We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00363649
Recruitment Status : Active, not recruiting
First Posted : August 15, 2006
Last Update Posted : July 17, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Leukemia Biological: GM-K562 cell vaccine Biological: recombinant interferon alfa Biological: sargramostim Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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
Study Start Date : September 2006
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Interferon
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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): 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

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00363649     History of Changes
Other Study ID Numbers: J05121 CDR0000492005
P30CA006973 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 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