| CTRI Number |
CTRI/2024/06/068451 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two ways of using medications for preventing graft versus host disease after a half-matched stem cell transplant |
|
Scientific Title of Study
|
A Phase II open-label, randomized controlled trial evaluating the effect of early versus conventional calcineurin inhibitor and mycophenolate mofetil initiation in graft-versus-host disease (GVHD) prophylaxis on the incidence of acute grade 2-4 GVHD in patients undergoing T cell replete haploidentical stem cell transplantation using post-transplant cyclophosphamide |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Uday Kulkarni |
| Designation |
Professor |
| Affiliation |
Christian Medical College Vellore, Ranipet Campus |
| Address |
Room 22, A501, 5th floor
Christian Medical College Vellore, Ranipet Campus
Vellore
TAMIL NADU
632517
India |
| Phone |
04172224553 |
| Fax |
04172224553 |
| Email |
kulkarni.uday@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Uday Kulkarni |
| Designation |
Professor |
| Affiliation |
Christian Medical College Vellore, Ranipet Campus |
| Address |
Room 22, A501, 5th floor
Christian Medical College Vellore, Ranipet Campus
Vellore
TAMIL NADU
632517
India |
| Phone |
04172224553 |
| Fax |
04172224553 |
| Email |
kulkarni.uday@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Uday Kulkarni |
| Designation |
Professor |
| Affiliation |
Christian Medical College Vellore, Ranipet Campus |
| Address |
Room 22, A501, 5th floor
Christian Medical College Vellore, Ranipet Campus
Vellore
TAMIL NADU
632517
India |
| Phone |
04172224553 |
| Fax |
04172224553 |
| Email |
kulkarni.uday@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 Uday Kulkarni |
Christian Medical College Vellore Ranipet Campus |
Department of Haematology, Christian Medical College Vellore, Ranipet Campus
Vellore
TAMIL NADU |
04172224553
04172224553
kulkarni.uday@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Offic of Research, Christian Medical College Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C920||Acute myeloblastic leukemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cyclosporine
Mycophenolic acid mofetil |
Cyclosporine 2.5mg/kg IV Q12H from day 0
Mycophenolic acid mofetil x 15mg per kg per dose x PO X TID with a maximum dose of 1g TID.
Duration of treatment For Malignant conditions: 3 to 6 months or as clinically indicated.
Duration of treatment For Non-Malignant conditions: Upto 1 year or as clinically indicated. |
| Comparator Agent |
Cyclosporine
Mycophenolic acid mofetil |
Cyclosporine and MMF from day +5
Cyclosporine 2.5mg/kg IV Q12H
Mycophenolic acid mofetil x 15mg per kg per dose x PO X TID with a maximum dose of 1g TID.
Duration of treatment For Malignant conditions: 3 to 6 months or as clinically indicated.
Duration of treatment For Non-Malignant conditions: Upto 1 year or as clinically indicated. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients planned for haploidentical stem cell transplantation using post-transplant cyclophosphamide |
|
| ExclusionCriteria |
| Details |
1. Patients planned for T cell depleted haplodentical stem cell transplantation
2. Patients with significant organ dysfunction (creatinine above 2mg%, liver enzymes above 5 times the upper limit of normal, LV ejection fraction less than 40%)
3. Patients with active infection at the time of transplant
4. Patients undergoing a second transplant
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Acute grade 2-4 graft versus host disease by day 100
Acute GVHD will be graded as per the modified Glucksberg criteria |
Day 100 assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cytokine release syndrome CRS within 14 days post-stem cell infusion, Time to engraftment, Graft failure, Chronic GVHD, 1 year overall survival and plasma GVHD biomarkers |
Day 30 post transplant |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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
|
After the institutional ethics
committee’s approval and clinical trial registration, we will begin enrollment.
After a written informed consent, 120 patients planned for haploidentical stem
cell transplantation at our center will be enrolled. Stratified randomization
(stratified for donor age above and below 30 years and by benign versus
malignant indication) will be performed using computer-generated sequences and
patients will be allocated to the following groups:
Group A: Cyclosporine from day 0 and mycophenolate mofetil from day 1
Group B: Cyclosporine and mycophenolate
mofetil from day +5
The initial dose of cyclosporine will be 2.5mg/kg IV Q12H.
Cyclosporine levels will be monitored and doses will be titrated as per levels
to achieve a trough level of 200 to 300 ng/ml for cyclosporine. Plasma samples
for GVHD biomarker analysis will be collected on day 14 and day 28 and stored.
The dose of mycophenolate mofetil (MMF) will be 15mg per kg
per dose PO TID with a maximum dose of 1g TID.
The primary outcome variable will be acute grade 2-4 GVHD
while the secondary outcome variables will be CRS, graft failure, time to
engraftment, chronic GVHD, 1 year overall survival, peak IL-6 levels, and plasma
GVHD biomarkers measured on day 14 and day 28.
|