Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02844361

Acronym

BDH-WM03

Enrollment

Registered

2016-07-26

Start date

2016-05-01

Completion date

2020-05-01

Last updated

2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Waldenström Macroglobulinemia

Keywords

high-risk, ASCT

Brief summary

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.

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.

Interventions

PROCEDUREautologous 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

DRUGconventional chemotherapy

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
progress-free survival	up to 36 months

Secondary

Measure	Time frame
complete remission rate	up to 12 months

Countries

China

Contacts

PRINCIPAL_INVESTIGATORShuhua Yi, Doc

blood disease hospital, Chinese Academic Medical School

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026