NCT00201318

Brief Summary

\* AIMS OF THE STUDY (STUDY OBJECTIVES)

  1. 1.To test the effect of daily lamivudine (100 mg) in reducing the risk of HBV reactivation and hepatitis development in HBsAg (+) NHL patients.
  2. 2.To test the efficacy of daily lamivudine in preventing and treating hepatitis B reactivation and in circumventing hepatic failure and death.
  3. 3.To test whether lamivudine can improve the overall outcome of NHL patients who are HBV carriers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

September 20, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 13, 2005

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • We expect to enter 33 patients per year. Taking into account 10﹪dropout rate, we may finish accrual of patients within 3 years.

Interventions

Cyclophosphamide Doxorubicin Vincristine LamivudineDRUG

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven NHL, and for which intensive chemotherapy is considered treatment-of-choice.
  • HBsAg-positive.
  • No previous chemotherapy and radiotherapy, no concurrent radiotherapy.
  • AGC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood.
  • Total bilirubin \< 2.5 mg/dl. Alanine aminotransferase (SGPT) \< 200 I.U./L
  • Serum creatinine ≦1.5 mg/dl Blood urea nitrogen (BUN) ≦ 25 mg/dl
  • Objectively measurable or valuable disease
  • Signed informed consent

You may not qualify if:

  • Age \> 75 years old, or Age \< 15 years old
  • Pregnant or breast-feeding women.
  • Patients with history of brain metastasis or CNS involvement.
  • Child's class B or C in patients with liver cirrhosis.
  • Impaired cardiac function with NYHA (New York Heart Association) classification ≧ Gr II.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Pei-Jer Chen, Ph.D.

    National Taiwan University Hospital

    STUDY CHAIR

  • Ann-Lii Cheng, Ph.D.

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 1, 2001

Study Completion

October 1, 2005

Last Updated

September 20, 2005

Record last verified: 2005-09

Locations

TW(1)