Status unknownNCT02354846Updated Jul 17, 2018

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)

An observational study in B-cell Lymphoma, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-07-17.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 112
Ages: 19 Years and older
Sex: All

Study 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)

Conditions studied

B-cell Lymphoma

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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 112 is below the median of 136 across 625 observational studies indexed under Lymphoma.

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Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Previously untreated Diffuse Large B-cell Lymphoma (DLBCL) with HBsAg (+) who are suitable for receiving R-CHOP chemotherapy

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

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 112 participants (estimated)
Patient registry: No

What researchers measure

Primary outcomes

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.
Time frame: 2 years (every 3 months)
Percentage number of patients with hepatitis due to Safety assessment
Safety assessment; NCI CTCAE v 4.0 and tolerability evaluation - drug compliance
Time frame: 2 years (every 3 months)
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.
Time frame: 2 years (every 3 months)

Study locations

1 of 1 sites recruiting

Severance Hospital
Seoul, 120-752, Korea, Republic of
- Do young Kim, MD · Contact · DYK1025@yuhs.ac · 82-2228-1992
- Do Young Kim, MD · Sub investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02354846
Lead sponsor: Yonsei University
Responsible party: Sponsor
First posted: Feb 3, 2015
Start date: Feb 2015
Primary completion: Mar 2021 (estimated)
Completion: Mar 2021 (estimated)
Last update: Jul 17, 2018

Study contacts

Do young Kim, MD

Contact

DYK1025@yuhs.ac

82-2-2228-1992

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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