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

NCT05000801 | Recruiting

• 1 other identifier: 307-DC-1911
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• the Incidence of Treatment Adverse Events

  To determine the safety of autologous/or HLA-matched DCs loaded with WT1/TERT/Survivin. The primary objective of this single-arm phase I clinical study is to determine the safety and feasibility of WT1/TERT/survivin-targeted DC vaccination in adult AML patients with MRD at very high risk of relapse.

  through study completion,an average of 3 years

Secondary Outcomes (5)

• OS

  through study completion,an average of 3 years

• Complete MRD response rate

  through study completion,an average of 3 years

• Relapse rate

  through study completion,an average of 3 years

• Relapse-free survival

  through study completion,an average of 3 years

• Change in WT1 mRNA levels from peripheral blood samples and/or bone marrow biopsy samples.

  through study completion,an average of 3 years

Study Arms (1)

DC vaccine

EXPERIMENTAL

Vaccination with autologous or HLA-matched donors' WT1/TERT/survivin loaded DCs plus follow-up care.

Biological: DC vaccine

Interventions

DC vaccine BIOLOGICAL

Autologous/or HLA-matched donors' DCs loaded with WT1/TERT/survivin

DC vaccine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

Department of hematology

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

lentiviral minigene vaccine of COVID-19 coronavirus

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Liangding Hu, M.D.

  the Fifth Medical Center the PLA General Hospital

  STUDY DIRECTOR

• Liangding Hu, M.D.

  the Fifth Medical Center the PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Yao, M.D.,Ph.D.

CONTACT

010-66947402; suny320@126.com

Wang Yu xin, M.D.

CONTACT

010-66947109; wyx15147159987@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 11, 2021
• Study Start: July 1, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

CN (1)