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Abbreviated 3 Cycles of Rituximab Plus CHOP(Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised LocalizedGastrointestinal CD(Cluster of Differentiation Antigen)20(+) Diffuse Large B-cell Lymphoma

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Enrolling by invitation
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Abb-R-CHOP
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completely Excised LocalizedGastrointestinal CD20 (+) DLBCL(Diffuse Large B-cell Lymphoma )
  • CD 20, CD5, CD10, MUM-1, BCL-6, BCL-2, Ki-76, EBV(Epstein-Barr virus )positive
  • Lugano Criteria: Stage I, II1
  • Paris Criteria: T1-2NO-1MO
  • Stage-adjusted International Prognostic Index: 0-1
  • A patient who has not previously received chemotherapy or radiation treatment for the DLBCL
  • ECOG(Eastern Cooperative Oncology Group ) :0-2
  • In case of patients who do not have any residual lesion due to complete surgical removal of lymphoma I. A patient who has been confirmed to have no residual lesion in the CT conducted following surgery or Ii. Preoperative imaging confirmed as the first phase of a single lesion and post-operative lesion finding that the patient has been confirmed with
  • In case of a 50 % or higher cardiac output when there is no clinically significant abnormality in MUGA(multiple gated acquisition scan) or deep frequency
  • If appropriate renal function (below serum creatinine 2.0 mg dL or an estimated glomerule filtration rate of 40 mL / mill1.73m2 or higher)
  • If the appropriate liver function is present (serum bilirubin), less than three times the normal upper limit of AST(aspartate aminotransferase ) (non-hepatic) unless the serubin is caused by Gilbert syndrome or originated from a non-hepatic ;
  • Proper Bone marrow function (ANC-1500mm 3 or higher, number of platelets > 755mm3, and hemoglobin 9.0 g/L or higher) If the screening in the CS(cerebrospinal fluid)F is not acceptable, the dose is given in - 7
  • For males, blocking contraceptive methods such as condoms are required at least 6 months from the date of the last administration of the cancer and such measures are agreed
  • For fertile women, it must be agreed to apply contraceptive measures (oral contraceptive pills, in the womb, blocking contraceptive methods, etc.) for at least 6 months from the date of administration of the last cancer.
  • decided to participate in this study voluntarily and agree in writing

Exclusion Criteria:

  • HIV or HCV(hepatitis C virus) positive patient. However, HBVhepatitis B virus) positive patients using anti-viral therapy are allowed
  • Patient with current history of other cancers (e.g. cervical carcinoma in situ, treated basal cell carcinoma, early cancer, excluded from the present condition of cancer.
  • pregnant or nursing woman, male or female who do not agree with appropriate contraception.
  • Systemic disease that is inappropriate for administration of anticancer drugs I. A patient who within the past 6 months had a clinically significant heart attack (non-medical congestive heart failure, symptomatic coronary artery disease, severe myocardial infarction) or Ii. Serious neurology and psychiatric disease Iii. Serious activity infection Iv. Other medical conditions that are difficult to perform in clinical trials
  • If you are allergic to chemicals used in this study
  • Patients who receive another test medication during a clinical trial or who is administered both chemotherapy, hormone therapy and immunization
  • Patient with Bulky disease (length of diaphragm 10 cm)
  • Patient who is unsuitable for participation in a clinical examination according to the judgment of a researcher

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Abb-R-CHOP

    Arm Description

    Outcomes

    Primary Outcome Measures

    Response
    CT(Computed tomography) / PET-CT(Positron emission computed tomography)/ Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO

    Secondary Outcome Measures

    Assess response rate
    CT/ PET-CT/Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO
    Assess response rate
    CT/ PET-CT/Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO

