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CompletedNCT02844309BDH-WM02Updated Feb 11, 2026

The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM

A Phase 4 interventional study of Thalidomide in Waldenström Macroglobulinemia, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Waldenström Macroglobulinemia
03

In context

Waldenstrom Macroglobulinemia

365 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 62 are open to participants now.

This study's enrollment of 44 is close to the median of 40 across 316 interventional studies indexed under Waldenstrom Macroglobulinemia.

Browse Waldenstrom Macroglobulinemia studies →

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged >=18 years
  2. diagnosed with WM
  3. Untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib
  4. symptom patients
  5. with life-expectancy more than 3 months.

Exclusion criteria

Exclusion Criteria:

  1. diagnosed with other malignancies outside B-NHL within one year(including active centre neural system lymphoma)
  2. Transformed lymphoma
  3. liver or renal function lesion unrelated to lymphoma
  4. serious complications such as uncontrolled diabetes,gastric ulcer or other serious angiocardiopathy determined by the physician
  5. HIV positive or active HBV infection or other uncontrolled systematic infection
  6. clinical central nervous dysfunction
  7. serious surgery within 30 days
  8. pregnancy or baby nursing period or un-contracepted child-bearing period woman;
  9. allergy to the trail drugs.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Thalidomide

    thalidomide 50-150mg per night

    Drug: Thalidomide

Interventions

  • DrugThalidomide

    thalidomide 50-150 mg per night

    Also known as: Thal

06

What researchers measure

Primary outcomes

  1. Overall response rate

    Time frame: up to 12 months

Secondary outcomes

  1. progress-free survival

    Time frame: up to 36 months

07

Study locations

1 site
  • Shuhua Yi
    Tianjin, 300020, China
08

References and documents

Individual participant data

Plan to share: Undecided — whether to publish primary data is dependent on the local law

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02844309
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Responsible party
Sponsor
First posted
Jul 26, 2016
Start date
May 2016
Primary completion
Nov 2019
Completion
May 2020
Last update
Feb 11, 2026

Study contacts

Shuhua Yi, Doc
principal investigator · institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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