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Trial record 5 of 315 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 : Active, not recruiting
First Posted : May 5, 2015
Last Update Posted : June 21, 2018
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):
Dae Seog Heo, Seoul National University Hospital

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).

Condition or disease Intervention/treatment Phase
Marginal Zone B-cell Lymphoma Drug: bendamustine plus rituximab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Bendamustine Plus Rituximab (BR) in Patients With Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
Study Start Date : May 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Bendamustine plus rituximab(BR)
Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).
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




Primary Outcome Measures :
  1. Overall response rate based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Complete remission rate [ Time Frame: 6 months ]
  2. Safety based on NCI CTCAE version 4.0 [ Time Frame: 1 year ]


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

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

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): NCT02433795


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
Hallym University Medical Center
Anyang-si, Korea, Republic of
Chungnam National University
Daejeon, Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Gyeongsang National University Hospital
Jinju, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Inje Universit
Seoul, Korea, Republic of
Korea Cancer Center Hospital
Seoul, Korea, Republic of
Seoul National University Boramae Hospital
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
The Catholic University of Korea
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
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
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Principal Investigator: Dae Seog Heo, MD, PhD Seoul National University Hospital

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Responsible Party: Dae Seog Heo, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02433795     History of Changes
Other Study ID Numbers: LY14-09
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Keywords provided by Dae Seog Heo, Seoul National University Hospital:
Marginal zone B-cell lymphoma
bendamustine plus rituximab
Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Lymphoma
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action