Safety and efficacy of modified donor lymphocyte infusion (DLI) in reducing infection risk in adult patients with acute leukemia following allogeneic hematopoietic stem cell transplantation
Evaluation of safety and efficacy of modified donor lymphocyte infusion (DLI) in reducing infection risk in adult patients with acute leukemia following allogeneic hematopoietic stem cell transplantation
Design
clinical trial with control group, parallel groups, Un-randomized, open-labeled Sample size: 12, taking into account the loss: 15, Phase I and II
Settings and conduct
Patients with acute leukemia referred to Taleghani Hospital receive hematopoietic stem cell transplantation from a haplotype donor in the form of T cell replete with cyclophosphamide (Ptcy) and then modified DLI with time intervals of 4-6 weeks with increasing doses of 0.5 x 106, 106 x They receive 1 and 106 x 3 via peripheral vein catheter. Then clinical symptoms, laboratory tests for viral infections, laboratory tests for bacterial and fungal infections in case of clinical symptoms will perform rom the first dose of modified DLI infusion until one year after its last dose on days 90, 180, and 360.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Transplantation of T cell replete haplotype with cyclophosphamide/The estimated life expectancy more than one year/Karnofsky index above 70%
Exclusion criteria: GVHD of grade 2 or less/Uncontrolled bacterial infection/Insufficient intake: WBC<2500/mm3 and Platelet<50000/mm3/Evidence of recurrence/Concomitant treatment with corticosteroids and/or other immunosuppressive drugs/Infection with hepatitis B, C and HIV pathogens
Intervention groups
Intervention group: Acute leukemia patients receive T cell repleted hematopoietic stem cell transplantation from a haplotype donor with cyclophosphamide (Ptcy) and then receive modified DLI.
Control group: Acute leukemia patients only receive T cell repleted hematopoietic stem cell transplantation from a haplotype donor with cyclophosphamide (Ptcy).
Main outcome variables
Infection rate after treatment with modified DLI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230801058996N4
Registration date:2024-06-19, 1403/03/30
Registration timing:prospective
Last update:2024-06-19, 1403/03/30
Update count:0
Registration date
2024-06-19, 1403/03/30
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
recruiting
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2027-07-06, 1406/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of modified donor lymphocyte infusion (DLI) in reducing infection risk in adult patients with acute leukemia following allogeneic hematopoietic stem cell transplantation
Public title
Reducing infection risk in adult patients with acute leukemia using modified donor lymphocyte infusion (DLI) following allogeneic hematopoietic stem cell transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Transplantation of T cell replete haplotype with cyclophosphamide
The estimated life expectancy more than one year
Karnofsky index above 70%
Exclusion criteria:
GVHD of grade 2 or less
Uncontrolled bacterial infection
Insufficient intake: WBC<2500/mm3 and Platelet<50000/mm3
Evidence of recurrence
Concomitant treatment with corticosteroids and/or other immunosuppressive drugs
Infection with hepatitis B, C and HIV pathogens
From the first dose of modified DLI infusion until one year after its last dose on days 90, 180, and 360.
Method of measurement
Examining clinical symptoms, performing laboratory tests for viral infections, performing laboratory tests for bacterial and fungal infections in case of clinical symptoms.
Secondary outcomes
1
Description
Evaluation of "Overall survival" in a one year period.
Timepoint
From the first dose of modified DLI infusion until one year 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: Acute leukemia patients receive T cell repleted hematopoietic stem cell transplantation from a haplotype donor with cyclophosphamide (Ptcy) and then modified DLI with time intervals of 4-6 weeks with escalating doses of 0.5 x 106, 1 x 106 and 3 x 106 they receive.
Category
Treatment - Other
2
Description
Control group: Acute leukemia patients only receive T cell repleted hematopoietic stem cell transplantation from a haplotype donor with cyclophosphamide (Ptcy).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Elham Roshandel
Street address
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
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
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
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
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
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
Clinical symptoms, Laboratory tests for viral infections, Laboratory tests for bacterial and fungal infections in case of clinical symptoms.
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.