Skip to content

An observational study to determine the risk of Hepatitis B reactivation in adolescent and adult acute lymphoblastic leukemia/lymphoblastic lymphoma (ALL/LbL) with hidden Hepatitis B infection (OHBI).

A prospective observational study to determine the risk of Hepatitis B viral reactivation in adolescent and adult acute lymphoblastic leukemia/lymphoblastic lymphoma (ALL/LbL) with Occult Hepatitis B infection (OHBI). - OHBI

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/01/007747
Enrollment
350
Registered
2017-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Adult acute lymphoblastic leukemia/Lymphoblastic lymphoma

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed Patients of Acute lymphoblastic leukemia/lymphoblastic lymphoma aged >= 15 years. 2. Treated on standard ALL protocol such as BFM 90 protocol. 3. Occult Hepatitis B infection. 4. Normal Liver function tests (AST/ALT 5. Those who give a written informed consent.

Exclusion criteria

Exclusion criteria: Patients with Hepatitis C viral co-infection. 2. Patients with Human immunodeficiency virus co-infection. 3. Patients with history of Hepatitis B vaccination (if anti HBs titre is >5U/L).

Design outcomes

Primary

MeasureTime frame
Risk of Hepatitis B reactivationTimepoint: At baseline, at the end of week 4, week 8, week 20, 32, week 48, at the completion of maintenance, post 6 months of completion of treatment

Secondary

MeasureTime frame
Correlation Between baseline HBV DNA and risk of HBV reactivationTimepoint: 2 years;Delay in administration of Myelosuppressive chemotherapyTimepoint: during intensive phase;Incidence of CMV ViremiaTimepoint: During Intensive Phase;Incidence of HBV related HepatitisTimepoint: Upto 2 years on treatment;Incidence of OHBITimepoint: at Baseline

Countries

India

Contacts

Public ContactDr Hasmukh Jain

Tata Memorial Hospital

dr.hkjain@gmail.com9167347482

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 8, 2026