Waldenström MacroglobulinemiaPhase 4BDH-WM02NCT02844309
The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM
A Phase 4 study testing Thalidomide in people with Waldenström Macroglobulinemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficiency of an oral regimen in newly diagnosed Waldenström macroglobulinemia: thalidomide plus cyclophosphamide and dexamethasone following by thalidomide and prednisone maintenance therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Waldenström Macroglobulinemia
- What is being tested?
- Thalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- May 2016to May 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >=18 years
- diagnosed with WM
- Untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib
- symptom patients
- with life-expectancy more than 3 months.
Who cannot join
- diagnosed with other malignancies outside B-NHL within one year(including active centre neural system lymphoma)
- Transformed lymphoma
- liver or renal function lesion unrelated to lymphoma
- 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
Show all 9Show fewer
- serious surgery within 30 days
- pregnancy or baby nursing period or un-contracepted child-bearing period woman;
- allergy to the trail drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Thalidomide Plus Cyclophosphamide and Dexamethasone Following by Thalidomide and Prednisone Maintenance Therapy for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
The purpose of this study is to evaluate the efficiency of an oral regimen in newly diagnosed Waldenström macroglobulinemia: thalidomide plus cyclophosphamide and dexamethasone following by thalidomide and prednisone maintenance therapy.
Read the detailed description
Enrolled patients will accept maximum 8 cycles of thalidomide plus cyclophosphamide and dexamethasone. if a partial remission response or better is achieved, thalidomide plus prednisone maintenance therapy will be given for no more than two years.
- Conditions
- Waldenström Macroglobulinemia
- Being tested
- Thalidomide
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Also called Thal
thalidomide 50-150 mg per night
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide | Experimental | thalidomide 50-150mg per night Receives: Drug: Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: up to 12 months
Secondary outcomes (1)
progress-free survival
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 posted26 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2019
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenström MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuhua Yi, Doc, Principal investigator, institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844309
- Sponsor's protocol ID
- IIT2015004
- Acronym
- BDH-WM02
- 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: whether to publish primary data is dependent on the local law
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
- The Efficacy of Thalidomide Plus Cyclophosphamide and Dexamethasone Following by Thalidomide and Prednisone Maintenance Therapy for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
- ClinicalTrials.gov ID
- NCT02844309
- Acronym / sponsor ID
- BDH-WM02 / IIT2015004
- Conditions
- Waldenström Macroglobulinemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 26 Jul 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 evaluate the efficiency of an oral regimen in newly diagnosed Waldenström macroglobulinemia: thalidomide plus cyclophosphamide and dexamethasone following by thalidomide and prednisone maintenance therapy.
Detailed description
Enrolled patients will accept maximum 8 cycles of thalidomide plus cyclophosphamide and dexamethasone. if a partial remission response or better is achieved, thalidomide plus prednisone maintenance therapy will be given for no more than two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalidomide | Experimental | Drug: Thalidomidethalidomide 50-150mg per night |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged >=18 years
- diagnosed with WM
- Untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib
- symptom patients
- with life-expectancy more than 3 months.
Key exclusion criteria (9 listed)
- diagnosed with other malignancies outside B-NHL within one year(including active centre neural system lymphoma)
- Transformed lymphoma
- liver or renal function lesion unrelated to lymphoma
- 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
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 |
|---|---|---|
| ThalidomideAlso: Thalthalidomide 50-150 mg per night | Drug | Thalidomide |
Primary outcome
Overall response rate
Time frame: up to 12 months
1 secondary outcome
progress-free 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. whether to publish primary data is dependent on the local law
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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
institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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 Thalidomide in people with Waldenström Macroglobulinemia, 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 5 inclusion and 9 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?
Overall response rate (time frame: up to 12 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.