EDOCH Alternating With DHAP for New Diagnosed Younger MCL

Phase 4

• Conditions: Mantle Cell Lymphoma
• Interventions: Drug: Etoposide; Drug: Cytarabine; Drug: Thalidomide; Drug: Doxorubicin; Drug: Dexamethasone; Drug: Cyclophosphamide; Drug: Prednisone; Drug: Cisplatin; Drug: Vincristine; Drug: Rituximab

• Registration Number: NCT02858804
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-07-17
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-08
• Last Update Submitted: 2019-06-13
• Last Update Posted: 2019-06-14
• Primary Completion: 2019-12
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• age≤65 years
• diagnosis with mantle cell lymphoma
• Ann Arbor stage II,III or IV
• ECOG≤1 or if ECOG≥2 but recover after pretreatment.

Exclusion Criteria

• with centre neural system involvement
• serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician
• HIV positive or active HBV infection or other uncontrolled systematic infection
• clinical central nervous dysfunction
• serious surgery within 30 days
• pregnancy or baby nursing period or un-contracepted child bearing period woman.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
progression free survival	up to 36 months	the time interval between diagnosis and disease progression or death or last follow-up

Secondary Outcome Measures

Name	Time	Method
overall survival	up to 36 months	time interval between diagnosis and death or last follow-up
complete remission	up to 6 months	measure with normal serum immunofixation electrophoresis and normal bone marrow feature, and without symptoms and enlarged organs

Trial Locations

Locations (1)

Shuhua Yi; 🇨🇳 Tianjin, China