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

Diffuse Large B-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03399747
• Other study ID #: Asan_LMP2017-002
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: December 25, 2017
• Last updated: January 8, 2018
• Start date: December 7, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Abb-R-CHOP
Completely Excised LocalizedGastrointestinal CD20 (+) Diffuse Large B-cell Lymphoma 3 Cycles(1 Cycle:4weeks) of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess overall survival	CT/ PET-CT/Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO	after completion of the treatment, up to 5years
Primary	Response	CT(Computed tomography) / PET-CT(Positron emission computed tomography)/ Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO	6 to 8 weeks after completion of the 3rd cycle of treatment(each cycle is 28days)
Secondary	Assess response rate	CT/ PET-CT/Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO	after completion of the treatment, up to 2years
Secondary	Assess response rate	CT/ PET-CT/Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO	after completion of the treatment, up to 4years