NCT02858804

EDOCH Alternating With DHAP for New Diagnosed Younger MCL

EDOCH Alternating With DHAP Regimen Combined Rituximab or Not to Treat New Diagnosed Younger (Age≤65 Years) Mantle Cell Lymphoma in China: A Multicentre Phase III Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to: 1. determine the efficiency of EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) alternating with DHAP (cisplatin, cytarabine and dexamethasone) regimen combined with rituximab or not in young mantle cell lymphoma patients (age≤65 years); 2. determine the efficiency of rituximab and thalidomide plus prednisone as maintenance regimens.

Detailed description

Enrolled patients will receive EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) ±R /DHAP(cisplatin, cytarabine and dexamethasone) ±R alternating chemotherapy. If a partial remission or better response achieves, patients will be recommended to receive autologous stem cell transplantation as consideration therapy or another two cycles EDOCH ±R /DHAP±R chemotherapy (based on patient's choice). Patients with less than partial remission (PR) response will quit this study. After treatments finished, maintenance therapy with rituximab or thalidomide plus prednisone will be given less than two years. The determination of maintenance regimens is dependent on patients choices.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Etoposide	50 mg/m2, IV d1-4
DRUG	Doxorubicin	10 mg/m2, IV, d1-4
DRUG	Dexamethasone	30 mg/d, d1-5
DRUG	Vincristine	0.4 mg/m2, IV, d1-4
DRUG	Cyclophosphamide	750 mg/m2 ,d5
DRUG	Cytarabine	2g/m2, q12h, d1
DRUG	Cisplatin	100mg/ m2,IV, d1
DRUG	Rituximab	375 mg/m2 IV, d1
DRUG	Thalidomide	50-150mg/d, po, d1-28
DRUG	Prednisone	0.5mg/Kg, po, qod

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-12-01
• Completion: 2020-06-01
• First posted: 2016-08-08
• Last updated: 2026-02-11

Locations

1 site across 1 country: China