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Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease
This study has been completed.
Sponsors and Collaborators: M.D. Anderson Cancer Center
BreakThrough Therapeutics
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00267085
  Purpose

The goal of this clinical research study is to learn if giving 1 of 2 vaccines (CML-VAX B2 or CML-VAX B3) together with imatinib mesylate can decrease or eliminate all evidence of disease in patients who have CML that is in remission after treatment with imatinib mesylate, but who still have small amounts of detectable disease.


Condition Intervention Phase
Chronic Myeloid Leukemia
Minimal Residual Disease
Biological: Synthetic Tumor-Specific Breakpoint Peptide Vaccine
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia (CML) and Minimal Residual Disease

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To evaluate the anti-leukemic effects of vaccination with CML breakpoint peptides as measured by a one-log decrease in circulating BCR-ABL transcripts using reverse transcription polymerase chain reaction (RT-PCR). [ Time Frame: September 2007 ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: December 2005
Study Completion Date: July 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
CML-VAX B2 or CML-VAX B3
Biological: Synthetic Tumor-Specific Breakpoint Peptide Vaccine
CML-VAX B2 or CML-VAX B3

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with Ph chromosome positive or BCR-ABL-positive CML (as determined by cytogenetics, FISH, or RT-PCR).
  2. Patients must have reached their 18th birthday.
  3. Patients must have received imatinib therapy for at least 12 months and must not have had changes in their dose of imatinib in the last 6 months. Patients must not have had a continuous interruption of imatinib therapy of greater than 14 days or for a total of 6 weeks in the 6 months prior to enrollment.
  4. Patients must be in complete cytogenetic remission confirmed by two marrows, the second being at least one month after the first.
  5. Patients must have detectable BCR-ABL transcript levels that are not more than 0.5-log lower than the lowest value obtained in the last 6 months, with at least two values obtained during this period.
  6. Karnofsky performance status should be > 70.
  7. Adequate organ function defined as: bilirubin <2x upper limit of normal (ULN), creatinine <1.5x ULN, and ALT and AST <2.5x ULN.
  8. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  9. Women of childbearing potential (i.e., not post-menopausal 24 months or not surgically sterile) must agree to use effective methods of contraception.

Exclusion Criteria:

  1. Patients with a history of accelerated or blast crisis. Accelerated phase is defined as 15 to 30% blasts or >30% blasts plus promyelocytes in the peripheral blood or marrow, >20% basophils, or platelets <100 x 10^9/L, unrelated to therapy. Cytogenetic abnormalities in addition to the Ph chromosome are not considered a defining feature of accelerated phase.
  2. Patients with autoimmune disorders or known immune deficiency.
  3. Patients receiving immunosuppressive therapy, corticosteroids, chemotherapy, or therapy for CML other than imatinib.
  4. Patients receiving any other investigational agents.
  5. Patients who are pregnant or breast-feeding.
  6. Patients with clinically significant heart disease (New York Heart Association Class III or IV) or other serious intercurrent illnesses, active uncontrolled infections requiring antibiotics or active bleeding.
  7. Patients who have undergone major surgery within 28 days before registration, or who have not fully recovered from any other prior major surgery.
  8. Patients who have undergone stem cell transplantation.
  9. Patients who have received radiation therapy within 4 weeks of enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267085

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
BreakThrough Therapeutics
Investigators
Principal Investigator: Jorge E. Cortes, M.D. U.T.M.D. Anderson Cancer Center
  More Information

M.D. Anderson's Website  This link exits the ClinicalTrials.gov site

Responsible Party: The University of Texas M. D. Anderson Cancer Center ( Jorge Cortes M.D./Professor )
Study ID Numbers: 2005-0392
Study First Received: December 19, 2005
Last Updated: July 31, 2008
ClinicalTrials.gov Identifier: NCT00267085  
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Chronic Myeloid Leukemia
Minimal Residual Disease
Peptide Vaccine

Study placed in the following topic categories:
Neoplasm, Residual
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009