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

Phase 4

• Conditions: Waldenström Macroglobulinemia
• Interventions: Drug: Thalidomide

• Registration Number: NCT02844309
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-17
• Study First Submitted QC: 2016-07-25
• Last Update Submitted: 2016-07-25
• Study First Posted: 2016-07-26
• Last Update Posted: 2016-07-26
• Primary Completion: 2019-11
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thalidomide	Thalidomide	thalidomide 50-150mg per night

Primary Outcome Measures

Name	Time	Method
Overall response rate	up to 12 months

Secondary Outcome Measures

Name	Time	Method
progress-free survival	up to 36 months

Trial Locations

Locations (1)

Shuhua Yi; 🇨🇳 Tianjin, China