Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Other GIMEMA-CML0206 EUDRACT-2006-006189-40, EU-20724, CML0206, NCT00466726

Objectives

Primary

1. 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

1. Determine the reduction of molecular residual disease at 3 months in patients treated with this vaccine.
2. Determine the reduction of molecular residual disease at 12 months in patients treated with maintenance boosts of this vaccine.
3. Determine the rate of complete molecular response at any time after vaccination.
4. Determine in vivo and in vitro peptide-specific immune response induced by the vaccine.

Entry 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

Prior/Concurrent Therapy:

• No concurrent immunosuppression or systemic immunosuppressive medication
• No concurrent dose escalation of imatinib mesylate
• No other concurrent investigational products

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

Expected Enrollment

A total of 69 patients will be accrued for this study.

Outcomes

Response rate at 6 and 9 months

Reduction of molecular residual disease at 3 months
Reduction of molecular residual disease at 12 months
Rate of complete molecular response
In vivo and in vitro peptide-specific immune response induced by vaccination

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.

Trial Contact Information

Trial Lead Organizations

Gruppo Italiano Malattie Ematologiche dell’Adulto

Monica Bocchia, MD, Protocol chair		Ph: 39-057-758-6798

Italy
	Bari
	Universita Degli Studi di Bari
		Vincenzo Liso, MD	Ph:  39-080-547-8711
	Bergamo
	Ospedali Riuniti di Bergamo
		Alessandro Rambaldi, MD	Ph:  39-35-269491
	Catanzaro
	Ospedale Regionale A. Pugliese
		Antonia Peta, MD	Ph:  39-961-883-346
	Naples
	Federico II University Medical School
		Bruno Rotoli, MD	Ph:  39-081-746-2068
			Email: rotoli@unina.it
	Orbassano
	Azienda Ospedale S. Luigi at University of Torino
		Giuseppe Saglio, MD	Ph:  39-011-902-6610
	Rome
	Ospedale Sant' Eugenio
		Sergio Amadori, MD	Ph:  39-06-591-4745
			Email: mc7673@mclink.it
	Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
		Giuseppe Leone, MD	Ph:  39-6-3015-4180
			Email: gleone@rm.unicatt.it
	Universita Degli Studi "La Sapeinza"
		Roberto Foa, MD	Ph:  39-6-8579-5753
	Siena
	Nouvo Policlinico "LE SCOTTE'
		Monica Bocchia, MD	Ph:  39-057-758-6798
	Udine
	Policlinico Universitario Udine
		Renato Fanin, MD	Ph:  39-0432-239-300

Registry Information
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
Trial Start Date		2007-03-01
Registered in ClinicalTrials.gov		NCT00466726
Date Submitted to PDQ		2007-03-23
Information Last Verified		2007-04-25