The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM (BDH-WM02)

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Unknown; Phase 4

Conditions: Waldenström Macroglobulinemia

Treatments: Drug: Thalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT02844309

IIT2015004-EC-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Thalidomide

Experimental group

Description:

thalidomide 50-150mg per night

Treatment:

Drug: Thalidomide