Clinical Study of DC-AML Cells in the Treatment of Acute Myeloid Leukemia

Summary

The primary aim of this innovative immunotherapy using WT1/hTERT/Survivin-loaded DCs is to determine whether this novel DC vaccination is safe and can significantly prevent clinical relapse and increase survival of acute myeloid leukemia (AML) patients by eradicating minimal residual disease, while maintaining its safety profile in this phase I trial.

Eligibility

Inclusion Criteria:

* Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO).
* Patients completed induction and consolidation chemotherapy and have achieved complete remission (CR) by bone marrow biopsy criteria but with persistent MRD (defined by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) and are not eligible for stem cell transplant
* Patients have MRD molecular relapse (defined by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) after achieved CR following induction and consolidation chemotherapy.
* Patients with molecular relapse (define by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) after allogeneic stem cell transplant
* Leukemic cells express at least one of the following antigens: WT1, hTERT or survivin detected by qRT-PCR and/or flow cytometry or immunohistochemistry
* Karnofsky PS ≥60% or ECOG PS≤2.
* Patients must have organ and marrow function as defined below:

  * leukocytes \>=3,000/mcL
  * absolute neutrophil count \>=1,500/mcL
  * platelets \>=100,000/mcL
  * hemoglobin \>=9.0 g/dL
  * total bilirubin within normal institutional limits except in patients with Gilberts Syndrome who must have a total bilirubin \< 3.0 mg/dL
  * AST(SGOT)/ALT(SGPT) Serum ALT/AST \< 2.5X ULN
  * creatinine clearance Calculated creatinine clearance (CrCl) \>=50 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
  * Adequate cardiac function: LVEF ≥50% by MUGA
* Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participation in any other interventional clinical trial during the study period.
* History or concomitant presence of any other malignancy, except for any other effectively treated malignancy that has been in remission for \>5 years or that is highly likely to be cured at the time of enrollment.
* Patients with a second invasive malignancy requiring treatment within the last 2 years are not eligible.
* Patients with any form of systemic immunodeficiency, including AIDS or primary immunodeficiency such as Severe Combined Immunodeficiency Disease, are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the treatment.
* Active hepatitis B, C infection
* Patients on immunosuppressive drugs including corticosteroids.
* Patients with autoimmune diseases such as Crohn s disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements.
* Allergic to human albumin or IL-2. History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
* Pregnant or breast-feeding.

Conditions2

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