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Safety and efficacy of cell therapy with allogeneic natural killer cells activated with interleukin 2 and 15 in patients with refractory non-M3 acute myeloid leukemia (absence of hematological, morphological or molecular response after at least two treatment regimens)

Protocol summary

Study aim
Safety and efficacy of cell therapy with allogeneic natural killer cells activated with interleukin 2 and 15 in patients with acute myeloid leukemia (non-M3) to negate the minimal residual disease.
Design
Un-randomized, open-labeled Sample size: 12, taking into account the loss: 15 Phase I and
Settings and conduct
NK cell therapy in acute myeloid leukemia (non-M3) patients in Taleghani Hospital. Donor leukopheresis is performed without mobilization. NK cells are carried out using the Milteney CD56+ enrichment kit. Isolated NK cells are activated using interleukin 2 and 15. The activated NK cells will be injected into the patients and its safety and efficiency as well as minimal residual disease will be evaluated in a period of six months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with acute myeloid leukemia(non-M3) diagnosed according to the World Health Organization classification; Inadequate response to induction therapy (incomplete or complete remission with minimal positive residual disease);Relapse (hematologic, morphologic or positive minimal residual disease); Karnofsky index above 70% Exclusion criteria: Patients with acute myeloid leukemia-M3; Patients with low-risk acute myeloid leukemia; Patients in complete molecular remission
Intervention groups
Single group, Cell therapy with allogeneic natural killer cells activated with interleukin 2 and 15
Main outcome variables
The percentage of patients who show adverse effects during or after NK cell therapy. Overall survival in patients after NK cell therapy. Response to treatment ( complete remission based on hematologic, morphologic and molecular assessments)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230801058996N3
Registration date: 2023-10-07, 1402/07/15
Registration timing: registered_while_recruiting

Last update: 2023-10-07, 1402/07/15
Update count: 0
Registration date
2023-10-07, 1402/07/15
Registrant information
Name
Elham Roshandel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5798 4000
Email address
elham.roshandel@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-22, 1402/06/31
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of cell therapy with allogeneic natural killer cells activated with interleukin 2 and 15 in patients with refractory non-M3 acute myeloid leukemia (absence of hematological, morphological or molecular response after at least two treatment regimens)
Public title
Activated NK cell therapy to negate MRD in AML patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute myeloid leukemia(non-M3) diagnosed according to the World Health Organization classification Inadequate response to induction therapy (incomplete or complete remission with minimal positive residual disease) Relapse (Hematologic, morphologic or positive minimal residual disease) Karnofsky index above 70%
Exclusion criteria:
Patients with acute myeloid leukemia-M3 Patients with low-risk acute myeloid leukemia Patients in complete molecular remission
Age
From 12 years old to 80 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 15
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
Ethics committee of Shahid Beheshti University of medical Sciences
Street address
Taleghani Hospital, Aarabi street, Yaman street, Chamran highway
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.153

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
The percentage of adverse effects during or after NK cell therapy.
Timepoint
From the first dose of NK cells infusion until six months after its last dose.
Method of measurement
The patient's statements and the medical team's examinations during the patient's regular visits to the bone marrow transplantation clinic for follow-up.

2

Description
Response to treatment (Based on hematologic, morphologic and molecular assessments).
Timepoint
From the first dose of NK cells infusion until six months after its last dose.
Method of measurement
Regular patient examination in bone marrow transplantation clinic for follow-up

Secondary outcomes

1

Description
Evaluation of "Event Free Survival" in a six month period.
Timepoint
From the first dose of NK cells infusion until six months after its last dose.
Method of measurement
Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients.

2

Description
Evaluation of "Progression free survival" in a six month period.
Timepoint
From the first dose of NK cells infusion until six months after its last dose.
Method of measurement
Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients.

3

Description
Evaluation of "non-relapse mortality" in a six month period.
Timepoint
From the first dose of NK cells infusion until six months after its last dose
Method of measurement
Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients.

4

Description
Evaluation of "Overall survival" in a six month period.
Timepoint
From the first dose of NK cells infusion until six months after its last dose
Method of measurement
Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients.

Intervention groups

1

Description
Intervention group: patients with acute myeloid leukemia (other than M3) undergo cell therapy with allogeneic natural killer cells activated with interleukin 2 and 15. First, the allogeneic donor is undergo apheresis to isolate mononuclear cells. Then the NK cells are enriched from the apheresis product using the CliniMacs device. These cells are incubated overnight with interleukin 2 and 15 to activate. Activated cells are injected into patients in three incremental doses of one, three, and five million cells per kilogram of body weight, respectively.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Elham Roshandel
Street address
Taleghani Hospital, Aarabi street, Yaman street, Chamran highway
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Phone
+98 21 2303 1658
Fax
+98 21 2303 1658
Email
info@sbmu.ac.ir
Web page address
https://taleghani.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Aarabi street, Daneshjou Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9872
Fax
+98 21 2243 9872
Email
info@sbmu.ac.ir
Web page address
https://sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Javidan Motaher Charity Foundation of Tehran
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Aarabi street, Daneshjou Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9872
Fax
+98 21 2243 9872
Email
info@sbmu.ac.ir
Web page address
https://sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Pharmed Behin Azma
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Roshandel
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cell therapy
Street address
Taleghani Hospital, Aarabi street, Yaman street, Chamran highway
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Phone
+98 21 2303 1658
Fax
+98 21 2303 1658
Email
elham.roshandel@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Roshandel
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cell therapy
Street address
Taleghani Hospital, Aarabi street, Yaman street, Chamran highway
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Phone
+98 21 2303 1658
Fax
+98 21 2303 1658
Email
elham.roshandel@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Roshandel
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cell therapy
Street address
Taleghani Hospital, Aarabi street, Yaman street, Chamran highway
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Phone
+98 21 2303 1658
Fax
+98 21 2303 1658
Email
elham.roshandel@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
Due to the confidentiality of patient information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Diagnosis: based on peripheral blood and bone marrow morphology, immunophenotyping, karyotype, and molecular tests. Treatment: chemotherapy, immunotherapy and hematopoietic cell transplantation. The results of peripheral blood and bone marrow tests, flow cytometry, polymerase chain reaction and minimal residual disease before the intervention, after the last intervention, and on the 90th day after the intervention. All potential patient data can be shared after de-identifying them.
When the data will become available and for how long
Data files would be accessible after publication.
To whom data/document is available
Data files would be accessible to both academic researchers and industrial developers.
Under which criteria data/document could be used
Access to the data file will be provided for academic researchers to study. Data analysis is possible for use in meta-analysis review articles. Authentication of the applicant and provision of an academic email is required to access the data file.
From where data/document is obtainable
To receive the data file, please refer to the person in charge of the trial (Dr. Elham Roshandel): E-mail: elham.roshandel@gmail.com Phone number: 00982123031658 Address: Hematopoietic stem cell research center, Yas administrative complex, 4th floor, Taleghani Hospital, Aarabi street, Yaman street, Chamran highway, Tehran.
What processes are involved for a request to access data/document
The applicant must state his/her request accurately and completely. The requested data will be provided within ten working days after receiving the request.
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