Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia (CML0206)

August 27, 2018 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Università degli Studi di Bari
      • Bergamo, Italy, 24100
        • Ospedali Riuniti di Bergamo
      • Bologna, Italy
        • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
      • Brescia, Italy
        • USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia
      • Catania, Italy
        • Università di Catania - Cattedra di Ematologia - Ospedale 'Ferrarotto'
      • Catanzaro, Italy, 88100
        • Ospedale Regionale A. Pugliese
      • Naples, Italy, 80131
        • Federico II University Medical School
      • Novara, Italy
        • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
      • Orbassano, Italy, 10043
        • Azienda Ospedale S. Luigi at University of Torino
      • Palermo, Italy
        • spedali Riuniti "Villa Sofia-Cervello"
      • Rome, Italy, 00144
        • Ospedale Sant' Eugenio
      • Rome, Italy, 00161
        • Universita Degli Studi "La Sapeinza"
      • Rome, Italy, 00168
        • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
      • Rossano, Italy
        • Unità Operativa di Oncologia - Presidio Ospedaliero N. Giannetasio - Azienda ASL 3
      • Sassari, Italy
        • Ematologia - Dipartimento di Medicina Clinica e Sperimentale
      • Siena, Italy, 53100
        • Nouvo Policlinico "LE SCOTTE'
      • Udine, Italy, 33100
        • Policlinico Universitario Udine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level
Time Frame: 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)
At 6 and 9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Study Chair: Monica Bocchia, MD, Nouvo Policlinico "LE SCOTTE'

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 25, 2007

First Submitted That Met QC Criteria

April 25, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CML 0206
  • 2006-006189-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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