Mantle Cell LymphomaPhase 4BDH-MCL01NCT02858804
EDOCH Alternating With DHAP for New Diagnosed Younger MCL
A Phase 4 study testing Etoposide, Doxorubicin and Dexamethasone in people with Mantle Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Etoposide, Doxorubicin and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Etoposide, Doxorubicin, Dexamethasone, Vincristine, Cyclophosphamide
- Keywords
- mantle cell lymphoma, EDOCH, DHAP, maintenance therapy
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
Also called VP-16
50 mg/m2, IV d1-4
DoxorubicinDrug
Also called adriamycin
10 mg/m2, IV, d1-4
DexamethasoneDrug
Also called Dex
30 mg/d, d1-5
VincristineDrug
Also called VCR
0.4 mg/m2, IV, d1-4
CyclophosphamideDrug
Also called CTX
750 mg/m2 ,d5
CytarabineDrug
Also called Ara-c
2g/m2, q12h, d1
CisplatinDrug
Also called DDP
100mg/ m2,IV, d1
RituximabDrug
Also called R
375 mg/m2 IV, d1
ThalidomideDrug
Also called Thal
50-150mg/d, po, d1-28
PrednisoneDrug
Also called Pred
0.5mg/Kg, po, qod
| Study group | Role | What they receive |
|---|---|---|
| Etoposide | Experimental | 50 mg/m2, IV, d1-4 Receives: Drug: Etoposide |
| Doxorubicin | Experimental | 10 mg/m2, IV, d1-4 Receives: Drug: Doxorubicin |
| Dexamethasone | Experimental | 30 mg/d, d1-5 Receives: Drug: Dexamethasone |
| Vincristine | Experimental | 0.4 mg/m2, IV, d1-4 Receives: Drug: Vincristine |
| Cyclophosphamide | Experimental | 750 mg/m2 ,d5 Receives: Drug: Cyclophosphamide |
| Cytarabine | Experimental | 2g/m2, q12h, d1 Receives: Drug: Cytarabine |
| Cisplatin | Experimental | 100mg/ m2,IV, d1 Receives: Drug: Cisplatin |
| Rituximab | Experimental | 375 mg/m2 IV, d1 Receives: Drug: Rituximab |
| Thalidomide | Experimental | 50-150mg/d, po, d1-28 Receives: Drug: Thalidomide |
| Prednisone | Experimental | 0.5mg/Kg, po, qod Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
the time interval between diagnosis and disease progression or death or last follow-up
Measured: up to 36 months
Secondary outcomes (2)
complete remission
measure with normal serum immunofixation electrophoresis and normal bone marrow feature, and without symptoms and enlarged organs
Measured: up to 6 months
overall survival
time interval between diagnosis and death or last follow-up
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuhua Yi, Doc, Principal investigator, Blood disease hospital, Chinese Academic Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858804
- Sponsor's protocol ID
- IIT2015007
- Acronym
- BDH-MCL01
- Status last verified
- May 2024
- First submitted
- 17 Jul 2016
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02858804
- Acronym / sponsor ID
- BDH-MCL01 / IIT2015007
- Conditions
- Mantle Cell Lymphoma
- Keywords
- mantle cell lymphoma, EDOCH, DHAP, maintenance therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Etoposide | Experimental | Drug: Etoposide50 mg/m2, IV, d1-4 |
| Doxorubicin | Experimental | Drug: Doxorubicin10 mg/m2, IV, d1-4 |
| Dexamethasone | Experimental | Drug: Dexamethasone30 mg/d, d1-5 |
| Vincristine | Experimental | Drug: Vincristine0.4 mg/m2, IV, d1-4 |
| Cyclophosphamide | Experimental | Drug: Cyclophosphamide750 mg/m2 ,d5 |
| Cytarabine | Experimental | Drug: Cytarabine2g/m2, q12h, d1 |
| Cisplatin | Experimental | Drug: Cisplatin100mg/ m2,IV, d1 |
| Rituximab | Experimental | Drug: Rituximab375 mg/m2 IV, d1 |
| Thalidomide | Experimental | Drug: Thalidomide50-150mg/d, po, d1-28 |
| Prednisone | Experimental | Drug: Prednisone0.5mg/Kg, po, qod |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtoposideAlso: VP-1650 mg/m2, IV d1-4 | Drug | Etoposide |
| DoxorubicinAlso: adriamycin10 mg/m2, IV, d1-4 | Drug | Doxorubicin |
| DexamethasoneAlso: Dex30 mg/d, d1-5 | Drug | Dexamethasone |
| VincristineAlso: VCR0.4 mg/m2, IV, d1-4 | Drug | Vincristine |
| CyclophosphamideAlso: CTX750 mg/m2 ,d5 | Drug | Cyclophosphamide |
| CytarabineAlso: Ara-c2g/m2, q12h, d1 | Drug | Cytarabine |
| CisplatinAlso: DDP100mg/ m2,IV, d1 | Drug | Cisplatin |
| RituximabAlso: R375 mg/m2 IV, d1 | Drug | Rituximab |
| ThalidomideAlso: Thal50-150mg/d, po, d1-28 | Drug | Thalidomide |
| PrednisoneAlso: Pred0.5mg/Kg, po, qod | Drug | Prednisone |
Primary outcome
progression free survival
Time frame: up to 36 months
the time interval between diagnosis and disease progression or death or last follow-up
2 secondary outcomes
complete remission
Time frame: up to 6 months
overall survival
Time frame: up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuhua Yi, Doc principal investigator
Blood disease hospital, Chinese Academic Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etoposide, Doxorubicin and Dexamethasone in people with Mantle Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.