| CTRI Number |
CTRI/2025/01/079435 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
RETROSPECTIVE OBSERVATIONAL |
| Study Design |
Other |
|
Public Title of Study
|
Outcome of B lymphoblastic leukemia in children |
|
Scientific Title of Study
|
Correlation of adverse prognostic factors with survival outcomes in paediatric Precursor-B Lymphoblastic Leukemias: a single centre experience |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NEHA SINGH |
| Designation |
PROFESSOR ONCOPATHOLOGY AND INCHARGE HEMATOPATHOLOGY |
| Affiliation |
TATA MEMORIAL CENTRE |
| Address |
HEMATOPATHOGY SECOND FLOOR HOMI BHABHA CANCER HOSPITAL VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09953086323 |
| Fax |
|
| Email |
drnehasingh123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHABANA AZAD |
| Designation |
DM SR, ONCOPATHOLOGY |
| Affiliation |
TATA MEMORIAL CENTRE |
| Address |
HEMATOPATHOGY SECOND FLOOR HOMI BHABHA CANCER HOSPITAL VARANASI
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7359902902 |
| Fax |
|
| Email |
shabazad18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHABANA AZAD |
| Designation |
DM SR, ONCOPATHOLOGY |
| Affiliation |
TATA MEMORIAL CENTRE |
| Address |
HEMATOPATHOGY SECOND FLOOR HOMI BHABHA CANCER HOSPITAL VARANASI
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7359902902 |
| Fax |
|
| Email |
shabazad18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mo monetary support has been received for this retrospective observational study |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 NEHA SINGH |
HOMI BHABHA CANCER HOSPITAL VARANASI |
HEMATOPATHOGY SECOND FLOOR
Varanasi
UTTAR PRADESH |
09953086323
drnehasingh123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MPMMCC AND HBCH |
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
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed patients of pediatric BLBL enrolled between July 2020 to June2023 |
|
| ExclusionCriteria |
| Details |
Patients with relapsed disease or partially-treated from outside
Those who refuse to give consent for the study.
Those who were lost to follow-up without completing chemotherapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the prognostic factors in B-LBLs on the basis of age TLC baseline immunophenotype ploidy status genetic features and CNS disease and classify them into standard and high risk subtypes AND
To study their correlation with EOI MRD status and survival outcomes 3 year RFS and OS
|
MRD Day 28 and 72 of chemotherapy RFS 1 year RFS 3 year OS at last follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="1"
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
|
Successful
treatment of paediatric Precursor-B Lymphoblastic Leukemias (B-LBL) relies on
assigning patients to appropriate risk groups. Modern protocols use a
combination of age, white cell count (WCC), CNS involvement, immunophenotype,
genetics and treatment response to assign patients to different treatment
pathways which determines chemo-intensity, randomisations offered and
eligibility for transplant or CAR-T. The primary aim
of this retrospective observational study is to study the prognostic factors in
B-LBLs on the basis of age, TLC, baseline immunophenotype, ploidy status,
genetic features and CNS disease and classify them into standard and high risk
subtypes and to study their correlation with EOI MRD status and survival
outcomes (3 year-RFS and OS). This study will involve approximately 800 newly
diagnosed adult (<15 years) patients of B-LBL. This will help in understanding the prognostic impact
of the immunophenotypic patterns and the genetic profile of our BLBL patients,
and may guide in deciding the targeted chemotherapy in selected cases.
|