Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "Dainippon Sumitomo Phama(DSP)-7888" for Acute Myeloid Leukemia Patients.

  • STATUS
    Recruiting
  • End date
    Apr 14, 2024
  • participants needed
    100
  • sponsor
    Osaka University
Updated on 14 March 2021

Summary

This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological complete remission (CR). DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize Wilms Tumor Gene 1 (WT1) peptides.

Description

This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological CR. DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides. Primary endpoint is relapse-free survival, and 2nd endpoint is hematological relapse-free survival, overall survival and adverse event.

Details
Condition Acute Myeloid Leukemia in Remission
Treatment DSP-7888
Clinical Study IdentifierNCT04747002
SponsorOsaka University
Last Modified on14 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification
favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification
1st hematological after chemotherapy
Human Leukocyte Antigen (HLA)-A02:01, 02:06, 24:02
20-80 years old
Eastern Cooperative Oncology Group (ECOG) performance Status 0-2
within 35 days after White Blood Cell (WBC) and Neutrophil recovers over 1500 and 500, respectively
sufficient organ function as below within 7 days
(1) Neutrophil : >= 1000 (2) Cr : >= 3.0mg/dl (3) Aspartate aminotransferase
(AST), Alanine transaminase (ALT) : 5 x the upper limit of normal (ULN) for
the reference lab (4) Percutaneous oxygen saturation (SpO2): >= 95% 9)
patients who agree contraception until 6 months after the last injection 10)
non-candidate for hematopoietic stem cell transplantation
illegible for hematopoietic stem cell transplantation (HSCT)
lack of appropriate donor
patients who don't select HSCT at the 1st hematological complete remission (hCR) timing

Exclusion Criteria

multiple primary cancer
autoimmune disease
usage of investigational or unapproved drug within 28 days
severe organ failure
Human Immunodeficiency Virus (HIV) antibody / Hepatitis B surface (HBs) antigen / Hepatitis C Virus (HCV) antibody positive
pregnant woman
lactating woman
under treatment against active infection
other reasons which investigator judge appropriate for enrollment
difficult to enroll because of mental problem
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note