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

NCT ID: NCT00466726

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2014-07-31

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.

Conditions

Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica Bocchia, MD

Role: STUDY_CHAIR

Nouvo Policlinico "LE SCOTTE'

Locations

Universita Degli Studi di Bari

Bari, , Italy

Ospedali Riuniti di Bergamo

Bergamo, , Italy

Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi

Bologna, , Italy

USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia

Brescia, , Italy

Università di Catania - Cattedra di Ematologia - Ospedale 'Ferrarotto'

Catania, , Italy

Ospedale Regionale A. Pugliese

Catanzaro, , Italy

Federico II University Medical School

Naples, , Italy

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

Novara, , Italy

Azienda Ospedale S. Luigi at University of Torino

Orbassano, , Italy

spedali Riuniti "Villa Sofia-Cervello"

Palermo, , Italy

Ospedale Sant' Eugenio

Rome, , Italy

Universita Degli Studi "La Sapeinza"

Rome, , Italy

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, , Italy

Unità Operativa di Oncologia - Presidio Ospedaliero N. Giannetasio - Azienda ASL 3

Rossano, , Italy

Ematologia - Dipartimento di Medicina Clinica e Sperimentale

Sassari, , Italy

Nouvo Policlinico "LE SCOTTE'

Siena, , Italy

Policlinico Universitario Udine

Udine, , Italy

Countries

Italy

References

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.

Reference Type: RESULT

Related Links

http://www.gimema.it

GIMEMA Foundation website

Other Identifiers

2006-006189-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CML 0206

Identifier Type: -

Identifier Source: org_study_id

NCT00452933

Identifier Type: -

Identifier Source: nct_alias