Status:
COMPLETED
Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Leukemia
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 fo...
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 Phil...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00466726
Start Date
March 1 2007
End Date
July 1 2014
Last Update
August 28 2018
Active Locations (17)
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1
Universita Degli Studi di Bari
Bari, Italy, 70124
2
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100
3
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, Italy
4
USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia
Brescia, Italy