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

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ClinicalTrials.gov Identifier: NCT02844361
Recruitment Status : 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

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.

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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


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




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 ]


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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.

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
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Contact: Shuhua Yi, Doc 86-22-23909106 yishuhua@ihcams.ac.cn
Contact: Lugui Qiu, Doc 86-22-23909172 qiulg@ihcams.ac.cn

Locations
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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
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Principal Investigator: Shuhua Yi, Doc blood disease hospital, Chinese Academic Medical School

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Responsible Party: Yi Shuhua, Principal Investigator, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT02844361     History of Changes
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:
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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