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Comparative study of the therapeutic results of Carboplatin, Etoposide, ARAC, Melfalan chemotherapy regimes with CCNU, Etoposide, ARAC, Melfalan diet as a diet before autologous stem cell transplantation in patients with resistant / recurrent lymphoma

Protocol summary

Study aim
Determining and comparing the therapeutic results of different chemotherapy regimens before autologous stem cell transplantation in patients with resistant/relapsed lymphoma.
Design
Clinical trial, with parallel groups, without blinding, non-randomized, phase 2 on 44 patients.
Settings and conduct
In this non-blinded, non-randomized clinical trial study, 44 patients with resistant/relapsed lymphoma, referring to Omid Hospital in Isfahan, were enrolled in 2 groups. In two groups, heavy conditioning will be done under two chemotherapy regimens. Then patients undergo autologous stem cell transplantation. After Engraft, the patient is discharged. Then the transplant complications and the possibility of disease recurrence will be evaluated in two ways.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being over 18 years old, having Hodgkin's/Non-Hodgkin's lymphoma resistant/relapsed and consenting to participate in the study. Exclusion criteria include patients who do not have suitable stem cells for transplantation during the initial stages of stem cell transplantation.
Intervention groups
First intervention group: First, the patient undergoes mobilization. Then the stem cells are separated from the peripheral blood. At this stage, the patient is treated with heavy conditioning chemotherapy including Etoposide, ARAC, Melphalan and Carboplatin. Second intervention group: First, the patient undergoes mobilization. Then the stem cells are separated from the peripheral blood. At this stage, the patient is treated with heavy conditioning chemotherapy including Etoposide, ARAC, Melphalan and CCNU.
Main outcome variables
Transplant complications, disease recurrence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N70
Registration date: 2023-09-06, 1402/06/15
Registration timing: registered_while_recruiting

Last update: 2023-09-06, 1402/06/15
Update count: 0
Registration date
2023-09-06, 1402/06/15
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-21, 1402/04/30
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the therapeutic results of Carboplatin, Etoposide, ARAC, Melfalan chemotherapy regimes with CCNU, Etoposide, ARAC, Melfalan diet as a diet before autologous stem cell transplantation in patients with resistant / recurrent lymphoma
Public title
Comparative study of treatment results of different chemotherapy in patients with lymphoma cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years Having Hodgkin/non-Hodgkin of lymphoma resistant/relapsed Consent to participate in the study
Exclusion criteria:
Patients who do not have suitable stem cells for transplantation during the initial stages of stem cell transplantation
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Not randomized
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 Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-11-24, 1399/09/04
Ethics committee reference number
IR.MUI.MED.REC.1399.754

Health conditions studied

1

Description of health condition studied
Hodgkin lymphoma
ICD-10 code
C81.9
ICD-10 code description
Hodgkin lymphoma, unspecified

2

Description of health condition studied
Non Hodgkin lymphoma
ICD-10 code
C85.90
ICD-10 code description
Non-Hodgkin lymphoma, unspecified, unspecified site

Primary outcomes

1

Description
Transplant complications
Timepoint
From the time of intervention every two weeks, then every one month, and then every two months until finally one year
Method of measurement
Observation

2

Description
Survival
Timepoint
Up to one year after transplantation
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: First, the patient undergoes mobilization (stimulation of stem cells to move from the BM side to the peripheral blood by means of GCSF medicine). Then stem cells are separated from peripheral blood by OPTIA device with apheresis technique. At this stage, the patient is being treated with heavy conditioning chemotherapy including Etoposide 300 mg/m2 (2 to 3 days), ARAC 300 mg/m2 (2 to 3 days), Melphalan 140 mg/m2 (1 day). and Carboplatin 750 mg/m2 (2 to 3 days) is placed.
Category
Treatment - Drugs

2

Description
Second intervention group: First, the patient undergoes mobilization (stimulation of stem cells to move from the BM to the peripheral blood by means of GCSF). Then stem cells are separated from peripheral blood by OPTIA device with apheresis technique. At this stage, the patient is being treated with heavy conditioning chemotherapy including Etoposide 300 mg/m2 (2 to 3 days), ARAC 300 mg/m2 (2 to 3 days), Melphalan 140 mg/m2 (1 day). and CCNU is placed at 200 mg/m2 (4 days).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyed Al Shahada Hospital of Isfahan
Full name of responsible person
Alireza Sadeghi
Street address
Seyed Al Shahada Hospital, Farshadi River Alley, Khayyam Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3235 0218
Email
sadeghi_hem@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Sadeghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Seyed Al Shahada Hospital, Farshadi River Alley, Khayyam Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3235 0218
Fax
Email
sadeghi_hem@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Sadeghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Seyed Al Shahada Hospital, Farshadi River Alley, Khayyam Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3235 0218
Fax
Email
sadeghi_hem@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Yaser Salehi najafabadi
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Hematology
Street address
Seyed Al Shahada Hospital, Farshadi River Alley, Khayyam Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3235 0218
Fax
Email
dr.y.salehi@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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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