Retrospective observational study for the risk of hepatitis B virus reactivation in patients with T-cell lymphoma who received mogamulizumab-containing chemotherapy

Retrospective observational study for the risk of hepatitis B virus reactivation in patients with T-cell lymphoma who received mogamulizumab-containing chemotherapy - PROACTIVE-MOGA study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048047

Enrollment

200

Registered

2022-06-17

Start date

2022-06-17

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

T-cell lymphoma patients with HBsAg-positive or resolved HBV infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with T-cell lymphoma histologically diagnosed including adult T-cell leukemia-lymphoma or cutaneous T-cell lymphoma 2) Patients with seropositive for HBsAg or resolved HBV infection (defined as HBsAg-negative but seropositive for anti-HBc or anti-HBs). Patients with seronegative for HBsAg and anti-HBc but seropositive for anti-HBs were excluded if he/she had a history of HB vaccination. 3) Patients who received mogamulizumab-containing chemotherapy 4) Patients who underwent HBV DNA monitoring (defined as at least one measurement of HBV DNA level after starting of mogamulizumab) 5) Patients older than age 20 years

Exclusion criteria

Exclusion criteria: 1) Patients with seropositive for anti-HCV. Patients without measurement for ant-HCV were eligible. 2) Patients with seropositive for anti-HIV. Patients without measurement for ant-HIV were eligible.

Design outcomes

Primary

Measure	Time frame
Incidence of HBV reactivation	—

Secondary

Measure	Time frame
Incidence of hepatitis and severity of hepatitis (requiring systemic steroids) Incidence of HBV reactivation-related hepatitis Incidence of HBV reactivation-related fulminant hepatitis Incidence of HBV reactivation-related mortality Incidence of decompensated liver cirrhosis (if patients with HBsAg-positive) Incidence of hepatocellular carcinoma (if patients with HBsAg-positive) Incidence of hepatocellular carcinoma-related mortality (if patients with HBsAg-positive) Incidence of anti-HBV prophylaxis using nucleoside/nucleotide analogues (if patients with HBsAg-positive) Incidence of anti-HBV treatment using nucleoside/nucleotide analogues (if patients with resolved HBV infection) Overall survival	—

Measure

Time frame

Incidence of hepatitis and severity of hepatitis (requiring systemic steroids) Incidence of HBV reactivation-related hepatitis Incidence of HBV reactivation-related fulminant hepatitis Incidence of HBV reactivation-related mortality Incidence of decompensated liver cirrhosis (if patients with HBsAg-positive) Incidence of hepatocellular carcinoma (if patients with HBsAg-positive) Incidence of hepatocellular carcinoma-related mortality (if patients with HBsAg-positive) Incidence of anti-HBV prophylaxis using nucleoside/nucleotide analogues (if patients with HBsAg-positive) Incidence of anti-HBV treatment using nucleoside/nucleotide analogues (if patients with resolved HBV infection) Overall survival

—

Countries

Japan

Contacts

Public ContactKisato Nosaka

Kumamoto University Hospital Cancer Center

knosaka@kumamoto-u.ac.jp096-373-5156

Outcome results