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

Primary Purpose

Mantle Cell Lymphoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Etoposide
Doxorubicin
Dexamethasone
Vincristine
Cyclophosphamide
Cytarabine
Cisplatin
Rituximab
Thalidomide
Prednisone
Sponsored by
Institute of Hematology & Blood Diseases Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring mantle cell lymphoma, EDOCH, DHAP, maintenance therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shuhua YiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Etoposide

Doxorubicin

Dexamethasone

Vincristine

Cyclophosphamide

Cytarabine

Cisplatin

Rituximab

Thalidomide

Prednisone

Arm Description

50 mg/m2, IV, d1-4

10 mg/m2, IV, d1-4

30 mg/d, d1-5

0.4 mg/m2, IV, d1-4

750 mg/m2 ,d5

2g/m2, q12h, d1

100mg/ m2,IV, d1

375 mg/m2 IV, d1

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

0.5mg/Kg, po, qod

Outcomes

Primary Outcome Measures

progression free survival
the time interval between diagnosis and disease progression or death or last follow-up

Secondary Outcome Measures

complete remission
measure with normal serum immunofixation electrophoresis and normal bone marrow feature, and without symptoms and enlarged organs
overall survival
time interval between diagnosis and death or last follow-up

Full Information

First Posted
July 17, 2016
Last Updated
June 13, 2019
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02858804
Brief Title
EDOCH Alternating With DHAP for New Diagnosed Younger MCL
Acronym
BDH-MCL01
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to: 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); determine the efficiency of rituximab and thalidomide plus prednisone as maintenance regimens.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma
Keywords
mantle cell lymphoma, EDOCH, DHAP, maintenance therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Etoposide
Arm Type
Experimental
Arm Description
50 mg/m2, IV, d1-4
Arm Title
Doxorubicin
Arm Type
Experimental
Arm Description
10 mg/m2, IV, d1-4
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
30 mg/d, d1-5
Arm Title
Vincristine
Arm Type
Experimental
Arm Description
0.4 mg/m2, IV, d1-4
Arm Title
Cyclophosphamide
Arm Type
Experimental
Arm Description
750 mg/m2 ,d5
Arm Title
Cytarabine
Arm Type
Experimental
Arm Description
2g/m2, q12h, d1
Arm Title
Cisplatin
Arm Type
Experimental
Arm Description
100mg/ m2,IV, d1
Arm Title
Rituximab
Arm Type
Experimental
Arm Description
375 mg/m2 IV, d1
Arm Title
Thalidomide
Arm Type
Experimental
Arm Description
50-150mg/d, po, d1-28
Arm Title
Prednisone
Arm Type
Experimental
Arm Description
0.5mg/Kg, po, qod
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VP-16
Intervention Description
50 mg/m2, IV d1-4
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
adriamycin
Intervention Description
10 mg/m2, IV, d1-4
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dex
Intervention Description
30 mg/d, d1-5
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
VCR
Intervention Description
0.4 mg/m2, IV, d1-4
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
CTX
Intervention Description
750 mg/m2 ,d5
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Ara-c
Intervention Description
2g/m2, q12h, d1
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
DDP
Intervention Description
100mg/ m2,IV, d1
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
R
Intervention Description
375 mg/m2 IV, d1
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Thal
Intervention Description
50-150mg/d, po, d1-28
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Pred
Intervention Description
0.5mg/Kg, po, qod
Primary Outcome Measure Information:
Title
progression free survival
Description
the time interval between diagnosis and disease progression or death or last follow-up
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
complete remission
Description
measure with normal serum immunofixation electrophoresis and normal bone marrow feature, and without symptoms and enlarged organs
Time Frame
up to 6 months
Title
overall survival
Description
time interval between diagnosis and death or last follow-up
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuhua Yi, Doc
Phone
86-22-23909106
Email
yishuhua@ihcams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lugui Qiu, Doc
Phone
86-22-23909172
Email
qiulg@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuhua Yi, Doc
Organizational Affiliation
Blood disease hospital, Chinese Academic Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shuhua Yi
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuhua Yi, Doc
Phone
86-22-23909106
Email
yishuhua@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Lugui Qiu, Doc
Phone
86-22-23909172
Email
qiulg@ihcams.ac.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

EDOCH Alternating With DHAP for New Diagnosed Younger MCL

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