Biobank of Acute Leukemia to study disease biology

Not yet recruiting

Conditions: Acute leukemia of unspecified celltype,

Registration Number: CTRI/2025/04/085648

Lead Sponsor: Indian Council of Medical Research (ICMR)

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 inthe Department of Medical Oncologyb) Either a diagnosis of ALL, AML, or APMLc) Patients who are treatment naïved) 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 680

Inclusion Criteria

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.

Exclusion Criteria

Exclusion criteria a) patients who refuse to give consent b) pregnant women with acute leukemia.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
🇮🇳
Pondicherry, PONDICHERRY, India
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
🇮🇳Pondicherry, PONDICHERRY, India
Dr Smita Kayal
Principal investigator
7598118439
kayalsmita@gmail.com