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Completed

NCT Number: NCT02844309

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • serious surgery within 30 days
  • pregnancy or baby nursing period or un-contracepted child-bearing period woman;
  • allergy to the trail drugs.

Treatment and study plan

thalidomide

Drug

thalidomide 50-150 mg per night

Other names: Thal

Primary outcomes

  1. Overall response rate

    Time frame: up to 12 months

Secondary outcomes

  1. progress-free survival

    Time frame: up to 36 months

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study 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

Acronym: BDH-WM02

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jul 26, 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.

Published trials that share one or more normalized conditions with this study.