| CTRI Number |
CTRI/2022/01/039113 [Registered on: 04/01/2022] Trial Registered Prospectively |
| Last Modified On: |
08/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of different steroids in ALL cancer patients |
|
Scientific Title of Study
|
Randomized controlled study to evaluate efficacy of dexamethasone versus prednisolone in induction phase in pediatric and adolescent acute lymphoblastic leukemia with respect to day 33 bone marrow minimal residual disease response |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karthik Kumar |
| Designation |
Senior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH |
| Address |
Department of Clinical Hematology All India Institute of Sciences Rishikesh Uttarakhand
Hostel no 84 AIIMS Rishikesh campus Veerbhadra road Rishikesh Uttarakhand
Dehradun
UTTARANCHAL
249 203
India |
| Phone |
9597675433 |
| Fax |
|
| Email |
drkarthikkumar92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uttam Kumar Nath |
| Designation |
Additional Professor & HOD |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH |
| Address |
Department of Clinical Hematology All India Institute of Sciences Rishikesh Uttarakhand
Hostel no 84 AIIMS Rishikesh campus Veerbhadra road Rishikesh Uttarakhand
Dehradun
UTTARANCHAL
249 203
India |
| Phone |
9433982756 |
| Fax |
|
| Email |
uttam.haemat@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karthik Kumar |
| Designation |
Senior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH |
| Address |
Department of Clinical Hematology All India Institute of Sciences Rishikesh Uttarakhand
Hostel no 84 AIIMS Rishikesh campus Veerbhadra road Rishikesh Uttarakhand
Dehradun
UTTARANCHAL
249 203
India |
| Phone |
9597675433 |
| Fax |
|
| Email |
drkarthikkumar92@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Rishikesh |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
All India Institute of Medical Sciences Rishikesh Veerbhadra road marg Rishikesh Uttarakhand |
| Type of Sponsor |
Government medical college |
|
|
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 Karthik Kumar |
AIIMS Rishikesh |
Department of Clinical Hematology All India Institute of Medical Sciences veerbhadra road marg Rishikesh
Dehradun
UTTARANCHAL |
9597675433
drkarthikkumar92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethosone |
Dexamethasone 10 mg/m2/day intravenously x 14 days (days 1-14) followed by tapering over next 7 days |
| Comparator Agent |
Prednisolone |
Prednisolone 60 mg/m2/day orally x 28 days (days 1-28) followed by tapering over next 7 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed patients of acute lymphoblastic leukemia (both B-ALL & T-ALL), between 1 year to 24 years of age, of any gender, where informed consent of parent/guardian is available |
|
| ExclusionCriteria |
| Details |
1.Infantile acute lymphoblastic leukemia (age < 1 year).
2.Patients of lymphoblastic lymphoma (LBL).
3.Relapsed cases of acute lymphoblastic leukemia.
4.Patients who have received dexamethasone, prednisolone or any other chemotherapy within 4 weeks of enrollment in study
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare bone marrow minimal residual disease (MRD) response by flowcytometry on day 33 of induction phase chemotherapy in the dexamethasone and prednisolone treatment groups |
0 days and 33 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Day 33 bone marrow morphological response in the two treatment groups.
2. To compare Day 15 bone marrow morphological response & MRD status in the two treatment groups as per protocol.
3. To compare the toxicity profile in the two treatment groups – adverse events of any grade, and adverse events of grade 3-4 (CTCAE- Common Terminology Criteria For Adverse Events Version 5).
|
0 days and 33 days |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2022 |
| Date of Study Completion (India) |
31/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drkarthikkumar92@gmail.com].
- For how long will this data be available start date provided 01-11-2022 and end date provided 01-11-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The proposed study will compare the efficacy of
dexamethasone versus prednisolone on treatment outcomes with respect to Day 33 Minimal
Residual Disease during induction phase chemotherapy in pediatric ALL at AIIMS
Rishikesh, in view of no published data on this theme in Indian pediatric ALL
patients |