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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Waldenström Macroglobulinemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thalidomide

thalidomide 50-150mg per night

Group Type EXPERIMENTAL

Thalidomide

Intervention Type DRUG

thalidomide 50-150 mg per night

Interventions

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Thalidomide

thalidomide 50-150 mg per night

Intervention Type DRUG

Other Intervention Names

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Thal

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No