Clinical trial · Observational
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)
NCT02354846CI-TRIAL-00033786unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Percentage number of patients with hepatitis due to HBV reactivation
- timeFrame
- 2 years (every 3 months)
- description
- 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.
- measure
- Percentage number of patients with hepatitis due to Safety assessment
- timeFrame
- 2 years (every 3 months)
- description
- Safety assessment; NCI CTCAE v 4.0 and tolerability evaluation - drug compliance
- measure
- Chemotherapy disruption due to hepatitis
- timeFrame
- 2 years (every 3 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKim 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. PMID 36728217