The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia (BDH-WM01)

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Unknown; Phase 4

Conditions: Waldenström Macroglobulinemia

Treatments: Drug: Bortezomib; Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT02844322

IIT2015005-EC-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

110 participants in 2 patient groups

Bortezomib

Experimental group

Description:

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.

Treatment:

Drug: Bortezomib

rituximab

Experimental group

Description:

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.

Treatment:

Drug: Rituximab