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

Leukemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466726
• Other study ID #: CML 0206
• Secondary ID: 2006-006189-40
• Status: Completed
• Phase: Phase 2
• Start date: March 2007
• Est. completion date: July 2014

Study information

• Verified date: August 2018
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00452933

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Philadelphia Chromosome

Intervention

Biological:
• bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine

• sargramostim

Locations

Country	Name	City	State
Italy	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	Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore	Rome
Italy	Universita Degli Studi "La Sapeinza"	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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At 6 and 9 months
Secondary	Number of Patients With Undetectable Transcript at Any Time After Immunization		Up to 6 months
Secondary	Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations	A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation	At 9 months

External Links

•   GIMEMA Foundation website