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

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ClinicalTrials.gov Identifier: NCT00466726
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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.


Condition or disease Intervention/treatment Phase
Leukemia Biological: bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine Biological: sargramostim Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2007
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Number of Patients With Undetectable Transcript at Any Time After Immunization [ Time Frame: Up to 6 months ]
  2. 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



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466726


Locations
Show Show 17 study locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Study Chair: Monica Bocchia, MD Nouvo Policlinico "LE SCOTTE'
Additional Information:
Publications of Results:
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.

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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00466726    
Obsolete Identifiers: NCT00452933
Other Study ID Numbers: CML 0206
2006-006189-40 ( EudraCT Number )
First Posted: April 27, 2007    Key Record Dates
Results First Posted: August 28, 2018
Last Update Posted: August 28, 2018
Last Verified: August 2018
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
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
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Sargramostim
Immunologic Factors
Physiological Effects of Drugs