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
|
|
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. |