- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02844309
The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM (BDH-WM02)
July 25, 2016 updated by: Yi Shuhua, Institute of Hematology & Blood Diseases Hospital
The Efficacy of Thalidomide Plus Cyclophosphamide and Dexamethasone Following by Thalidomide and Prednisone Maintenance Therapy for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
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.
Study Overview
Detailed Description
Enrolled patients will accept maximum 8 cycles of thalidomide plus cyclophosphamide and dexamethasone.
if a partial remission response or better is achieved, thalidomide plus prednisone maintenance therapy will be given for no more than two years.
Study Type
Interventional
Enrollment (Anticipated)
44
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tianjin, China, 300020
- Recruiting
- Shuhua Yi
-
Contact:
- Shuhua Yi, Doc
- Phone Number: 86-22-23909106
- Email: yishuhua@ihcams.ac.cn
-
Contact:
- Lugui Qiu, Doc
- Phone Number: 86-22-23909172
- Email: qiulg@ihcams.ac.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Thalidomide
thalidomide 50-150mg per night
|
thalidomide 50-150 mg per night
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall response rate
Time Frame: up to 12 months
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progress-free survival
Time Frame: up to 36 months
|
up to 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shuhua Yi, Doc, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Anticipated)
November 1, 2019
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
July 17, 2016
First Submitted That Met QC Criteria
July 25, 2016
First Posted (Estimate)
July 26, 2016
Study Record Updates
Last Update Posted (Estimate)
July 26, 2016
Last Update Submitted That Met QC Criteria
July 25, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Waldenstrom Macroglobulinemia
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
Other Study ID Numbers
- IIT2015004-EC-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
whether to publish primary data is dependent on the local law
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Waldenström Macroglobulinemia
-
Dana-Farber Cancer InstituteJanssen, LPCompletedWaldenström MacroglobulinemiaUnited States
-
Central Hospital, Nancy, FranceCompletedWaldenström MacroglobulinemiaFrance
-
Institute of Hematology & Blood Diseases HospitalUnknownWaldenström MacroglobulinemiaChina
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); GlaxoSmithKlineTerminatedWaldenström MacroglobulinemiaUnited States
-
National Cancer Institute (NCI)CompletedWaldenström MacroglobulinemiaUnited States
-
Weill Medical College of Cornell UniversityMayo Clinic; Janssen Scientific Affairs, LLCTerminatedWaldenstrom Macroglobulinemia | Waldenstrom's Macroglobulinemia Recurrent | Waldenstrom's Macroglobulinemia Refractory | Waldenstrom's Disease | Waldenström; Hypergammaglobulinemia | Waldenstrom's Macroglobulinemia of Lymph Nodes | Waldenstrom's Macroglobulinaemia, Without Mention of RemissionUnited States
-
Institute of Hematology & Blood Diseases HospitalRecruitingWaldenström MacroglobulinemiaChina
-
BeiGeneNo longer availableWaldenström MacroglobulinemiaUnited States
-
Institute of Hematology & Blood Diseases HospitalUnknownWaldenström MacroglobulinemiaChina
-
Acerta Pharma BVActive, not recruitingWaldenström Macroglobulinemia (WM)Spain, United States, United Kingdom, France, Italy, Greece, Netherlands
Clinical Trials on Thalidomide
-
Henan Cancer HospitalFirst Affiliated Hospital Xi'an Jiaotong UniversityRecruitingEsophageal Carcinoma | Lung Cancer, Nonsmall CellChina
-
Norwegian University of Science and TechnologyThe Research Council of Norway; Nordic Myeloma Study Group, GermanyCompleted
-
Changzhou No.2 People's HospitalUnknownEsophageal CancerChina
-
Shanghai Pharmaceuticals Holding Co., LtdCompletedAnkylosing SpondylitisChina
-
Shanghai Jiao Tong University School of MedicineChanghai Hospital; Peking Union Medical College Hospital; Shanghai Zhongshan... and other collaboratorsCompletedGastrointestinal Vascular MalformationChina
-
Valme University HospitalUniversity of SevilleUnknown
-
G.V. (Sonny) Montgomery VA Medical CenterUnknownHepatitis C Virus Infection | Infection | Herpesvirus 2, HumanUnited States
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Roswell Park Cancer InstituteCompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific | Graft Versus Host DiseaseUnited States
-
Washington University School of MedicineCelgene CorporationCompleted