NCT00466726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Mar 2007

Typical duration for phase_2 leukemia

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

August 28, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

7.3 years

First QC Date

April 25, 2007

Results QC Date

November 21, 2017

Last Update Submit

August 27, 2018

Conditions

Leukemia

Keywords

chronic myelogenous leukemia, BCR-ABL1 positiveaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Interventions

bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccineBIOLOGICAL
sargramostimBIOLOGICAL

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (17)

Universita Degli Studi di Bari

Bari, 70124, Italy

Location

Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

Location

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

Bologna, Italy

Location

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

Brescia, Italy

Location

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

Catania, Italy

Location

Ospedale Regionale A. Pugliese

Catanzaro, 88100, Italy

Location

Federico II University Medical School

Naples, 80131, Italy

Location

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

Novara, Italy

Location

Azienda Ospedale S. Luigi at University of Torino

Orbassano, 10043, Italy

Location

spedali Riuniti "Villa Sofia-Cervello"

Palermo, Italy

Location

Ospedale Sant' Eugenio

Rome, 00144, Italy

Location

Universita Degli Studi "La Sapeinza"

Rome, 00161, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

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

Rossano, Italy

Location

Ematologia - Dipartimento di Medicina Clinica e Sperimentale

Sassari, Italy

Location

Nouvo Policlinico "LE SCOTTE'

Siena, 53100, Italy

Location

Policlinico Universitario Udine

Udine, 33100, Italy

Location

Related 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.

    RESULT

Related Links

MeSH Terms

Conditions

LeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-Phase

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic Processes

Results Point of Contact

Title
Alfonso Piciocchi
Organization
GIMEMA
a.piciocchi@gimema.it
+39 06 70390513

Study Officials

  • Monica Bocchia, MD

    Nouvo Policlinico "LE SCOTTE'

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

March 1, 2007

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 28, 2018

Results First Posted

August 28, 2018

Record last verified: 2018-08

Locations

IT(17)