An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy With Tenofovir in HBsAg-positive Patients With Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED Study)

• Conditions: B-cell Lymphoma

• Registration Number: NCT02354846
• Lead Sponsor: Yonsei University

Brief Summary

An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy with Tenofovir in HBsAg-positive Patients with Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED study)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-11
• Study First Submitted QC: 2015-01-29
• Study Start: 2015-02
• Study First Posted: 2015-02-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-15
• Last Update Posted: 2018-07-17
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Males or females aged more than18
• HBsAg-positive DLBCL patients (it is possible to enrol the patients with combined DLBCL and low grade lymphoma such as follicular lymphoma)
• Previously untreated DLBCL patients who are suitable for receiving R-CHOP chemotherapy
• Serum ALT no more than 2 x ULN (including normal ALT)
• Life expectancy 6 months
• A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are no more than 1 years after the onset of menopause.
• Informed consent

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Exclusion Criteria

• Other subtype of lymphoma except DLBCL
• DLBCL patients who are NOT suitable for receiving R-CHOP chemotherapy OR plan to receive other chemotherapy
• patients had been treated with antiviral therapy known to have activity against HBV (e.g., alpha-interferon, lamivudine, telbivudine, clevudine, adefovir, entecavir or tenofovir) within the previous 6 months.
• evidence of hepatocellular carcinoma.
• evidence of decompensated liver disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage number of patients with hepatitis due to HBV reactivation	2 years (every 3 months)	Percentage number of patients with hepatitis due to HBV reactivation during the preemptive tenofovir therapy and for 24 weeks after withdrawal from tenofovir.; Definition; * Hepatitis was defined as a more than 3-fold increase of serum ALT on 2 consecutive determinations at least 5 days apart.; * Hepatitis was defined to be due to HBV reactivation when it was preceded or accompanied by an increase of serum HBV DNA to more than 10 times that of the pre-exacerbation baseline and the serum HBV DNA turned from negative to positive.
Percentage number of patients with hepatitis due to Safety assessment	2 years (every 3 months)	Safety assessment; NCI CTCAE v 4.0 and tolerability evaluation - drug compliance
Chemotherapy disruption due to hepatitis	2 years (every 3 months)	Chemotherapy disruption due to hepatitis: defined as either premature termination or delay of more than 8 days between chemotherapy cycles.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of