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The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia (BDH-WM01)

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ClinicalTrials.gov Identifier: NCT02844322
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 compare the efficacy of cyclophosphamide plus dexamethasone combined with rituximab or bortezomib regimens in newly diagnosed Waldenström macroglobulinemia patients.

Condition or disease Intervention/treatment Phase
Waldenström Macroglobulinemia Drug: Bortezomib Drug: Rituximab Phase 4

Detailed Description:
Newly diagnosed WM patients will be randomly assigned to BCD or RCD group for introduction chemotherapy. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will be crossed to control group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patients will quit this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Cyclophosphamide Plus Dexamethasone Combinated With Rituximab or Bortezomib for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Randomized Control Trial From China
Study Start Date : May 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Experimental: Bortezomib
Patients in this group will receive bortezomib+ cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will cross to RCD group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.
Drug: Bortezomib
compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia
Other Name: velcade

Experimental: rituximab
Patients in this group will receive rituximab+cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will cross to BCD group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.
Drug: Rituximab
compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia
Other Name: Mabthera




Primary Outcome Measures :
  1. overall response rate [ Time Frame: up to 12 months ]

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


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. aged >=18 years
  2. diagnosed with LPL/WM
  3. untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib
  4. symptom patients
  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): NCT02844322


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

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Responsible Party: Yi Shuhua, Principal Investigator, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT02844322     History of Changes
Other Study ID Numbers: IIT2015005-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: we will make the data publicly available according to the local law

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
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Rituximab
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists