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

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ClinicalTrials.gov Identifier: NCT02858804
Recruitment Status : Recruiting
First Posted : August 8, 2016
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Yi Shuhua, Institute of Hematology & Blood Diseases Hospital

Brief Summary:

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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Etoposide
50 mg/m2, IV, d1-4
Drug: Etoposide
50 mg/m2, IV d1-4
Other Name: VP-16

Experimental: Doxorubicin
10 mg/m2, IV, d1-4
Drug: Doxorubicin
10 mg/m2, IV, d1-4
Other Name: adriamycin

Experimental: Dexamethasone
30 mg/d, d1-5
Drug: Dexamethasone
30 mg/d, d1-5
Other Name: Dex

Experimental: Vincristine
0.4 mg/m2, IV, d1-4
Drug: Vincristine
0.4 mg/m2, IV, d1-4
Other Name: VCR

Experimental: Cyclophosphamide
750 mg/m2 ,d5
Drug: Cyclophosphamide
750 mg/m2 ,d5
Other Name: CTX

Experimental: Cytarabine
2g/m2, q12h, d1
Drug: Cytarabine
2g/m2, q12h, d1
Other Name: Ara-c

Experimental: Cisplatin
100mg/ m2,IV, d1
Drug: Cisplatin
100mg/ m2,IV, d1
Other Name: DDP

Experimental: Rituximab
375 mg/m2 IV, d1
Drug: Rituximab
375 mg/m2 IV, d1
Other Name: R

Experimental: Thalidomide
50-150mg/d, po, d1-28
Drug: Thalidomide
50-150mg/d, po, d1-28
Other Name: Thal

Experimental: Prednisone
0.5mg/Kg, po, qod
Drug: Prednisone
0.5mg/Kg, po, qod
Other Name: Pred




Primary Outcome Measures :
  1. progression free survival [ Time Frame: up to 36 months ]
    the time interval between diagnosis and disease progression or death or last follow-up


Secondary Outcome Measures :
  1. complete remission [ Time Frame: up to 6 months ]
    measure with normal serum immunofixation electrophoresis and normal bone marrow feature, and without symptoms and enlarged organs

  2. overall survival [ Time Frame: up to 36 months ]
    time interval between diagnosis and death or last follow-up



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858804


Contacts
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Contact: Shuhua Yi, Doc 86-22-23909106 yishuhua@ihcams.ac.cn
Contact: Lugui Qiu, Doc 86-22-23909172 qiulg@ihcams.ac.cn

Locations
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China
Shuhua Yi Recruiting
Tianjin, China, 300020
Contact: Shuhua Yi, Doc    86-22-23909106    yishuhua@ihcams.ac.cn   
Contact: Lugui Qiu, Doc    86-22-23909172    qiulg@ihcams.ac.cn   
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
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Principal Investigator: Shuhua Yi, Doc Blood disease hospital, Chinese Academic Medical School

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Responsible Party: Yi Shuhua, Principal Investigator, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT02858804     History of Changes
Other Study ID Numbers: IIT2015007-EC-1
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yi Shuhua, Institute of Hematology & Blood Diseases Hospital:
mantle cell lymphoma
EDOCH
DHAP
maintenance therapy
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cytarabine
Thalidomide
Dexamethasone
Dexamethasone acetate
Prednisone
Cisplatin
Cyclophosphamide
Rituximab
Doxorubicin
Liposomal doxorubicin
Etoposide
Etoposide phosphate
Vincristine
BB 1101
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents