib mesylate for ≥ 18 months required
Complete cytogenetic response documented on ≥ 2 different examinations
Persistence of molecularly detectable residual disease (any level of bcr-abl transcript)
Patients continue to receive imatinib mesylate at the same dose (conventional treatment) during study treatment
PATIENT CHARACTERISTICS:
WHO performance status 0-1
Bilirubin ≤ 2 times upper limit of normal (ULN)
AST and ALT ≤ 2.5 times ULN
Creatinine ≤ 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No severe active infection or other serious medical illness that would preclude study completion
No known immunodeficiency
No autoimmune disorders
PRIOR CONCURRENT THERAPY:
No concurrent immunosuppression or systemic immunosuppressive medication
No concurrent dose escalation of imatinib mesylate
No other concurrent investigational products
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Bocchia, MD
Organizational Affiliation
Nouvo Policlinico "LE SCOTTE'
Official's Role
Study Chair
Facility Information:
Facility Name
Universita Degli Studi di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
City
Bologna
Country
Italy
Facility Name
USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia
City
Brescia
Country
Italy
Facility Name
Università di Catania - Cattedra di Ematologia - Ospedale 'Ferrarotto'
City
Catania
Country
Italy
Facility Name
Ospedale Regionale A. Pugliese
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Federico II University Medical School
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
City
Novara
Country
Italy
Facility Name
Azienda Ospedale S. Luigi at University of Torino
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
spedali Riuniti "Villa Sofia-Cervello"
City
Palermo
Country
Italy
Facility Name
Ospedale Sant' Eugenio
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Universita Degli Studi "La Sapeinza"
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Unità Operativa di Oncologia - Presidio Ospedaliero N. Giannetasio - Azienda ASL 3
City
Rossano
Country
Italy
Facility Name
Ematologia - Dipartimento di Medicina Clinica e Sperimentale
City
Sassari
Country
Italy
Facility Name
Nouvo Policlinico "LE SCOTTE'
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Policlinico Universitario Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
Links:
URL
http://www.gimema.it
Description
GIMEMA Foundation website
Learn more about this trial
Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia
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