The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia

NCT ID: NCT02844322

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2023-05-31

Brief Summary

The purpose of this study is to compare the efficacy of cyclophosphamide plus dexamethasone combined with rituximab or bortezomib regimens in newly diagnosed Waldenström macroglobulinemia patients.

Detailed Description

Newly diagnosed WM patients will be randomly assigned to BCD or RCD group for introduction chemotherapy. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will be crossed to control group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patients will quit this study.

Conditions

Waldenström Macroglobulinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bortezomib

Patients in this group will receive bortezomib+ cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a MR or better response achieves, addition 3 cycles will be given. If not, patients will cross to RCD group for another 3 cycles. If a MR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia

rituximab

Patients in this group will receive rituximab+cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a MR or better response achieves, addition 3 cycles will be given. If not, patients will cross to BCD group for another 3 cycles. If a MR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia

Interventions

Bortezomib

compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia

Intervention Type: DRUG

Rituximab

compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia

Intervention Type: DRUG

Other Intervention Names

velcade; Mabthera

Eligibility Criteria

Inclusion Criteria

1. aged >=18 years

2. diagnosed with LPL/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 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
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shuhua Yi, Doc

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Locations

Shuhua Yi

Tianjin, , China

Countries

China

References

Xiong W, Lyu R, Yu Y, Wang T, Yan Y, Wang Y, Liu W, An G, Deng S, Xu Y, Sui W, Huang W, Zou D, Wang J, Qiu L, Yi S. Rituximab plus cyclophosphamide and dexamethasone versus bortezomib plus cyclophosphamide and dexamethasone in newly diagnosed symptomatic Waldenstrom macroglobulinemia: a randomized controlled trial. Haematologica. 2024 May 1;109(5):1614-1618. doi: 10.3324/haematol.2023.284588. No abstract available.

Reference Type: DERIVED

PMID: 38205507 (View on PubMed)

Other Identifiers

IIT2015005

Identifier Type: -

Identifier Source: org_study_id