EDOCH Alternating With DHAP for New Diagnosed Younger MCL

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT02858804
Phase
PHASE4
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 31, 2016
Status verified
May 2024
Primary completion
Dec 31, 2019
Completion
Jun 30, 2020

Study Design

Enrollment
55 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

progression free survival [ Time Frame: up to 36 months ]

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