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NCT Number: NCT02844361

Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia

The purpose of this study is to evaluate whether autologous stem cell transplantation will improve the survival of patients with high-risk Waldenström macroglobulinemia, compared with conventional chemotherapy.

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Key information

Conditions

Waldenström Macroglobulinemia Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases Waldenstrom Macroglobulinemia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shuhua Yi

Tianjin, 300020, China

About this study

WM patients with partial response after introduction chemotherapy will be recommended to adopt autologous stem cell transplantation or receive conventional chemotherapy (dependent on patient's choices). After transplantation or conventional chemotherapy, maintenance therapy with rituximab or thalidomide plus prednisone will be given for less than two years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 70 years>=Aged >=18 years
  • diagnosed with high-risk LPL/WM according to the ISSWM criteria
  • untreated or mild treated without standard regimens
  • suitable for ASCT
  • 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

Autologous Stem Cell Transplantation

Procedure

Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback

conventional chemotherapy

Drug

Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy

Primary outcomes

  1. progress-free survival

    Time frame: up to 36 months

Secondary outcomes

  1. complete remission 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

Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China

Acronym: BDH-WM03

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.

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