BDH-MCL01: EDOCH Alternating With DHAP for New Diagnosed Younger MCL

Sponsor

Institute of Hematology & Blood Diseases Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02858804

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to:

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);
determine the efficiency of rituximab and thalidomide plus prednisone as maintenance regimens.

Condition or Disease	Intervention/Treatment	Phase
Mantle Cell Lymphoma	Drug: Etoposide Drug: Doxorubicin Drug: Dexamethasone Drug: Vincristine Drug: Cyclophosphamide Drug: Cytarabine Drug: Cisplatin Drug: Rituximab Drug: Thalidomide Drug: Prednisone	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Etoposide 50 mg/m2, IV, d1-4	Drug: Etoposide 50 mg/m2, IV d1-4 Other Names: VP-16
Experimental: Doxorubicin 10 mg/m2, IV, d1-4	Drug: Doxorubicin 10 mg/m2, IV, d1-4 Other Names: adriamycin
Experimental: Dexamethasone 30 mg/d, d1-5	Drug: Dexamethasone 30 mg/d, d1-5 Other Names: Dex
Experimental: Vincristine 0.4 mg/m2, IV, d1-4	Drug: Vincristine 0.4 mg/m2, IV, d1-4 Other Names: VCR
Experimental: Cyclophosphamide 750 mg/m2 ,d5	Drug: Cyclophosphamide 750 mg/m2 ,d5 Other Names: CTX
Experimental: Cytarabine 2g/m2, q12h, d1	Drug: Cytarabine 2g/m2, q12h, d1 Other Names: Ara-c
Experimental: Cisplatin 100mg/ m2,IV, d1	Drug: Cisplatin 100mg/ m2,IV, d1 Other Names: DDP
Experimental: Rituximab 375 mg/m2 IV, d1	Drug: Rituximab 375 mg/m2 IV, d1 Other Names: R
Experimental: Thalidomide 50-150mg/d, po, d1-28	Drug: Thalidomide 50-150mg/d, po, d1-28 Other Names: Thal
Experimental: Prednisone 0.5mg/Kg, po, qod	Drug: Prednisone 0.5mg/Kg, po, qod Other Names: Pred

Outcome Measures

Primary Outcome Measures

progression free survival [up to 36 months]
the time interval between diagnosis and disease progression or death or last follow-up

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.