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Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate

Phase 1
18 Years
Open (Enrolling)

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Trial Information

Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate



- Determine the maximum tolerated dose of GM-K562 cell vaccine when administered with
imatinib mesylate in patients with persistent chronic phase chronic myelogenous
leukemia in first hematologic response.

- Determine the safety and toxic effects of GM-K562 cell vaccination in these patients.


- Determine the disease response by serial BCR-ABL quantitative polymerase chain reaction
measurements in patients treated with this regimen.

- Determine the development of tumor immunity in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of GM-K562.

Patients continue to receive oral imatinib mesylate at the same stable dose as before study
entry. Patients receive GM-K562 subcutaneously on days 1, 8, 15, 29, 43, 57, 85, 113, and
141 in the absence of disease progression or unacceptable toxicity.

Cohorts of 10 patients receive escalating doses of GM-K562 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 10 patients
experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically for 20 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of chronic myelogenous leukemia

- Chronic phase disease

- Philadelphia chromosome positive disease

- Disease in first complete hematologic response, defined by all of the following:

- Complete normalization of peripheral blood counts with WBC < 10,000/mm^3

- Platelet count < 450,000/mm^3

- No immature cells (e.g., myelocytes, metamyelocytes, or blasts) in the
peripheral blood

- Persistent molecular evidence of disease

- Detectable BCR-ABL transcript by quantitative polymerase chain reaction

- Less than 2 log reduction in peripheral blood or bone marrow BCR-ABL transcripts
levels compared to a standardized baseline

- Must have received imatinib mesylate for > 1 year of which the last 3 months were at
stable dose ≥ 300 mg/day


- Not pregnant or nursing

- Fertile patients must use effective contraception

- Negative pregnancy test

- No known HIV

- ALT or AST ≤ 3 times upper limit of normal

- Oxygen saturation ≥ 93% at room air

- No history of recent acute myocardial infarction

- No history of unstable angina

- No pulmonary decomposition requiring hospitalization within the past 3 months

- No concurrent and/or uncontrolled psychiatric or medical condition that would
preclude study compliance


- See Disease Characteristics

- No prior allogeneic stem cell transplantation

- At least 2 months since other prior experimental therapy

- At least 6 months since prior participation in another vaccine study

- No concurrent systemic immunosuppressive medication

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Toxicity

Outcome Description:

To assess the safety and toxicity of GM-K462 vaccination in CP CML patients who have acheived a complete hematologic response to imatinib.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Martha Wadleigh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

Related Keywords:

  • Leukemia
  • chronic phase chronic myelogenous leukemia
  • Philadelphia chromosome positive chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase



Dana Farber Cancer Institute Boston, Massachusetts  02115