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)

Sponsor

Yonsei University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02354846

Collaborator

(none)

112

Enrollment

Location

72.9

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
B-cell Lymphoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

112 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Actual Study Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT02354846

Other Study ID Numbers:

4-2014-0928

First Posted:

Feb 3, 2015

Last Update Posted:

Jul 17, 2018

Last Verified:

Jul 1, 2018

Additional relevant MeSH terms:

Lymphoma

Lymphoma, B-Cell

Study Results

No Results Posted as of Jul 17, 2018