The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia

Phase 4

• Conditions: Waldenström Macroglobulinemia
• Interventions: Drug: Bortezomib; Drug: Rituximab

• Registration Number: NCT02844322
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-17
• Study First Submitted QC: 2016-07-25
• Last Update Submitted: 2016-07-25
• Study First Posted: 2016-07-26
• Last Update Posted: 2016-07-26
• Primary Completion: 2019-11
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bortezomib	Bortezomib	Patients in this group will receive bortezomib+ cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. 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 cross to RCD group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.
rituximab	Rituximab	Patients in this group will receive rituximab+cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. 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 cross to BCD group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.

Primary Outcome Measures

Name	Time	Method
overall response rate	up to 12 months

Secondary Outcome Measures

Name	Time	Method
progress-free survival	up to 36 months

Trial Locations

Locations (1)

Shuhua Yi; 🇨🇳 Tianjin, China