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AzTrials

LeukemiaPhase 2CML0206NCT00466726

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

A Phase 2 study testing bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine and sargramostim in people with Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 17 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Leukemia
What is being tested?
bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine and sargramostim
Type of treatment
Vaccines
How many people
57 participants
Where
17 sitesItaly
Study dates
Mar 2007to Jul 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Italy17 sites

  • Universita Degli Studi di Bari

    Bari, 70124

  • Ospedali Riuniti di Bergamo

    Bergamo, 24100

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

    Bologna

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

    Brescia

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

    Catania

  • Ospedale Regionale A. Pugliese

    Catanzaro, 88100

  • Federico II University Medical School

    Naples, 80131

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

    Novara

  • Azienda Ospedale S. Luigi at University of Torino

    Orbassano, 10043

  • spedali Riuniti "Villa Sofia-Cervello"

    Palermo

  • Ospedale Sant' Eugenio

    Rome, 00144

  • Universita Degli Studi "La Sapeinza"

    Rome, 00161

  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

    Rome, 00168

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

    Rossano

  • Ematologia - Dipartimento di Medicina Clinica e Sperimentale

    Sassari

  • Nouvo Policlinico "LE SCOTTE'

    Siena, 53100

  • Policlinico Universitario Udine

    Udine, 33100

Other trials in Italy

About this study

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

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.

Read the 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
Being tested
bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine, sargramostim
Keywords
chronic myelogenous leukemia, BCR-ABL1 positive, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia
Medical subject headings
Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Accelerated Phase, Blast Crisis, Leukemia, Myeloid, Chronic-Phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccineBiological

  • sargramostimBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: At 6 and 9 months

Secondary outcomes (2)

  1. Number of Patients With Undetectable Transcript at Any Time After Immunization

    Measured: Up to 6 months

  2. Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations

    A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation

    Measured: At 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00466726
Sponsor's protocol ID
CML 0206
Other IDs
2006-006189-40
Acronym
CML0206
Status last verified
Aug 2018
First submitted
25 Apr 2007
Last updated
28 Aug 2018
Data monitoring committee
No

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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine and sargramostim in people with Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 17 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00466726, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.

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