| CTRI Number |
CTRI/2025/10/095643 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in patients with acute lymphoblastic leukaemia to compare two ways of giving steroids during initial treatment, to see which is more effective and safer. |
|
Scientific Title of Study
|
Comparison of alternate-week versus continuous steroid therapy during induction in acute lymphoblastic leukemia: A study on efficacy and toxicity outcome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abirami |
| Designation |
Senior Resident |
| Affiliation |
All India institute of medical sciences, New Delhi |
| Address |
Department of Hematology, Room 205, New Private ward 2nd floor, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8939033321 |
| Fax |
|
| Email |
abbyselva7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukul Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
All India institute of medical sciences, New Delhi |
| Address |
Department of Hematology, Room 205, New Private ward 2nd floor, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8800898282 |
| Fax |
|
| Email |
mukulhemat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abirami |
| Designation |
Senior Resident |
| Affiliation |
All India institute of medical sciences, New Delhi |
| Address |
Department of Hematology, Room 205, New Private ward 2nd floor, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8939033321 |
| Fax |
|
| Email |
abbyselva7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Hematology, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 S Abirami |
All India Institute of Medical Sciences, New Delhi |
Department of Hematology, Room 205, New Private ward 2nd floor, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI |
8939033321
abbyselva7@gmail.com |
|
|
Details of Ethics Committee
|
|
|
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 |
Alternate week steroid therapy |
Prednisolone (steroid) will be given orally at 60mg/m2 alternate weekly during the 4 weeks of induction therapy in patients with acute lymphoblastic leukaemia |
| Comparator Agent |
Continuous steroid therapy |
Patients getting daily steroid therapy during induction for ALL will be compared with patients receiving alternate week steroid therapy. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed B-ALL and T-ALL
ECOG 0-2 and fit to start therapy |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the rate of complete
remission (CR), including measurable
residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus
continuous steroid therapy.
To assess the rate of early
mortality (induction deaths) in each
treatment group. |
To compare the rate of complete
remission (CR), including measurable
residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus
continuous steroid therapy.
To assess the rate of early
mortality (induction deaths) in each
treatment group.
Patients will be assessed at the end of induction (4 weeks). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of
induction-related infections (bacterial,
fungal, and viral), graded by CTCAE v5.0,
during the first 5 weeks of treatment
between the two steroid regimens. |
5 weeks |
To assess and compare the
frequency of steroid-related complications in both groups. |
End of induction |
To evaluate leukemia-free
survival and overall survival at 6 months
and 12 months in each group. |
6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a prospective, interventional study designed to compare alternate week versus continuous steroid therapy during induction in patients with acute lymphoblastic leukemia. Steroids are an essential component of induction chemotherapy but are associated with significant toxicity. The study aims to determine whether alternate week steroid administration provides similar efficacy with reduced toxicity compared to continuous steroid therapy. Patients will be randomized into two groups, one receiving continuous steroids and the other receiving alternate week steroids during induction. Outcomes assessed will include remission status, minimal residual disease, treatment related toxicities, and supportive care requirements. The results are expected to provide evidence for optimizing steroid scheduling to improve both safety and efficacy in the management of acute lymphoblastic leukemia.
|