Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia

NCT02844361 | Completed Phase 4

• 1 other identifier: IIT2015006
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Waldenström Macroglobulinemia

Keywords

high-risk; ASCT

Outcome Measures

Primary Outcomes (1)

• progress-free survival

  up to 36 months

Secondary Outcomes (1)

• complete remission rate

  up to 12 months

Study Arms (2)

autologous stem cell transplantation

EXPERIMENTAL

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

Procedure: autologous stem cell transplantation

conventional chemotherapy

ACTIVE COMPARATOR

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

Drug: conventional chemotherapy

Interventions

autologous stem cell transplantation PROCEDURE

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

autologous stem cell transplantation

conventional chemotherapy DRUG

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

conventional chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• diagnosed with other malignancies outside B-NHL within one year(including active center neural system lymphoma)
• transformed lymphoma
• liver or renal function lesion unrelated to lymphoma
• serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician
• HIV positive or active HBV infection or other uncontrolled systematic infection
• clinical central nervous dysfunction
• serious surgery within 30 days
• pregnancy or baby nursing period or un-contracepted child-bearing period woman; 9. allergy to the trail drugs.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Shuhua Yi

Tianjin, 300020, China

Location

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Shuhua Yi, Doc

  blood disease hospital, Chinese Academic Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2016
• First Posted: July 26, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: May 1, 2020
• Last Updated: February 11, 2026

Record last verified: 2024-05

Locations

CN (1)