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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Unknown; Phase 4

Conditions: Mantle Cell Lymphoma

Treatments: Drug: Vincristine; Drug: Doxorubicin; Drug: Prednisone; Drug: Thalidomide; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Cisplatin; Drug: Cytarabine; Drug: Dexamethasone; Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT02858804

IIT2015007-EC-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 10 patient groups

Etoposide

Experimental group

Description:

50 mg/m2, IV, d1-4

Treatment:

Drug: Etoposide

Doxorubicin

Experimental group

Description:

10 mg/m2, IV, d1-4

Treatment:

Drug: Doxorubicin

Dexamethasone

Experimental group

Description:

30 mg/d, d1-5

Treatment:

Drug: Dexamethasone

Vincristine

Experimental group

Description:

0.4 mg/m2, IV, d1-4

Treatment:

Drug: Vincristine

Cyclophosphamide

Experimental group

Description:

750 mg/m2 ,d5

Treatment:

Drug: Cyclophosphamide

Cytarabine

Experimental group

Description:

2g/m2, q12h, d1

Treatment:

Drug: Cytarabine

Cisplatin

Experimental group

Description:

100mg/ m2,IV, d1

Treatment:

Drug: Cisplatin

Rituximab

Experimental group

Description:

375 mg/m2 IV, d1

Treatment:

Drug: Rituximab

Thalidomide

Experimental group

Description:

50-150mg/d, po, d1-28

Treatment:

Drug: Thalidomide

Prednisone

Experimental group

Description:

0.5mg/Kg, po, qod

Treatment:

Drug: Prednisone