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Safety and efficacy of combination therapy with rituximab and activated allogeneic haplo-identical natural killer cells in relapsed/refractory non-Hodgkin's lymphoma patients

Protocol summary

Study aim
Safety and efficacy of combination therapy with rituximab and activated allogeneic haplo-identical natural killer cells in relapsed/refractory non-Hodgkin's lymphoma patients
Design
Clinical trial with control group, Un-randomized, open-labeled Sample size: 12, taking into account the loss: 15 Phase I and
Settings and conduct
Patients with relapsed/refractory non-Hodgkin's lymphomas referred to Taleghani Hospital, receiving combination therapy with rituximab (375mg/m2 intravenously) and haplo-identical allogeneic activated NK cells (with doses of 1x106 cells/kg, 5x106 cells/kg, 1x107 cells/kg and 1x107 cells/kg on days 0, 14, 28 and 42) after chemotherapy regimen of lymphocyte depletion including cyclophosphamide (250mg/m2 intravenously) and fludarabine (25mg/m2 intravenously).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with non-Hodgkin's lymphomas with the origin of B lymphocytes; patients with non-response or insufficient response to the first stage of treatment; patients with disease recurrence. Exclusion criteria: Non-Hodgkin's B-cell lymphomas patients with clinical and paraclinical full recovery; Non-Hodgkin's B-cell lymphomas patients with clinical and paraclinical appropriate response to the first stage of treatment.
Intervention groups
Intervention group: 6 patients with relapsed/refractory non-Hodgkin's lymphomas receiving combination therapy with rituximab and haplo-identical allogeneic activated NK cells. Control group: Patients with relapsed/refractory non-Hodgkin's lymphomas receiving only rituximab.
Main outcome variables
The adverse effects during or after combination therapy with allogeneic NK cells and rituximab.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230801058996N6
Registration date: 2024-06-26, 1403/04/06
Registration timing: registered_while_recruiting

Last update: 2024-06-26, 1403/04/06
Update count: 0
Registration date
2024-06-26, 1403/04/06
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
2024-06-21, 1403/04/01
Expected recruitment end date
2026-06-22, 1405/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of combination therapy with rituximab and activated allogeneic haplo-identical natural killer cells in relapsed/refractory non-Hodgkin's lymphoma patients
Public title
Combination therapy with rituximab and allogeneic natural killer cells in -Hodgkin's lymphoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-Hodgkin's lymphomas with the origin of B lymphocytes confirmed based on WHO criteria and clinical and paraclinical evidence Patients with non-response or insufficient response to the first stage of treatment based on clinical and paraclinical evidence Patients with disease recurrence Patients with ECOG index of 0-2
Exclusion criteria:
Non-Hodgkin's B-cell lymphomas Patients with clinical and paraclinical full recovery Non-Hodgkin's B-cell lymphomas Patients with clinical and paraclinical appropriate response to the first stage of treatment
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
Parallel
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
Aarabi street, Yaman street, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2024-04-28, 1403/02/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.037

Health conditions studied

1

Description of health condition studied
Relapsed/refractory non-Hodgkin's lymphoma
ICD-10 code
C85
ICD-10 code description
Other and unspecified types of non-Hodgkin lymphoma

Primary outcomes

1

Description
The adverse effects during or after combination therapy with allogeneic NK cells and rituximab.
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
Event Free Survival
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
Progression free survival
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
Non-relapse mortality
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
Overall survival
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 relapsed/refractory non-Hodgkin's lymphomas referred to Taleghani Hospital. 6 patients in the intervention group receiving combination therapy with rituximab and haplo-identical allogeneic activated NK cells. Before the start of cell therapy, in order to remove the host's lymphocyte cells, the chemotherapy regimen of lymphocyte depletion including cyclophosphamide (250mg/m2 intravenously) and fludarabine (25mg/m2 intravenously) is performed for the patients. Patients receive rituximab drug (375mg/m2 intravenously) weekly and on the day before receiving NK cells. Activated NK cells are injected with doses of 1x106 cells/kg, 5x106 cells/kg, 1x107 cells/kg and 1x107 cells/kg on days 0, 14, 28 and 42. Also, during the treatment period, patients will be treated with preventive medicine. Up to 4 cycles of the maintenance regimen are allowed.
Category
Treatment - Other

2

Description
Control group: Patients with relapsed/refractory non-Hodgkin's lymphomas referred to Taleghani Hospital. Patients in the control group received only rituximab (375mg/m2 intravenously). Also, during the treatment period, patients will be treated with preventive medicine. Up to 4 cycles of the maintenance regimen are allowed.
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
Pharmed Behin Azma
Proportion provided by this source
100
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
1985717443
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
1985711151
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
1985717443
Phone
+98 21 2303 1658
Fax
+98 21 2303 1658
Email
elham.roshandel@gmail.com
Web page address

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. 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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