| CTRI Number |
CTRI/2021/12/038469 [Registered on: 07/12/2021] Trial Registered Prospectively |
| Last Modified On: |
02/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Analysing the Graft versus host disease in allogenic stem cell transplant patient by adding with or without sitagliptin. |
|
Scientific Title of Study
|
Open labelled, randomized controlled trial of All allogenic hematopoietic stem cell transplantation (HSCT) with standard graft versus host disease (GVHD) prophylaxis with or without sitagliptin. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sachin Suresh Jadhav |
| Designation |
Group Head Hematology and SCT |
| Affiliation |
HCG Cancer Hospital, bangalore |
| Address |
Tower 1 OPD Room No-1
HCG Cancer Hospital
Department-Hematology and BMT
Division_Hematology and BMT
No.8 P kalinga rao road
sampangiram road,
Bangalore-560027
Bangalore
KARNATAKA
560027
India |
| Phone |
9741351357 |
| Fax |
|
| Email |
drsachinjadhav@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Suresh Jadhav |
| Designation |
Group Head Hematology and SCT |
| Affiliation |
HCG Cancer Hospital, bangalore |
| Address |
Tower 1 OPD Room No-1
HCG Cancer Hospital
Department-Hematology and BMT
Division_Hematology and BMT
No.8 P kalinga rao road
sampangiram road,
Bangalore-560027
Bangalore
KARNATAKA
560027
India |
| Phone |
9741351357 |
| Fax |
|
| Email |
drsachinjadhav@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Suresh Jadhav |
| Designation |
Group Head Hematology and SCT |
| Affiliation |
HCG Cancer Hospital, bangalore |
| Address |
Tower 1 OPD Room No-1
HCG Cancer Hospital
Department-Hematology and BMT
Division_Hematology and BMT
No.8 P kalinga rao road
sampangiram road,
Bangalore-560027
Bangalore
KARNATAKA
560027
India |
| Phone |
9741351357 |
| Fax |
|
| Email |
drsachinjadhav@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Tower 1 OPD Room No-1
HCG Cancer Hospital
Department-Hematology and BMT
Division_Hematology and BMT
No.8 P kalinga rao road
sampangiram road,
Bangalore-560027 |
|
|
Primary Sponsor
|
| Name |
Dr Sachin Suresh Jadhav |
| Address |
Tower-1, OPD
HCG Cancer Hospital
No.8 P kalinga rao road
sampangiram nagar
bangalore-560027 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr J Goutham Kumar |
HCG cancer Hospital |
Tower 1 OPD Room No-1
HCG Cancer Hospital
Department-Hematology and BMT
Division_Hematology and BMT
No.8 P kalinga rao road
sampangiram road,
Bangalore-560027
Bangalore
KARNATAKA |
08122250791
gowtam.k90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hcg-central ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D758||Other specified diseases of bloodand blood-forming organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sitagliptin |
tablet sitagliptin 600mg twice a day per oral for 14 days |
| Comparator Agent |
Standard GVHD prophylaxis with out sitagliptin |
1 cyclophosphamide 50mg per kg once a day for two days intravenous or
2 Cyclosporine 2.5 mg per kg twice a day per oral 6 months
3 Antithymoglobulin 2.5 mg per kg once a day for one day intravenous
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
all patients undergoing an allogeneic HSCT in our Department |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of acute GVHD as per National Institutes of Health (NIH) consensus criteria |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Chronic GVHD at last follow-up
Relapse free survival at last follow-up
Overall survival at last follow-up
|
5 years |
|
|
Target Sample Size
|
Total Sample Size="398"
Sample Size from India="398"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
SS Farag, et al. Dipeptidyl Peptidase 4 Inhibition for Prophylaxis of Acute Graft-versus-Host Disease. NEJM. 2021;384:11-9.
MQ Salas, A Viswabandya, et al. Dual T-cell depletion with ATG and PTCy for peripheral blood reduced intensity conditioning allo-HSCT results in very low rates of GVHD. BMT. 2020 Sep;55(9):1773-1783.
AH Filipovich, et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report. TCT. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•Acute
graft-versus-host disease (GVHD) remains a major complication and cause of
death after allogeneic hematopoietic stem-cell transplantation (HSCT).With the use of ATG and ptCy the incidence of grade II-IV acute GVHD has been decreased to 20.1% and of chronic GVHD to of moderate/severe chronic GVHD at 1 year to 12.4%, A phase 2 trial, has shown the reduction of grade II-IV acute GVHD to 5% with the addition of sitagliptin in combination with tacrolimus and sirolimus for the prevention of acute GVHD after myeloablative allogeneic peripheral-blood stem-cell transplantation.
|