EDOCH Alternating With DHAP for New Diagnosed Younger MCL
NCT ID: NCT02858804
Last Updated: 2019-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
55 participants
INTERVENTIONAL
2016-01-31
2020-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Etoposide
50 mg/m2, IV, d1-4
Etoposide
50 mg/m2, IV d1-4
Doxorubicin
10 mg/m2, IV, d1-4
Doxorubicin
10 mg/m2, IV, d1-4
Dexamethasone
30 mg/d, d1-5
Dexamethasone
30 mg/d, d1-5
Vincristine
0.4 mg/m2, IV, d1-4
Vincristine
0.4 mg/m2, IV, d1-4
Cyclophosphamide
750 mg/m2 ,d5
Cyclophosphamide
750 mg/m2 ,d5
Cytarabine
2g/m2, q12h, d1
Cytarabine
2g/m2, q12h, d1
Cisplatin
100mg/ m2,IV, d1
Cisplatin
100mg/ m2,IV, d1
Rituximab
375 mg/m2 IV, d1
Rituximab
375 mg/m2 IV, d1
Thalidomide
50-150mg/d, po, d1-28
Thalidomide
50-150mg/d, po, d1-28
Prednisone
0.5mg/Kg, po, qod
Prednisone
0.5mg/Kg, po, qod
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosis with mantle cell lymphoma
* Ann Arbor stage II,III or IV
* ECOG≤1 or if ECOG≥2 but recover after pretreatment.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Yi Shuhua
Principal Investigator
Principal Investigators
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Shuhua Yi, Doc
Role: PRINCIPAL_INVESTIGATOR
Blood disease hospital, Chinese Academic Medical School
Locations
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Shuhua Yi
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT2015007-EC-1
Identifier Type: -
Identifier Source: org_study_id
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