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

February 9, 2026 updated by: Institute of Hematology & Blood Diseases Hospital, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China, 300020
        • Shuhua Yi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Etoposide
50 mg/m2, IV, d1-4
Drug: Etoposide
50 mg/m2, IV d1-4
Other Names:
  • VP-16
Experimental: Doxorubicin
10 mg/m2, IV, d1-4
Drug: Doxorubicin
10 mg/m2, IV, d1-4
Other Names:
  • adriamycin
Experimental: Dexamethasone
30 mg/d, d1-5
Drug: Dexamethasone
30 mg/d, d1-5
Other Names:
  • Dex
Experimental: Vincristine
0.4 mg/m2, IV, d1-4
Drug: Vincristine
0.4 mg/m2, IV, d1-4
Other Names:
  • VCR
Experimental: Cyclophosphamide
750 mg/m2 ,d5
Drug: Cyclophosphamide
750 mg/m2 ,d5
Other Names:
  • CTX
Experimental: Cytarabine
2g/m2, q12h, d1
Drug: Cytarabine
2g/m2, q12h, d1
Other Names:
  • Ara-c
Experimental: Cisplatin
100mg/ m2,IV, d1
Drug: Cisplatin
100mg/ m2,IV, d1
Other Names:
  • DDP
Experimental: Rituximab
375 mg/m2 IV, d1
Drug: Rituximab
375 mg/m2 IV, d1
Other Names:
  • R
Experimental: Thalidomide
50-150mg/d, po, d1-28
Drug: Thalidomide
50-150mg/d, po, d1-28
Other Names:
  • Thal
Experimental: Prednisone
0.5mg/Kg, po, qod
Drug: Prednisone
0.5mg/Kg, po, qod
Other Names:
  • Pred

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: up to 36 months
the time interval between diagnosis and disease progression or death or last follow-up
up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 6 months
overall survival
Time Frame: up to 36 months
time interval between diagnosis and death or last follow-up
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Investigators

  • Principal Investigator: Shuhua Yi, Doc, blood disease hospital, Chinese Academic Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

July 17, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimated)

August 8, 2016

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2015007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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