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Completed

NCT Number: NCT02844322

The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia

The purpose of this study is to compare the efficacy of cyclophosphamide plus dexamethasone combined with rituximab or bortezomib regimens in newly diagnosed Waldenström macroglobulinemia patients.

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Key information

About this study

Newly diagnosed WM patients will be randomly assigned to BCD or RCD group for introduction chemotherapy. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will be crossed to control group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patients will quit this study.

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 LPL/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 center 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; 9. allergy to the trail drugs.

Treatment and study plan

bortezomib

Drug

compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia

Other names: velcade

Rituximab

Drug

compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia

Other names: Mabthera

Primary outcomes

  1. progress-free survival

    Time frame: up to 36 months

Secondary outcomes

  1. Overall response rate

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

The Efficacy of Cyclophosphamide Plus Dexamethasone Combinated With Rituximab or Bortezomib for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Randomized Control Trial From China

Acronym: BDH-WM01

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
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.