    Full Information

    First Posted
    December 25, 2017
    Last Updated
    January 8, 2018
    Sponsor
    Asan Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03399747
    Brief Title
    Abbreviated 3 Cycles of Rituximab Plus CHOP(Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised LocalizedGastrointestinal CD(Cluster of Differentiation Antigen)20(+) Diffuse Large B-cell Lymphoma
    Official Title
    Phase 2 Study of Abbreviated 3 Cycles of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised LocalizedGastrointestinal CD20 (+) Diffuse Large B-cell Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Enrolling by invitation
    Study Start Date
    December 7, 2016 (Actual)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Asan Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Phase 2 Study of Abbreviated 3 Cycles of Rituximab plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients with Completely Excised Localized Gastrointestinal CD20 (+) Diffuse Large B-cell Lymphoma(SATURDAY STUDY)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diffuse Large B-cell Lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Abb-R-CHOP
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Abb-R-CHOP
    Intervention Description
    Completely Excised LocalizedGastrointestinal CD20 (+) Diffuse Large B-cell Lymphoma 3 Cycles(1 Cycle:4weeks) of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy
    Primary Outcome Measure Information:
    Title
    Response
    Description
    CT(Computed tomography) / PET-CT(Positron emission computed tomography)/ Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO
    Time Frame
    6 to 8 weeks after completion of the 3rd cycle of treatment(each cycle is 28days)
    Secondary Outcome Measure Information:
    Title
    Assess response rate
    Description
    CT/ PET-CT/Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO
    Time Frame
    after completion of the treatment, up to 2years
    Title
    Assess response rate
    Description
    CT/ PET-CT/Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO
    Time Frame
    after completion of the treatment, up to 4years
    Other Pre-specified Outcome Measures:
    Title
    Assess overall survival
    Description
    CT/ PET-CT/Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO
    Time Frame
    after completion of the treatment, up to 5years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Completely Excised LocalizedGastrointestinal CD20 (+) DLBCL(Diffuse Large B-cell Lymphoma ) CD 20, CD5, CD10, MUM-1, BCL-6, BCL-2, Ki-76, EBV(Epstein-Barr virus )positive Lugano Criteria: Stage I, II1 Paris Criteria: T1-2NO-1MO Stage-adjusted International Prognostic Index: 0-1 A patient who has not previously received chemotherapy or radiation treatment for the DLBCL ECOG(Eastern Cooperative Oncology Group ) :0-2 In case of patients who do not have any residual lesion due to complete surgical removal of lymphoma I. A patient who has been confirmed to have no residual lesion in the CT conducted following surgery or Ii. Preoperative imaging confirmed as the first phase of a single lesion and post-operative lesion finding that the patient has been confirmed with In case of a 50 % or higher cardiac output when there is no clinically significant abnormality in MUGA(multiple gated acquisition scan) or deep frequency If appropriate renal function (below serum creatinine 2.0 mg dL or an estimated glomerule filtration rate of 40 mL / mill1.73m2 or higher) If the appropriate liver function is present (serum bilirubin), less than three times the normal upper limit of AST(aspartate aminotransferase ) (non-hepatic) unless the serubin is caused by Gilbert syndrome or originated from a non-hepatic ; Proper Bone marrow function (ANC-1500mm 3 or higher, number of platelets > 755mm3, and hemoglobin 9.0 g/L or higher) If the screening in the CS(cerebrospinal fluid)F is not acceptable, the dose is given in - 7 For males, blocking contraceptive methods such as condoms are required at least 6 months from the date of the last administration of the cancer and such measures are agreed For fertile women, it must be agreed to apply contraceptive measures (oral contraceptive pills, in the womb, blocking contraceptive methods, etc.) for at least 6 months from the date of administration of the last cancer. decided to participate in this study voluntarily and agree in writing Exclusion Criteria: HIV or HCV(hepatitis C virus) positive patient. However, HBVhepatitis B virus) positive patients using anti-viral therapy are allowed Patient with current history of other cancers (e.g. cervical carcinoma in situ, treated basal cell carcinoma, early cancer, excluded from the present condition of cancer. pregnant or nursing woman, male or female who do not agree with appropriate contraception. Systemic disease that is inappropriate for administration of anticancer drugs I. A patient who within the past 6 months had a clinically significant heart attack (non-medical congestive heart failure, symptomatic coronary artery disease, severe myocardial infarction) or Ii. Serious neurology and psychiatric disease Iii. Serious activity infection Iv. Other medical conditions that are difficult to perform in clinical trials If you are allergic to chemicals used in this study Patients who receive another test medication during a clinical trial or who is administered both chemotherapy, hormone therapy and immunization Patient with Bulky disease (length of diaphragm 10 cm) Patient who is unsuitable for participation in a clinical examination according to the judgment of a researcher

    12. IPD Sharing Statement

    Learn more about this trial

    Abbreviated 3 Cycles of Rituximab Plus CHOP(Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised LocalizedGastrointestinal CD(Cluster of Differentiation Antigen)20(+) Diffuse Large B-cell Lymphoma

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