RHCACD20MA (HS006) Combined With CHOP (Hi-CHOP) in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

May 12, 2016

Primary Completion Date

August 12, 2016

Study Completion Date

January 14, 2018

Conditions
Diffuse Large B-cell Lymphoma
Interventions
DRUG

HS006+CHOP

"Drug:HS006 HS006 375 mg per square meter (mg/m\^2),administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles.~Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle.~Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle.~Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle.~Drug: Prednisone Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle."

DRUG

HS006+CHOP

"Drug:HS006 HS006 500 mg per square meter (mg/m\^2),administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. During cycle 1,HS006 also infused on Day 8 and 15.~Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle.~Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle.~Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle.~Drug: Prednisone Prednisone 100 mg administered orally on Days 1-5 of each 21-day cycle."

DRUG

Rituximab+CHOP

"Drug:Rituxan Rituxan 375 mg per square metre (mg/m\^2), administered by intravenous (IV) on Day 1 of each 21-day cycle.~Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle.~Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle.~Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle.~Drug: Prednisone Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle."

All Listed Sponsors
lead

Zhejiang Hisun Pharmaceutical Co. Ltd.

INDUSTRY

NCT03485118 - RHCACD20MA (HS006) Combined With CHOP (Hi-CHOP) in Patients With Previously Untreated Diffuse Large B-cell Lymphoma | Biotech Hunter | Biotech Hunter