EDOCH Alternating With DHAP for New Diagnosed Younger MCL

NCT ID: NCT02858804

Last Updated: 2019-06-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mantle Cell Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etoposide

50 mg/m2, IV, d1-4

Group Type EXPERIMENTAL

Etoposide

Intervention Type DRUG

50 mg/m2, IV d1-4

Doxorubicin

10 mg/m2, IV, d1-4

Group Type EXPERIMENTAL

Doxorubicin

Intervention Type DRUG

10 mg/m2, IV, d1-4

Dexamethasone

30 mg/d, d1-5

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

30 mg/d, d1-5

Vincristine

0.4 mg/m2, IV, d1-4

Group Type EXPERIMENTAL

Vincristine

Intervention Type DRUG

0.4 mg/m2, IV, d1-4

Cyclophosphamide

750 mg/m2 ,d5

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

750 mg/m2 ,d5

Cytarabine

2g/m2, q12h, d1

Group Type EXPERIMENTAL

Cytarabine

Intervention Type DRUG

2g/m2, q12h, d1

Cisplatin

100mg/ m2,IV, d1

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

100mg/ m2,IV, d1

Rituximab

375 mg/m2 IV, d1

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

375 mg/m2 IV, d1

Thalidomide

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

Group Type EXPERIMENTAL

Thalidomide

Intervention Type DRUG

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

Prednisone

0.5mg/Kg, po, qod

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

0.5mg/Kg, po, qod

Interventions

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Etoposide

50 mg/m2, IV d1-4

Intervention Type DRUG

Doxorubicin

10 mg/m2, IV, d1-4

Intervention Type DRUG

Dexamethasone

30 mg/d, d1-5

Intervention Type DRUG

Vincristine

0.4 mg/m2, IV, d1-4

Intervention Type DRUG

Cyclophosphamide

750 mg/m2 ,d5

Intervention Type DRUG

Cytarabine

2g/m2, q12h, d1

Intervention Type DRUG

Cisplatin

100mg/ m2,IV, d1

Intervention Type DRUG

Rituximab

375 mg/m2 IV, d1

Intervention Type DRUG

Thalidomide

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

Intervention Type DRUG

Prednisone

0.5mg/Kg, po, qod

Intervention Type DRUG

Other Intervention Names

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VP-16 adriamycin Dex VCR CTX Ara-c DDP R Thal Pred

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Yi Shuhua

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuhua Yi, Doc

Role: CONTACT

86-22-23909106

Lugui Qiu, Doc

Role: CONTACT

86-22-23909172

Facility Contacts

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Shuhua Yi, Doc

Role: primary

86-22-23909106

Lugui Qiu, Doc

Role: backup

86-22-23909172

Other Identifiers

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IIT2015007-EC-1

Identifier Type: -

Identifier Source: org_study_id

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