Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia

NCT ID: NCT02844361

Last Updated: 2026-02-11

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

70 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 whether autologous stem cell transplantation will improve the survival of patients with high-risk Waldenström macroglobulinemia, compared with conventional chemotherapy.

Detailed Description

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WM patients with partial response after introduction chemotherapy will be recommended to adopt autologous stem cell transplantation or receive conventional chemotherapy (dependent on patient's choices). After transplantation or conventional chemotherapy, maintenance therapy with rituximab or thalidomide plus prednisone will be given for less than two years.

Conditions

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Waldenström Macroglobulinemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous stem cell transplantation

Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback

Group Type EXPERIMENTAL

autologous stem cell transplantation

Intervention Type PROCEDURE

Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback

conventional chemotherapy

Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy

Group Type ACTIVE_COMPARATOR

conventional chemotherapy

Intervention Type DRUG

Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy

Interventions

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autologous stem cell transplantation

Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback

Intervention Type PROCEDURE

conventional chemotherapy

Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 70 years\>=Aged \>=18 years
2. diagnosed with high-risk LPL/WM according to the ISSWM criteria
3. untreated or mild treated without standard regimens
4. suitable for ASCT
5. with life-expectancy more than 3 months.

Exclusion Criteria

1. diagnosed with other malignancies outside B-NHL within one year(including active center 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

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shuhua Yi, Doc

Role: PRINCIPAL_INVESTIGATOR

blood disease hospital, Chinese Academic Medical School

Locations

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Shuhua Yi

Tianjin, , China

Site Status

Countries

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China

Other Identifiers

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IIT2015006

Identifier Type: -

Identifier Source: org_study_id

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