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Completed

NCT Number: NCT02858804

EDOCH Alternating With DHAP for New Diagnosed Younger MCL

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shuhua Yi

Tianjin, 300020, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etoposide

Drug

50 mg/m2, IV d1-4

Other names: VP-16

Doxorubicin

Drug

10 mg/m2, IV, d1-4

Other names: adriamycin

Dexamethasone

Drug

30 mg/d, d1-5

Other names: Dex

Vincristine

Drug

0.4 mg/m2, IV, d1-4

Other names: VCR

Cyclophosphamide

Drug

750 mg/m2 ,d5

Other names: CTX

Cytarabine

Drug

2g/m2, q12h, d1

Other names: Ara-c

Cisplatin

Drug

100mg/ m2,IV, d1

Other names: DDP

Rituximab

Drug

375 mg/m2 IV, d1

Other names: R

thalidomide

Drug

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

Other names: Thal

Prednisone

Drug

0.5mg/Kg, po, qod

Other names: Pred

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study 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

Acronym: BDH-MCL01

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Aug 8, 2016
Registry last updated
Feb 11, 2026

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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