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)

B-cell Lymphoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02354846
• Other study ID #: 4-2014-0928
• Status: Recruiting
• Start date: February 2015
• Est. completion date: March 2021

Study information

• Verified date: July 2018
• Source: Yonsei University
• Contact: Do young Kim, MD
• Phone: 82-2-2228-1992
• Email: DYK1025[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage number of patients with hepatitis due to HBV reactivation	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.	2 years (every 3 months)
Primary	Percentage number of patients with hepatitis due to Safety assessment	Safety assessment; NCI CTCAE v 4.0 and tolerability evaluation - drug compliance	2 years (every 3 months)
Primary	Chemotherapy disruption due to hepatitis	Chemotherapy disruption due to hepatitis: defined as either premature termination or delay of more than 8 days between chemotherapy cycles.	2 years (every 3 months)