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

JRCT ID: jRCTs031180103

Registered date:04/02/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: DLBCL, including subtype; lymphomatoid granulomatosis(G3); primary mediastinal large B cell lymphoma
• Date of first enrollment: 01/09/2010
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Arm A:bi-R-CHOP+ PBSCT+ Involved-field radiotherapy (IFRT) 30-40 Gy
1) bi-R-CHOP X 6 courses
Rituximab 375 mg/m2 day 1
Cyclophosphamide750 mg/m2 day 1,
Doxorubicin 50 mg/m2 day 1,
Vincristine 1.4 mg/m2 day 1,
Prednisolone(PSL) 100 mg/body days 1 to 5
G-CSF day 8 to day13
2) PBSCT
melphalan 130 mg/ m2 day -1
Cyclophosphamide 60 mg/kgday -4, -3
mesna 72 mg/kgday -4, -3
etoposide500 mg/ m2 day -4 to -2
dexamethasone 40 mg/body day -4 to -1
PBSCT day 0
G-CSF day 1
3) Involved-field radiotherapy (IFRT) 30-40 G
Arm B: bi-R-CHOP+CHASER+PBSCT+Involved-field radiotherapy (IFRT) 30-40 Gy
1)bi-R-CHOP X 3 courses
Rituximab 375 mg/m2 day 1
Cyclophosphamide750 mg/m2 day 1,
Doxorubicin 50 mg/m2 day 1,
Vincristine 1.4 mg/m2 day 1,
Prednisolone(PSL) 100 mg/body days 1 to 5
G-CSF day 8 to day13
2) CHASER x 3 courses
Rituximab 375 mg/ m2 day 1
Cyclophosphamide1,200 mg/ m2 day 2
cytarabine 2,000 mg/ m2 day 3. 4
etoposide 100 mg/ m2 day 2. 3. 4
dexamethasone 40 mg/body day 2. 3, 4
G-CSF day 8
3) PBSCT
melphalan 130 mg/ m2 day -1
Cyclophosphamide 60 mg/kgday -4, -3
mesna 72 mg/kgday -4, -3
etoposide500 mg/ m2 day -4 to -2
dexamethasone 40 mg/body day -4 to -1
PBSCT day 0
G-CSF day 1
4) Involved-field radiotherapy (IFRT)30-40 G

Outcome(s)

• Primary Outcome: 2-year progression free survival rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: YAMAMOTO Kazuhito
• Source(s) of Monetary Support: National Cancer Center Japan,Ministry of Health, Labour and Welfare
• Secondary ID(s): UMIN000003823