Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia (BDH-WM03)

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Unknown; Phase 4

Conditions: Waldenström Macroglobulinemia

Treatments: Other: autologous stem cell transplantation; Other: conventional chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02844361

ITT2015006-EC-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

autologous stem cell transplantation

Experimental group

Description:

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

Treatment:

Other: autologous stem cell transplantation

conventional chemotherapy

Active Comparator group

Description:

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

Treatment:

Other: conventional chemotherapy