NCT02844322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

February 11, 2026

Status Verified

March 1, 2024

Enrollment Period

6 years

First QC Date

July 17, 2016

Last Update Submit

February 9, 2026

Conditions

Waldenström Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • progress-free survival

    up to 36 months

Secondary Outcomes (1)

  • Overall response rate

    up to 12 months

Study Arms (2)

Bortezomib

EXPERIMENTAL

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.

Drug: Bortezomib

rituximab

EXPERIMENTAL

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.

Drug: Rituximab

Interventions

BortezomibDRUG

compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia

Also known as: velcade
Bortezomib
RituximabDRUG

compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia

Also known as: Mabthera
rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged \>=18 years
  • diagnosed with LPL/WM
  • untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib
  • symptom patients
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shuhua Yi

Tianjin, 300020, China

Location

Related Publications (1)

  • 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.

    PMID: 38205507DERIVED

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

BortezomibRituximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Shuhua Yi, Doc

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
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

May 1, 2022

Study Completion

May 1, 2023

Last Updated

February 11, 2026

Record last verified: 2024-03

Locations

CN(1)