Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease

NCT00267085 | Completed Phase 2 Results DMC

• 1 other identifier: 2005-0392
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if giving 1 of 2 CML (Chronic Myeloid Leukemia) 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.

Conditions

Chronic Myeloid Leukemia; Minimal Residual Disease

Keywords

Chronic Myeloid Leukemia; Minimal Residual Disease; Peptide Vaccine

Outcome Measures

Primary Outcomes (1)

• Response: One Log Decrease in BCR-ABL

  Molecular response defined as reduction by one log of the circulating peripheral blood for reverse transcription polymerase chain reaction (RT-PCR) transcripts of BCR-ABL (tumor-specific oncogenic fusion protein) after two consecutive measurements. RT-PCR performed at 3 month intervals. Response categorized as either 'No Decrease' or 'Decrease' if one log reduction in BCR-ABL detected.

  12 months

Study Arms (1)

CML Vaccine

EXPERIMENTAL

Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, then monthly for 10 months

Biological: Synthetic Tumor-Specific Breakpoint Peptide Vaccine

Interventions

Synthetic Tumor-Specific Breakpoint Peptide Vaccine BIOLOGICAL

CML vaccine, Imatinib mesylate, subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, then monthly for 10 months

Also known as: Imatinib mesylate

CML Vaccine

Eligibility Criteria

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

You may qualify if:

• Patients with Ph chromosome positive or BCR-ABL-positive CML (as determined by cytogenetics, FISH, or RT-PCR).
• Patients must have reached their 18th birthday.
• 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.
• Patients must be in complete cytogenetic remission confirmed by two marrows, the second being at least one month after the first.
• 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.
• Karnofsky performance status should be \> 70.
• Adequate organ function defined as: bilirubin \<2x upper limit of normal (ULN), creatinine \<1.5x ULN, and ALT and AST \<2.5x ULN.
• 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.
• Women of childbearing potential (i.e., not post-menopausal 24 months or not surgically sterile) must agree to use effective methods of contraception.

You may not qualify if:

• 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.
• Patients with autoimmune disorders or known immune deficiency.
• Patients receiving immunosuppressive therapy, corticosteroids, chemotherapy, or therapy for CML other than imatinib.
• Patients receiving any other investigational agents.
• Patients who are pregnant or breast-feeding.
• 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.
• Patients who have undergone major surgery within 28 days before registration, or who have not fully recovered from any other prior major surgery.
• Patients who have undergone stem cell transplantation.
• Patients who have received radiation therapy within 4 weeks of enrollment.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• BreakThrough Therapeutics: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson's Website

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasm, Residual

Interventions

Imatinib Mesylate

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; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Jorge Cortes M.D./Professor
• Organization: The University of Texas M. D. Anderson Cancer Center

eharriso@mdanderson.org

713/794-5783

Study Officials

• Jorge E. Cortes, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2005
• First Posted: December 20, 2005
• Study Start: December 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 7, 2012
• Results First Posted: February 25, 2011

Record last verified: 2012-08

Locations

US (1)