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CTRI Number  CTRI/2025/04/085648 [Registered on: 25/04/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Biobank of Acute Leukemia to study disease biology 
Scientific Title of Study   Biorepository of Acute Leukemia for Investigating the Biology of High Risk, Relapsed and Refractory Leukemias 
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 Smita Kayal 
Designation  Additional Professor & Head 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research 
Address  Department of Medical Oncology, Super specialty (SSB) Block (in patient wing, 3rd floor), JIPMER, Puducherry
JIPMER
Pondicherry
PONDICHERRY
605006
India 
Phone  7598118439  
Fax    
Email  kayalsmita@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smita Kayal 
Designation  Additional Professor & Head 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research 
Address  Department of Medical Oncology, Super specialty (SSB) Block (in patient wing, 3rd floor), JIPMER, Puducherry
JIPMER
Pondicherry
PONDICHERRY
605006
India 
Phone  7598118439  
Fax    
Email  kayalsmita@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Smita Kayal 
Designation  Additional Professor & Head 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research 
Address  Department of Medical Oncology, Super specialty (SSB) Block (in patient wing, 3rd floor), JIPMER, Puducherry
JIPMER
Pondicherry
PONDICHERRY
605006
India 
Phone  7598118439  
Fax    
Email  kayalsmita@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi, India 110029  
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, India 605006.  
 
Primary Sponsor  
Name  Indian Council of Medical Research (ICMR) 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Jawaharlal Institute of Postgraduate Medical Education Research JIPMER  Dhanvantri nagar, Puducherry 605006 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Smita Kayal  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)  Room No. 3, Department of Medical Oncology, Third floor, Superspeciality block, JIPMER Puducherry 605006
Pondicherry
PONDICHERRY 
7598118439

kayalsmita@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Observational Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C950||Acute leukemia of unspecified celltype,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion criteria
a) All newly diagnosed patients with acute leukemia who are registered in the Department of Medical Oncology
b) Either a diagnosis of ALL, AML, or APML
c) Patients who are treatment naive
d) All age groups and gender 
 
ExclusionCriteria 
Details  Exclusion criteria
a) patients who refuse to give consent
b) pregnant women with acute leukemia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Establish a biorepository for acute leukemia with well-annotated clinical data.   1. Baseline at diagnosis[T1]
2. At remission (21-28 days) [T2]
3. At treatment completion (if feasible)[T3]
4. At relapse (where applicable)[T4]
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Augment in-house laboratory capacity in leukemia-specific advanced investigations
2. Support the conduct of local need-based translational studies for high-risk and relapsed/refractory acute leukemia in the focused areas defined in the CAR project.
3. Provide a platform to conduct future studies investigating different biological and
clinical aspects of this rare but potentially curable malignancy and eventually become a resource for clinicians, and basic scientists. 
1. Baseline at diagnosis[T1]
2. At remission (21-28 days) [T2]
3. At treatment completion (if feasible)[T3]
4. At relapse (where applicable)[T4]
 
 
Target Sample Size   Total Sample Size="680"
Sample Size from India="680" 
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)   15/05/2025 
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="5"
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  
Background: Acute leukemia, such as acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), including its subtype acute promyelocytic leukemia (APML), is a rare and complex disease characterized by clonal hematopoiesis and rapid growth of immature white blood cells in peripheral blood (PB) and/or bone marrow (BM). It varies significantly between patients and differs at the epidemiologic, genetic, cellular, and microenvironment levels. While several advances have been made over the last decades in treatment, many of these cancers remain challenging to treat. In low-middle income settings, treatment outcomes of acute leukemia are characterized by a significantly high relapse rate (20 -30% in ALL and up to 50-60% for adult AML). The outcomes of relapsed leukemia are dismal due to poor disease biology, suboptimal efficacy of existing chemotherapy regimens, inadequate resources for BMT, and inaccessibility to newer therapies, thus necessitating translational research to understand the disease etiopathogenesis and develop innovative treatment approaches. 
Rationale: Establishing a leukemia biorepository and exploring novel risk factors in acute leukemia through integrated multi-omics and machine-learning approaches whichwill help achieve improved clinical risk stratification and identify potential targets for personalized therapeutic interventions.
Novelty: According to BBMRI-ERIC (Biobanking and BioMolecular Resources Research Infrastructure), out of 641 recorded biobanks, only seven collect biological resources from pediatric populations. Biobank of Leukemia (BioLa) will be a unique repository of Leukemias from pediatric to geriatric populations in India to facilitate research on high-risk (HR) and relapsed/refractory (R/R) leukemias.
Expected Outcome: Biorepositories are gaining importance for developing a sustainable impact on cancer research, generating a high-quality resource with clinical annotation of relevant biological samples. To overcome the lack of samples of proven quality for the study of leukemias, the Biobank of Leukemias (BioLa) can promote research to improve prevention, diagnosis, and therapy in the field of high-risk and refractory leukemias. Through BioLa, we expect to strengthen national and international scientific collaborations further.
Timeline of the study: 5 years
Key Inclusion criteria: a) All newly diagnosed patients with acute leukemia who are registered in the Department of Medical Oncology b) Either a diagnosis of ALL, AML, or APML c) Patients who are treatment naïve d) all age groups and gender
Purpose &Scope of the study:The proposed biobank aims to establish a repository of biospecimens from patients with newly diagnosed acute leukemia, along with well-annotated clinical data collected longitudinally, to elucidate the pathophysiology of the disease, especially to identify biomarkers.  Eventually, the biorepository will aid translational research in the development of new therapeutic approaches for the treatment of acute leukemia. This leukemia biorepository will obtain, store, and interrogate patient samples, including serum/plasma, leukemic blasts, and germline tissue, for further studies to identify and validate novel biomarkers and design clinical trials testing new therapeutic approaches for patients with acute leukemia as proposed in the overall CAR project. The biorepository would maintain a database of samples including clinical and biological characteristics. The CAR project committee would support the repository and review other future studies planned for the use of these banked leukemia samples. With these concerted efforts, we seek to provide benefits to future acute leukemia patients through the translation and application of our research findings.
 
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