Prophylactic administration of Natural Killer cells early after hematopoietic stem cell transplantation in adult patients with high-risk acute myeloid leukemia
To assess the safety and efficacy of Prophylactic administration of Natural Killer cells early after hematopoietic stem cell transplantation in adult patients with high-risk acute myeloid leukemia
Design
This is a non-randomized, interventional, single-group assignment study to assess the safety and feasibility of an allogeneic NK cell therapy on ten patients with high-risk acute myeloid leukemia who are candidates for allogeneic hematopoietic stem cell transplantation.
Settings and conduct
The study is a single-group clinical trial to evaluate the safety and efficacy of Prophylactic administration of Natural Killer cells early after hematopoietic stem cell transplantation in adult patients with high-risk acute myeloid leukemia at the Hematology-Oncology-Stem Cell Transplantation Research Center (HORCSCT) of Tehran University.
Participants/Inclusion and exclusion criteria
Patients over and equal to 18 years of age with high-risk acute myeloid leukemia who are candidates for allogeneic hematopoietic stem cell transplantation from matched or mismatched donors are included in the study. Patients with uncontrolled infection or severe acute graft-versus-host disease are excluded from the study
Intervention groups
All patients will be assigned to the only interventional arm of the study. Recipients of allogeneic Stem Cell Transplantation will receive the systemic intravenous infusion of natural killer cells at days +6 and +12 post-transplantation.
Main outcome variables
Natural Killer cell infusion-related Adverse Events, Relapse incidence for one year after infusion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140818018842N35
Registration date:2023-07-13, 1402/04/22
Registration timing:prospective
Last update:2023-07-13, 1402/04/22
Update count:0
Registration date
2023-07-13, 1402/04/22
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2635
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic administration of Natural Killer cells early after hematopoietic stem cell transplantation in adult patients with high-risk acute myeloid leukemia
Public title
Natural Killer cell in acute myeloid leukemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years old or more
Recipients of allogeneic Stem Cell Transplantation for high-risk Acute Myeloid Leukemia by ELN classification
Recipients of allogeneic Stem Cell Transplantation from matched or mismatched donors.
MRD ≥ 5% after the first Induction or MRD ≥ 0.1% after the second Induction or MRD ≥ 0.01% before transplantation
Normal organ function
Exclusion criteria:
Second allogeneic Stem Cell Transplantation
Active or uncontrolled infection
Acute graft versus host disease
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran Univer
Street address
Kargar shomali Ave., Shariati hospital
City
Tehran
Province
Tehran
Postal code
1411713131
Approval date
2022-08-11, 1401/05/20
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1401.011
Health conditions studied
1
Description of health condition studied
acute myeloid leukemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukemia
Primary outcomes
1
Description
Number of Patients With Grades 3-5 of Natural Killer cell infusion-related Adverse Events
Timepoint
Daily during the first seven days after the injection
Method of measurement
History, Physical exam, and lab test
2
Description
Relapse Incidence
Timepoint
one year after infusion
Method of measurement
Bone marrow aspiration and biopsy
Secondary outcomes
empty
Intervention groups
1
Description
All patients are included in the only intervention arm of the study. Patients in the intervention arm will receive two doses of in-vitro expanded NK cells at the 6 and 12 days after transplantation under full supervision and in an isolated room. The process of isolation and preparation of NK cells will be done in a clean room with clinical grade and suitable conditions for producing NK cells. 20 to 30 cc of peripheral blood was taken from the third-party donor and after the isolation of mononuclear cells, CD56+/CD3- reproduced. A viability test is done using trypan blue and phenotyping is used to check the absolute number and purity of cells.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci
Full name of responsible person
Maryam Barkhordar
Street address
North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1417713135
Phone
+98 21 8800 4140
Email
barkhordarm.n@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Ahmadvand
Street address
Kargar-e-Shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 913 185 6733
Email
ahmadvand.mohamad64@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Barkhordar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Kargar-e-Shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8800 4140
Email
barkhordarm.n@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad ٰVaezi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Kargar-e-Shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8800 4140
Email
vaezi.mohammad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Barkhordar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Kargar-e-Shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8800 4140
Email
barkhordarm.n@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD