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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02844309

Acronym

BDH-WM02

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

Brief summary

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.

Detailed description

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.

Interventions

DRUGThalidomide

thalidomide 50-150 mg per night

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Aged \>=18 years 2. diagnosed with WM 3. Untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib 4. symptom patients 5. with life-expectancy more than 3 months.

Exclusion criteria

1. diagnosed with other malignancies outside B-NHL within one year(including active centre 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
Overall response rate	up to 12 months

Secondary

Measure	Time frame
progress-free survival	up to 36 months

Countries

China

Contacts

PRINCIPAL_INVESTIGATORShuhua Yi, Doc

institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Outcome results

None listed

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