A Clinical trial to assess the effect of Natural Killer Cell transplantation in treatment of patients with Acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL)
One of the most effective methods for boosting innate immune response against cancer is the transfer of natural killer(NK) cells to patients and subsequent activation of these cells with IL-2. In this study, we have one intervention group with 10 people. The purpose of this study is to use these cells to treat cancers, including leukemia. After choosing the appropriate donors who are genetically incompatible in terms of KIR gene, during standard Apheresis, peripheral blood mononuclear cells (PBMCs) are separated from the blood of the donors according to the classic protocol. Several injections of cyclophosphamide and fludarabine chemotherapy drugs will be performed intravenously for 10 patients (CLL & KIR-HLA mismatched donor). Then, the prepared natural killer cells (29 * 106/kg NK ) will be injected to the patients. To stimulate the proliferation and activation of NK-positive cells in the patient's body, repetitive doses of IL-2 (6 doses) will be administrated subcutaneously every 48 hours (one day before injection). In order to evaluate the immune system and the status of NK cells in terms of phenotype and function in the patient's body, on days 2, 7, 14, 21 and 28 after infusion, a sample of peripheral blood will be taken from patients to isolate PBMC. These PBMCs will be cultured in the presence of human IL-2 in a concentration of 200 U/mL. The cells will be incubated for 12 to 16 hours prior to the test. Intracellular IFNγ cytokine production and CD107 marker will be considered as an indicator for activation of the effector cells
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017083027520N9
Registration date:2017-10-19, 1396/07/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-19, 1396/07/27
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Azarbayejan Stem Cell And Regenerative Medicine Institute
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to assess the effect of Natural Killer Cell transplantation in treatment of patients with Acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL)
Public title
Treatment of patients with leukemia using NK cells
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Age range of 18- 25 years for ALL patients; 2-Age range over 50 years for patients with CLL; 3- Those who have a proper cell donors with incongruent KIR (Haploidentical KIR-L mismatched donor); 4- Patients with adequate organ function; 5-Access to the patient for the continuation of treatment and follow-up (preferably from Azeri-speaking patients for easier access and removal of the Zentique variable);
Exclusion criteria : 1-Patients with active and uncontrolled infections; 2-Abnormal kidney, lung and liver function, measured by serum creatinine (serum creatinine> 2 mg / dl), saturated oxygen O2 ≤ 96%) (Sat and liver enzymes (ALT / AST> 2.5 x N); 3-Patients with Down syndrome; 4- Patients with acute promyelocytic leukemia
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
In this study, we have one intervention group with 10 persons
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Stem Cell And Regenerative Medicine Institute,Tabriz University of Medical Sciences
Street address
Stem Cell And Regenerative Medicine Institute, Shahid Madani Hospital, Golbad Ave, Tabriz
City
Tabriz
Postal code
Approval date
2017-08-28, 1396/06/06
Ethics committee reference number
IR.TBZMED.REC.1396.455
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukemia (ALL)
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia
2
Description of health condition studied
Chronic lymphocytic leukemia (CLL)
ICD-10 code
C91.1
ICD-10 code description
Chronic lymphocytic leukaemia
Primary outcomes
1
Description
Phenotype and function of NK cells
Timepoint
2, 7, 14, 21 and 28 days after the transplant
Method of measurement
Flow cytometry
Secondary outcomes
1
Description
IFNγ
Timepoint
2, 7, 14, 21 and 28 days after the transplant
Method of measurement
Flow cytometry
2
Description
CD107
Timepoint
2, 7, 14, 21 and 28 days after the transplant
Method of measurement
Flow cytometry
Intervention groups
1
Description
Injecting 29 * 106 /kg NK cells to patients with leukemia Intravenously and then Injection of Repetitive doses of IL-2 (6 doses) subcutaneously to stimulate the proliferation and activation of NK-positive cells in the patient's body.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Stem Cell And Regenerative Medicine Institute
Full name of responsible person
Mehdi Yousefi
Street address
Stem Cell And Regenerative Medicine Institute, Madani Hospital, Golbad Ave, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Stem Cell And Regenerative Medicine Institute
Full name of responsible person
Mohammad Nouri
Street address
Stem Cell And Regenerative Medicine Institute, Madani Hospital, Golbad Ave, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Stem Cell And Regenerative Medicine Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Stem Cell And Regenerative Medicine Institute
Full name of responsible person
Leili Aghebati Maleki
Position
PhD of Medical Immunology
Other areas of specialty/work
Street address
Stem Cell And Regenerative Medicine Institute, Madani Hospital, Golbad Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3336 4665
Fax
Email
leili_aghebati_maleki@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Stem Cell And Regenerative Medicine Institute
Full name of responsible person
Mehdi Yousefi
Position
PhD of Immunology
Other areas of specialty/work
Street address
Stem Cell And Regenerative Medicine Institute, Madani Hospital,Golbad Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3336 4665
Fax
Email
mehdi_yusefi@yahoo.comyousefime@tbzmed.c.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sanam Dolati
Position
PhD of Immunology
Other areas of specialty/work
Street address
Department of Immunology, Faculty of Medicine, Tabriz, Iran
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)