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

NCT00363649 | Completed Phase 2 Results

• 2 other identifiers: J05121P30CA006973
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

Philadelphia chromosome positive chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival

  Number of patients alive and without disease progression or relapse

  1 year after treatment has been stopped

• Complete Remission Rate

  Percentage of patients who achieved molecular remission as defined by polymerase chain reaction negativity.

  Up to 18 months

Secondary Outcomes (3)

• Time to Complete Molecular Remission

  Up to 27 months

• Disease-free Survival

  Up to 8 years

• Early Discontinuation

  1 year

Study Arms (2)

Arm A

EXPERIMENTAL

Patients will receive injections of interferon alfa and sargramostim 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: Interferon alfa; Biological: Sargramostim

Arm B

EXPERIMENTAL

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 + sargramostim (Arm A).

Biological: GM-K562 cell vaccine

Interventions

GM-K562 cell vaccine BIOLOGICAL

Given by injection

Arm B

Interferon alfa BIOLOGICAL

Given by injection

Arm A

Sargramostim BIOLOGICAL

Given by injection

Also known as: GM-CSF

Arm A

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * 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 PRIOR CONCURRENT THERAPY: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Interventions

Interferon-alpha; sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors

Results Point of Contact

• Title: Doug Smith, MD
• Organization: Johns Hopkins University

smithdo@jhmi.edu

4102872935

Study Officials

• B. Douglas Smith, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Participants were randomly assigned to Arm A or Arm B and received up to twelve months of protocol therapy. If at any point a participant progressed, relapsed, or had unacceptable toxicity, they could cross over to the other arm. Participants could only cross over once.

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: September 1, 2006
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 13, 2018
• Results First Posted: November 13, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)