Status:

RECRUITING

DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML

Lead Sponsor:

Affiliated Hospital to Academy of Military Medical Sciences

Conditions:

High-risk Soft Tissue Sarcoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with AML. Experimental recombinant...

Eligibility Criteria

Inclusion

  • Consistent with the diagnosis of AML
  • Age≥18 years at time of consent
  • KPS(Karnofsky Performance Scale) ≥70
  • Patient's written informed consent
  • No steroid therapy within 4 weeks of first DC vaccination
  • Stable disease, complete response and partial response(WHO, RECIST)
  • Predicted survival≥3 months

Exclusion

  • Serious dysfunction of vital organs(heart, liver or kidney)
  • Received organ transplantation
  • Patients with other malignancies or brain metastases
  • History of autoimmune diseases
  • Pregnant and breast-feeding patient
  • Active or chronic infectious diseases
  • History of allergy or hypersensitivity to study product excipients
  • Currently participating in another clinical trial
  • Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks
  • Unfit for participating in this clinical trial in investigators' opinions

Key Trial Info

Start Date :

June 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2024

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT01898663

Start Date

June 1 2013

End Date

December 30 2024

Last Update

July 1 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Department of Hematopoietic Stem Cell Transplantation

Beijing, China, 100071

DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML | DecenTrialz