Safety Assessment of a Multipeptide-gene Vaccine in CML

NCT00455221 | Completed Phase 1 DMC

• 1 other identifier: 418-A-2209
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate the safety of a peptide-gene vaccine against CML in patients under Imatinib treatment. We will also perform some laboratory tests suggesting biological response.

Conditions

Leukemia, Myeloid, Chronic

Keywords

CML; Imatinib; vaccine; peptide; gene; MRD; DNA

Outcome Measures

Primary Outcomes (1)

• To assess safety of bcr-abl peptide vaccination in Ph+ or MRD CML patients

  At enroll in study and 3 months after intervention

Secondary Outcomes (1)

• To measure the development of a molecular response to vaccination as measured by 1 log decrease in qRT-PCR BCR-ABL levels for at least 3 months; To measure the development of immune response following vaccination

  At enroll in study and 3 months after intervention

Study Arms (1)

Peptide Vaccine

EXPERIMENTAL

Biological: Bcr-abl multipeptide vaccine; Genetic: Cytokine gene adjuvant

Interventions

Bcr-abl multipeptide vaccine BIOLOGICAL

The first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the lower dose of IL-12 plasmid and higher dose of GM-CSF plasmid. If this is well tolerated, then the next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the higher dose of both IL-12 and GM-CSF plasmids. Once assigned to a dose, the patient will receive the same dose throughout their participation in this trial

Peptide Vaccine

Cytokine gene adjuvant GENETIC

Cytokine gene adjuvant

Peptide Vaccine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Philadelphia chromosome positive CML who are:
• of subtype b3a2
• In first complete hematologic response;
• have received imatinib for \> 12 months of which the last 3 months were at a stable dose of at least 400 mg/day;
• have PCR detectable BCR-ABL transcript by qRT-PCR, and
• with persistent disease, as defined by \<1 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared with a standardized baseline.
• Greater than or equal to 18 years in age
• No known infection with human immunodeficiency virus
• Physician and patient willingness to maintain the baseline dose of imatinib throughout the study period
• Written informed consent obtained from the patient

You may not qualify if:

• Female patients who are pregnant or breast feeding or adults of childbearing age who are not using adequate birth control.
• Current use of systemic immunosuppressive medications
• ALT or AST \>3X Upper limit Normal
• Prior allogeneic stem cell transplantation
• Other experimental therapy within the past two months
• Prior participation in vaccine studies within the past six months
• Oxygen saturation of less than 95% at room air
• History of recent acute myocardial infarction, unstable angina, or pulmonary decompensation requiring hospitalization within the past 3 months.
• Concurrent and or uncontrolled psychiatric or medical condition which may interfere with the study completion.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, 14114, Iran

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Seyed Hamidollah Ghaffari, PhD

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2007
• First Posted: April 3, 2007
• Study Start: February 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: November 1, 2011
• Last Updated: June 4, 2012

Record last verified: 2012-05

Locations

IR (1)