Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia (BDH-WM03)

February 9, 2026 updated by: Institute of Hematology & Blood Diseases Hospital, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China, 300020
        • Shuhua Yi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 70 years>=Aged >=18 years
  2. diagnosed with high-risk LPL/WM according to the ISSWM criteria
  3. untreated or mild treated without standard regimens
  4. suitable for ASCT
  5. with life-expectancy more than 3 months.

Exclusion Criteria:

  1. diagnosed with other malignancies outside B-NHL within one year(including active center 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: autologous stem cell transplantation
Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
Procedure: autologous stem cell transplantation
Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
Active Comparator: conventional chemotherapy
Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy
Drug: conventional chemotherapy
Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progress-free survival
Time Frame: up to 36 months
up to 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
complete remission rate
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Investigators

  • Principal Investigator: Shuhua Yi, Doc, blood disease hospital, Chinese Academic Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

July 17, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimated)

July 26, 2016

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2015006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

dependent on the local law

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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