NCT00262210

Brief Summary

\* AIMS OF THE STUDY

  1. 1.To test if steroid-free chemotherapeutic regimens decrease the risk of HBV reactivation and hepatitis development in HBsAg (+) carriers.
  2. 2.To compare the efficacy of steroid-free chemotherapeutic regimens with that of steroid-containing regimens in terms of lymphoma control.
  3. 3.To study the change of activity of HBV and other hepatotropic viruses during the course of chemotherapy.

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 Jun 1995

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

June 1, 1995

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1999

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
Last Updated

December 6, 2005

Status Verified

December 1, 2005

First QC Date

December 5, 2005

Last Update Submit

December 5, 2005

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • We expect to enter 25 patients per year and finish accrual of patients within 4 years.

Interventions

Cyclophosphamide Epirubicin Etoposide PrednisoloneDRUG

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 evaluable disease
  • Signed informed consent

You may not qualify if:

  • Age \> 75 years, or Age \< 15 years
  • 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 ≧ GrII.
  • Concurrent glucocorticoids use (for other reasons). The conventional use of glucocorticoids for antiemetic purpose is also not allowed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University 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

  • Ann-Lii Cheng, Ph.D.

    Lymphoma Disease Committee of TCOG

    PRINCIPAL INVESTIGATOR

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

December 5, 2005

First Posted

December 6, 2005

Study Start

June 1, 1995

Study Completion

December 1, 1999

Last Updated

December 6, 2005

Record last verified: 2005-12

Locations

TW(1)