NCT02844309

Brief Summary

The purpose of this study is to evaluate the efficiency of an oral regimen in newly diagnosed Waldenström macroglobulinemia: thalidomide plus cyclophosphamide and dexamethasone following by thalidomide and prednisone maintenance therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 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
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 11, 2026

Status Verified

May 1, 2024

Enrollment Period

3.5 years

First QC Date

July 17, 2016

Last Update Submit

February 9, 2026

Conditions

Waldenström Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    up to 12 months

Secondary Outcomes (1)

  • progress-free survival

    up to 36 months

Study Arms (1)

Thalidomide

EXPERIMENTAL

thalidomide 50-150mg per night

Drug: Thalidomide

Interventions

ThalidomideDRUG

thalidomide 50-150 mg per night

Also known as: Thal
Thalidomide

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged \>=18 years
  • diagnosed with 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 centre 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;
  • allergy to the trail drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shuhua Yi

Tianjin, 300020, China

Location

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

Thalidomide

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)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
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)