CompletedPhase 4

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

China44 participantsStarted 2016-05

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. diagnosed with other malignancies outside B-NHL within one year(including active centre neural system lymphoma)
✕. Transformed lymphoma
✕. liver or renal function lesion unrelated to lymphoma
✕. serious complications such as uncontrolled diabetes,gastric ulcer or other serious angiocardiopathy determined by the physician
✕. HIV positive or active HBV infection or other uncontrolled systematic infection
✕. clinical central nervous dysfunction
✕. serious surgery within 30 days
✕. pregnancy or baby nursing period or un-contracepted child-bearing period woman;

What they're measuring

Overall response rate

Timeframe: up to 12 months

Trial details

NCT IDNCT02844309

SponsorInstitute of Hematology & Blood Diseases Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11

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