| 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
|
|
|
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
|
|
|
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. |