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B-cell LymphomaNCT02354846

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 of B-cell Lymphoma, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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) Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
B-cell Lymphoma
How many people
112 participants
Where
1 siteSouth Korea
Study dates
Feb 2015to Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Do young Kim, MD contact

82-2-2228-1992

DYK1025@yuhs.ac

South Korea1 site, 1 recruiting

  • Severance Hospital

    Seoul, 120-752

    Do young Kim, MD, 82-2228-1992, DYK1025@yuhs.ac

    Do Young Kim, MD

    Recruiting

Other trials in South Korea

About this study

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
Medical subject headings
Lymphoma, B-Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years (every 3 months)

  2. Percentage number of patients with hepatitis due to Safety assessment

    Safety assessment; NCI CTCAE v 4.0 and tolerability evaluation - drug compliance

    Measured: 2 years (every 3 months)

  3. 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.

    Measured: 2 years (every 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionMar 2021 (estimated)
  4. Study completionMar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02354846
Sponsor's protocol ID
4-2014-0928
Status last verified
Jul 2018
First submitted
11 Jan 2015
Last updated
17 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim DY, Kim YR, Suh C, Yoon DH, Yang DH, Park Y, Eom HS, Lee JO, Kwak JY, Kang HJ, Hyun SY, Jo JC, Chang MH, Yoo KH, Lim SN, Shin HJ, Kim WS, Kim IH, Kim MK, Kim HJ, Lee WS, Mun YC, Kim JS. A Prospective Study of Preemptive Tenofovir Disoproxil Fumarate Therapy in HBsAg-Positive Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. Am J Gastroenterol. 2023 Aug 1;118(8):1373-1380. doi: 10.14309/ajg.0000000000002185. Epub 2023 Jan 13.

    PubMed 36728217

Questions about this trial

What is this clinical trial studying?

An observational study of B-cell Lymphoma, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Do young Kim, MD (82-2-2228-1992, DYK1025@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage number of patients with hepatitis due to HBV reactivation (time frame: 2 years (every 3 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02354846, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.

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