This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center Identifier:
First received: August 10, 2006
Last updated: July 12, 2017
Last verified: July 2017

RATIONALE: Tyrosine kinase inhibitors may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer cells. GM-CSF may help cells that are involved in the body's immune response work better. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells.

PURPOSE: This randomized phase II trial is studying tyrosine kinase inhibitors, interferon alfa, and GM-CSF to see how well they work compared to tyrosine kinase inhibitors and vaccine therapy in treating patients with chronic phase chronic myelogenous leukemia.

Condition Intervention Phase
Leukemia Biological: GM-K562 cell vaccine Biological: recombinant interferon alfa Biological: sargramostim Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Interferon + GM-CSF Versus K562/GM-CSF Vaccination in CML Patients Achieving a Complete Cytogenetic Response to Frontline Tyrosine Kinase Inhibitor Therapy

Resource links provided by NLM:

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Progression-free survival at 1 year
  • Rate of molecular complete remission

Secondary Outcome Measures:
  • Time to Philadelphia chromosome (Ph) negativity as measured by polymerase chain reaction
  • Disease-free survival
  • Percent molecular complete remission
  • Toxicity
  • Time to progression

Enrollment: 36
Study Start Date: September 2006
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients will receive injections of interferon alfa and GM-CSF once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Biological: recombinant interferon alfa
Given by injection
Biological: sargramostim
Given by injection
Experimental: Arm II
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + GM-CSF (Arm A).
Biological: GM-K562 cell vaccine
Given by injection

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of chronic myelogenous leukemia (CML) in chronic phase based on cytogenetic detection of the Philadelphia chromosome and/or detection of the BCR-ABL rearrangement by any of the following molecular methods:

    • Recombinant DNA analysis of the BCR-ABL fusion gene
    • Fluorescence in situ hybridization (FISH)
    • Polymerase chain reaction detection of the BCR-ABL hybrid mRNA
  • Documentation of complete cytogenetic response by conventional cytogenetic or FISH analysis while on a stable dose of tyrosine kinase inhibitor
  • No other phase of CML


  • ECG performance status 0-2
  • Life expectancy > 24 months
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 2.0 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • No other malignancy within the past 5 years except in situ cervical carcinoma or adequately treated nonmelanoma skin cancer
  • No other disease requiring long-term corticosteroids or immunosuppressants


  • At least 28 days since prior investigational agents
  • No prior bone marrow transplant or other transplant
  • No concurrent immunosuppressants (e.g., steroids, cyclosporine, azathioprine, mycophenolate mofetil, sirolimus, or tacrolimus)
  • No concurrent hydroxyurea, busulfan, or cytoreductive agents (other than frontline TKI)
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00363649

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: B. Douglas Smith, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center Identifier: NCT00363649     History of Changes
Other Study ID Numbers: J05121 CDR0000492005
P30CA006973 ( U.S. NIH Grant/Contract )
Study First Received: August 10, 2006
Last Updated: July 12, 2017

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Philadelphia chromosome positive chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents processed this record on September 19, 2017