Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02844361
Recruitment Status : Unknown
Verified July 2016 by Yi Shuhua, Institute of Hematology & Blood Diseases Hospital.
Recruitment status was:  Recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Yi Shuhua, Institute of Hematology & Blood Diseases Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Waldenström Macroglobulinemia Other: autologous stem cell transplantation Other: conventional chemotherapy Phase 4

Detailed 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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
Study Start Date : May 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: autologous stem cell transplantation
Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
 Other: autologous stem cell transplantation
Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
Active Comparator: conventional chemotherapy
Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy
 Other: conventional chemotherapy
Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. progress-free survival [ Time Frame: up to 36 months ]

Secondary Outcome Measures :
  1. complete remission rate [ Time Frame: up to 12 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844361


Contacts
Layout table for location contacts
Contact: Shuhua Yi, Doc 86-22-23909106 yishuhua@ihcams.ac.cn
Contact: Lugui Qiu, Doc 86-22-23909172 qiulg@ihcams.ac.cn

Locations
Layout table for location information
China
Shuhua Yi Recruiting
Tianjin, China, 300020
Contact: Shuhua Yi, Doc    86-22-23909106    yishuhua@ihcams.ac.cn   
Contact: Lugui Qiu, Doc    86-22-23909172    qiulg@ihcams.ac.cn   
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
Layout table for investigator information
Principal Investigator: Shuhua Yi, Doc blood disease hospital, Chinese Academic Medical School
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yi Shuhua, Principal Investigator, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT02844361    
Other Study ID Numbers: ITT2015006-EC-2
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: dependent on the local law
Keywords provided by Yi Shuhua, Institute of Hematology & Blood Diseases Hospital:
high-risk
ASCT
Additional relevant MeSH terms:
Layout table for MeSH terms
Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases