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CTRI Number  CTRI/2023/11/060233 [Registered on: 24/11/2023] Trial Registered Prospectively
Last Modified On: 01/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Check Safety and Efficacy Abatacept vs Low dose ATG in Stem cell transplant patients 
Scientific Title of Study   Open-labelled, Interventional, randomized, controlled trial of Abatacept vs. Low dose Rabbit ATG/ATLG used for prophylaxis of graft versus host disease (GVHD) with Post transplant cyclophosphamide and Tacrolimus based regimens for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) of Hematological malignancies (A2G) Trial  
Trial Acronym  NA 
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 BMT 
Affiliation  HCG Cancer Hospital 
Address  Tower-1-OPD Sampangiram nagar HCG Cancer Hospital, Bangalore
Tower-1-OPD Sampangiram nagar HCG Cancer Hospital, Bangalore
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 BMT 
Affiliation  HCG Cancer Hospital 
Address  Tower-1-OPD Sampangiram nagar HCG Cancer Hospital, Bangalore
Tower-1-OPD Sampangiram nagar HCG Cancer Hospital, Bangalore
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 BMT 
Affiliation  HCG Cancer Hospital 
Address  Tower-1-OPD Sampangiram nagar HCG Cancer Hospital, Bangalore
Tower-1-OPD Sampangiram nagar HCG Cancer Hospital, Bangalore
Bangalore
KARNATAKA
560027
India 
Phone  9741351357  
Fax    
Email  drsachinjadhav@hotmail.com  
 
Source of Monetary or Material Support  
No sponsor for this trial, watever patient is spending is for treatment, we are using the patient data from treatment they are taking The study will be conducted on Healthcare global enterprises ltd, Bangalore, India 
 
Primary Sponsor  
Name  No Sponsor 
Address  Not applicable 
Type of Sponsor  Other [No sponsor] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sachin Suresh Jadhav  HCG CANCER HOSPITAL  Dr Sachin Suresh Jadhav P kalingarao road sampangiram nagar Bangalore
Bangalore
KARNATAKA 
8122250791

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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D728||Other specified disorders of whiteblood cells,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Abatacept  Adding Abatacept will reduce GVHD in Stem cell transplant patients Abatacept 10 mg/kg will be given IV on days -1, + 5, + 14, + 28,  
Comparator Agent  Low dose ATG  Comparing with Abatacept to check incidence of GVHD ATLG (15mg/kg over 3 days on days -4, -3, and -2) 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion Criteria: All Patients who undergo HSCT for hematological malignancies.
All patients and/or their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Exclusion Criteria: Serious psychiatric disease including schizophrenia, bipolar disorder and severe depression.
Pregnancy (positive serum B-HCG) or breastfeeding.
Known hypersensitivity reactions to Abatacept/ATG
Method of randomization: simple (1:1)
Method of allocation concealment: none, since this is an open-labelled study
Expected date of first enrolment: 31st November 2023
Estimated duration of trial: 3 years
Sponsor: none (Investigator initialed trial)
 
 
ExclusionCriteria 
Details  Exclusion Criteria: Serious psychiatric disease including schizophrenia, bipolar disorder and severe depression.
Pregnancy (positive serum B-HCG) or breastfeeding.
Known hypersensitivity reactions to Abatacept/ATG
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence and severity of acute GVHD day +28, +60, +100, +180 and +365
Grade III-IV acute GVHD at day +28, +60, +100, +180 and +365
Incidence of steroid-refractory GVHD at day +28, +60, +100, +180 and +365
Incidence and severity of Chronic GVHD at day +100, +180 and +365
 
At Last follow up 
 
Secondary Outcome  
Outcome  TimePoints 
At the last follow-up
GRFS
Incidence of opportunistic infections, such as: cytomegalovirus (CMV) reactivation, reactivation of other viral infections (EBV, etc.), bacterial sepsis
Relapse of hematologic malignancies
 
Till Last follow up 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)
Modification(s)  
01/01/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

·        Graft-versus-host disease (GVHD) remains a challenge after allogeneic hematopoietic cell transplantation (HCT). GVHD occurs when immunocompetent donor T cells recognize the recipient host as foreign and mount an immune response to allogeneic antigen-bearing cells with subsequent destruction of host tissues.

·        Despite current prophylactic strategies, morbidity and mortality remain high, and treatment of established GVHD can be difficult, with only about 40% of patients having a durable response to corticosteroid therapy.

·        The most common GVHD prophylaxis has historically been based on a calcineurin inhibitor and a short course of methotrexate (MTX). MTX, an antimetabolite and folate antagonist, attenuates T-cell activation at low non-cytotoxic doses and has had a long history in the prevention of GVHD.

·        Abatacept and ATG has shown great promise in further reduction of acute and chronic GVHD. When ATG was added to the preparative regimen in an intention to treat analysis, the rate of II-IV aGVHD (40% with abatacept and 42% with ATG) was similar but grade III-IV aGVHD remained significantly higher (3% with abatacept and 22% with ATG)

·        Further, Abatacept did not increase relapse rates; 22% of abatacept-treated patients relapsed in the 8/8 cohort and 9% for the 7/8 cohort.

·        The addition of abatacept appeared safe with similar engraftment (100% 7/8) and leukocyte reconstitution compared to controls. No significant increase in CMV or EBV reactivation or end-organ disease was observed.

·        However, there is no study with direct comparison between ATG and Abatacept. 

 
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