Safety and Feasibility Study of Dendritic Cell (DC) Vaccination Expressing WT1/hTERT/Survivin in AML Patients With Minimal Residual Disease (MRD)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Department of hematology
RECRUITING
Beijing
Contact Information
Primary
Sun Yao, M.D.,Ph.D.
suny320@126.com
010-66947402
Backup
Wang Yu xin, M.D.
wyx15147159987@163.com
010-66947109
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 20
Treatments
Experimental: DC vaccine
Vaccination with autologous or HLA-matched donors' WT1/TERT/survivin loaded DCs plus follow-up care.
Related Therapeutic Areas
Sponsors
Leads: Affiliated Hospital to Academy of Military Medical Sciences

This content was sourced from clinicaltrials.gov

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