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Trial record 8 of 334 for:    BENDAMUSTINE

Bendamustine Plus Rituximab (BR) for Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)

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: NCT02433795
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : December 3, 2020
Sponsor:
Collaborators:
Gyeongsang National University Hospital
Korea Cancer Center Hospital
Seoul National University Boramae Hospital
Hallym University Medical Center
Inje University
Gangnam Severance Hospital
Chonbuk National University Hospital
Chungnam National University
The Catholic University of Korea
Wonju Severance Christian Hospital
Gachon University Gil Medical Center
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Tae Min Kim, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE April 5, 2015
First Posted Date  ICMJE May 5, 2015
Last Update Posted Date December 3, 2020
Study Start Date  ICMJE May 2015
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2015)
Overall response rate based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2015)
  • Complete remission rate [ Time Frame: 6 months ]
  • Safety based on NCI CTCAE version 4.0 [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bendamustine Plus Rituximab (BR) for Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
Official Title  ICMJE A Phase II Study of Bendamustine Plus Rituximab (BR) in Patients With Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
Brief Summary This study will be conducted to evaluate the efficacy of Bendamustine Plus Rituximab (BR) in patients with relapsed or progressive Marginal Zone B-cell Lymphoma (MZBCL).
Detailed Description Multi-center trial, Phase II, non-randomized, open-label, single-arm study with combined therapy of bendamustine and rituximab in patients with MZBCL who has relapsed or progressive to prior chemotherapy or chemo-radiotherapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Marginal Zone B-cell Lymphoma
Intervention  ICMJE Drug: bendamustine plus rituximab
Bendamustine 90mg/m2 IV on days 1-2 up to 6th cycle Rituximab 375mg/m2 IV on day 1 at 1st cycle Rituximab 1400mg SC on day 1 from 2nd cycle every 4 weeks up to 8th cycle
Study Arms  ICMJE Experimental: Bendamustine plus rituximab(BR)
Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).
Intervention: Drug: bendamustine plus rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2018)
27
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2015)
39
Actual Study Completion Date  ICMJE October 2019
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed CD20-positive nodal or extranodal MZBCL
  2. MZBCL patients who relapsed or progressed:

    • At least one and a maximum of four prior lines of chemotherapy
    • During or after the last chemotherapy or radiotherapy or
    • Without progression within 6 months of the last dose of rituximab-based regimen
  3. Patients age ≥ 18 years
  4. ECOG PS 0-2
  5. At least one bidimensionally measurable disease
  6. Adequate hematologic, renal, and hepatic functions
  7. Women of child-bearing potential should use two appropriate methods of contraception during the study
  8. Written informed consent

Exclusion Criteria:

  1. Not all of the above inclusion criteria are met.
  2. Prior chemotherapy within 4 weeks or radiotherapy within 6 weeks
  3. Corticosteroids during last 28 days except chronic administration of prednisolone at a dose of < 20mg/day for indications other than lymphomas
  4. Evidence of CNS involvement by lymphomas
  5. Active HBV/HCV infections, known HIV infection
  6. Prior diagnosis of cancers within 5 years, except cervical intraepithelial neoplasia type 1, localized non-melanoma skin cancer, or small differentiated thyroid cancer
  7. Serious concurrent disease:
  8. Patients who are pregnant or lactating
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02433795
Other Study ID Numbers  ICMJE LY14-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tae Min Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Gyeongsang National University Hospital
  • Korea Cancer Center Hospital
  • Seoul National University Boramae Hospital
  • Hallym University Medical Center
  • Inje University
  • Gangnam Severance Hospital
  • Chonbuk National University Hospital
  • Chungnam National University
  • The Catholic University of Korea
  • Wonju Severance Christian Hospital
  • Gachon University Gil Medical Center
  • Seoul National University Bundang Hospital
Investigators  ICMJE
Principal Investigator: Dae Seog Heo, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP