Shuhua Yi
Tianjin, 300020, China
NCT Number: NCT02858804
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Tianjin, 300020, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50 mg/m2, IV d1-4
Other names: VP-16
10 mg/m2, IV, d1-4
Other names: adriamycin
30 mg/d, d1-5
Other names: Dex
0.4 mg/m2, IV, d1-4
Other names: VCR
750 mg/m2 ,d5
Other names: CTX
2g/m2, q12h, d1
Other names: Ara-c
100mg/ m2,IV, d1
Other names: DDP
375 mg/m2 IV, d1
Other names: R
50-150mg/d, po, d1-28
Other names: Thal
0.5mg/Kg, po, qod
Other names: Pred
Time frame: up to 36 months
the time interval between diagnosis and disease progression or death or last follow-up
Time frame: up to 6 months
measure with normal serum immunofixation electrophoresis and normal bone marrow feature, and without symptoms and enlarged organs
Time frame: up to 36 months
time interval between diagnosis and death or last follow-up
Institute of Hematology & Blood Diseases Hospital, China
Other
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
Acronym: BDH-MCL01
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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