JCOG0908: Randomized phase II study of biweekly R-CHOP versus biweekly R-CHOP followed by CHASER as induction therapy for high-dose chemotherapy, LEED, and autologous stem-cell transplantation in poor-risk diffuse large B-cell lymphoma
- Conditions
- DLBCL, including subtypelymphomatoid granulomatosis(G3)primary mediastinal large B cell lymphoma
- Registration Number
- JPRN-jRCTs031180103
- Lead Sponsor
- YAMAMOTO Kazuhito
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
1) Histologically confirmed diffuse large B-cell lymphoma, including subtypes, lymphomatoid granulomatosis Grade 3, and primary mediastinal (thymic) large B-cell lymphoma (except for intravascular large B-cell lymphoma)
2) Positive for CD20 in lymphoma cells
3) Aged 20 to 65 years old
4) Performance status (PS) of 0-2 on ECOG(Eastern Cooperative Oncology Group) scale
5) Stage III or IV disease, or stage II with bulky disease
6) High-intermediate or high risk group on AA-IPI (Age-adjusted International Prognostic Index) score
7) Lymphoma cells in peripheral blood <=10,000/mm3
8) No testicular or central nervous system involvement
9) Having measurable lesions
10) No previous history of chemotherapy, radiation therapy, interferon and/or antibody
11) Adequate hematological and major organ function
12) Written informed consent
1) History of glaucoma
2) Diabetes mellitus regularly treated with insulin or uncontrollable diabetes mellitus
3) Uncontrollable hypertension
4) Serious cardiac conditions such as coronary disease, myocardiopathy and/or heart failure that requires treatment, and/or arrhythmia treated with antiarrhythmic
5) Positive test for HBs antigen
6) Positive test for HCV antibody
7) Positive test for HIV antibody
8) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema
9) Other active malignancies
10) Severe infection that requires systemic therapy
11) Fever above 38 degrees Celsius except related to B symptoms
12) Pregnant, possible pregnant, or breastfeeding woman
13) Psychological disease or condition that precludes participation in clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year progression free survival rate
- Secondary Outcome Measures
Name Time Method Overall response rate and complete response rate of both the entire treatment courses and the induction phases, 2-year and 5-year overall survival rate, 5-year progression free survival rate, adverse events, serious adverse events, and incidence rate of secondary malignancies