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

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level	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)

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Undetectable Transcript at Any Time After Immunization	Up to 6 months
Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations	At 9 months	A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation

Locations (17): Ospedali Riuniti di Bergamo
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Bergamo, Italy
Universita Degli Studi di Bari
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Bari, Italy
USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia
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Brescia, Italy
Università di Catania - Cattedra di Ematologia - Ospedale 'Ferrarotto'
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Catania, Italy
Ospedale Regionale A. Pugliese
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Catanzaro, Italy
Federico II University Medical School
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Naples, Italy
Azienda Ospedale S. Luigi at University of Torino
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Orbassano, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
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Novara, Italy
spedali Riuniti "Villa Sofia-Cervello"
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Palermo, Italy
Ospedale Sant' Eugenio
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Rome, Italy
Universita Degli Studi "La Sapeinza"
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Rome, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
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Rome, Italy
Unità Operativa di Oncologia - Presidio Ospedaliero N. Giannetasio - Azienda ASL 3
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Rossano, Italy
Nouvo Policlinico "LE SCOTTE'
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Siena, Italy
Ematologia - Dipartimento di Medicina Clinica e Sperimentale
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Sassari, Italy
Policlinico Universitario Udine
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Udine, Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
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Bologna, Italy