Evaluation of the efficacy of a tiotepa-based regimen for allogeneic transplantation in patients with acute lymphoblastic leukemia: a prospective single arm study.
The purpose of this study is to test the efficacy of a tiotepa-based regimen for allogeneic transplantation in patients with acute lymphoblastic leukemia.
Design
This is a prospective single arm study and 31 adult patients with acute lymphoblastic leukemia who are candidates for transplant will be transplanted with thiotepa-based regimen and the results will be compared retrospectively through matched pairs analysis.
Settings and conduct
Acute lymphblastic leukemia patients candidates for allogeneic transplantation are admitted at the hematopoietic stem cell transplant department of Shariati Hospital and will receive the conditioning regimen and will be transplanted.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients from 18 to 65 years old, with acute lymphoblastic leukemia. Exclusion criteria: Symptomatic coronary artery disease, Karnofsky Performance Score < 60, patients with uncontrolled bacterial, viral or fungal infection, females who are pregnant or breastfeeding.
Intervention groups
Intervention group: Fludarabin (ACTOVERCO) 30 mg/m2, Day -7 to -4, Busulfan (Nanoalvand) 3.2 mg/kg/D, Day -7 and -4, Thiotepa (Nanoalvand) 5 mg/kg/D IV day -3 and -2.
Main outcome variables
One year overall survival, incidence of relapse, incidence of transplant related mortality, incidence of acute and chronic graft versus host disease.
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20140818018842N39
Registration date:2024-05-12, 1403/02/23
Registration timing:registered_while_recruiting
Last update:2024-05-12, 1403/02/23
Update count:0
Registration date
2024-05-12, 1403/02/23
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2635
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of a tiotepa-based regimen for allogeneic transplantation in patients with acute lymphoblastic leukemia: a prospective single arm study.
Public title
Efficacy of Tiothepa in hematopoietic stem cell transplantation in acute lymphoblastic leukemia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with acute lymphoblastic leukemia
Exclusion criteria:
symptomatic coronary artery disease
karnofsky Performance Score < 60
patients with uncontrolled bacterial, viral or fungal infection
females who are pregnant or breastfeeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
31
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
Ethic committee of Hematology- Oncology and cell therapy Research Institute, Tehran University of Me
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2024-02-27, 1402/12/08
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1403.007
Health conditions studied
1
Description of health condition studied
acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
Primary outcomes
1
Description
overall survival
Timepoint
Monthly for 12 months after transplantation
Method of measurement
Visiting the patient and performing monthly lab tests in outpatient clinique
Secondary outcomes
1
Description
Relapse incidence
Timepoint
Monthly for 12 months after transplantation
Method of measurement
Visiting the patient in person and performing bone marrow biopsy and monthly lab tests in outpatient clinique
2
Description
Incidence of acute graft versus host disease
Timepoint
Monthly for 4 months after transplantation
Method of measurement
Visiting the patient in person and performing monthly lab tests in outpatient clinique
3
Description
Incidence of chronic graft versus host disease
Timepoint
Monthly for 12 months after transplantation
Method of measurement
Visiting the patient in person and performing monthly lab tests in outpatient clinique
4
Description
Transplant Related Mortality
Timepoint
Monthly for 12 months after transplantation
Method of measurement
Visiting the patient in person and performing monthly lab tests in outpatient clinique
Intervention groups
1
Description
Intervention group: Fludarabin (ACTOVERCO) 30 mg/m2, Day -7 to -4, Busulfan (Nanoalvand) 3.2 mg/kg/D, Day -7 and -4, Thiotepa (Nanoalvand) 5 mg/kg/D IV day -3 and -2.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences
Full name of responsible person
Tanaz Sayar Bahri
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
14117 13135
Phone
+98 21 8800 4140
Email
tanaz.bahri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbari Sari
Street address
Poursina St., 16 Azar St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 81631
Email
akbarisari@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Leyla Sharifi Aliabadi
Position
Research Assistant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1417713135
Phone
00982288004140
Email
ctu@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tanaz Sayar Bahri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Shariati Hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
-
Email
tanaz.bahri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tanaz Sayar Bahri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Email
tanaz.bahri@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