EDOCH Alternating With DHAP for New Diagnosed Younger MCL

Mantle Cell Lymphoma Clinical Trial

— BDH-MCL01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02858804
• Other study ID #: IIT2015007-EC-1
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: June 2020

Study information

• Verified date: August 2016
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Shuhua Yi, Doc
• Phone: 86-22-23909106
• Email: yishuhua[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Shuhua Yi	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	the time interval between diagnosis and disease progression or death or last follow-up	up to 36 months
Secondary	complete remission	measure with normal serum immunofixation electrophoresis and normal bone marrow feature, and without symptoms and enlarged organs	up to 6 months
Secondary	overall survival	time interval between diagnosis and death or last follow-up	up to 36 months