R-CHOP Alone vs. R-CHOP Plus Radiotherapy for Localized CD20+ DLBCL

NCT ID: NCT02054559

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2020-01-31

Brief Summary

To compare the efficacy and safety of chemotherapy alone and combined modality therapy in the treatment of localized CD20 (+) diffuse large B-cell lymphoma

Conditions

Diffuse Large B-cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Total 6 cycles of R-CHOP

Group Type: ACTIVE_COMPARATOR

R-CHOP

Intervention Type: DRUG

R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (or prednisolone))

Total 3 cycles of R-CHOP + RT

Total 3 cycles of R-CHOP followed by radiotherapy (involved field or involved site radiotherapy, 30-50 Gy/ 15-25 fractions)

Group Type: EXPERIMENTAL

R-CHOP

Intervention Type: DRUG

R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (or prednisolone))

Radiotherapy

Intervention Type: RADIATION

Interventions

R-CHOP

R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (or prednisolone))

Intervention Type: DRUG

Radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Histologically confirmed CD20-positive Diffuse Large B-cell Lymphoma (DLBCL), NOS
• Immunostains for CD20, CD5, CD3, CD10, MUM-1, BCL-6, BCL-2 and Ki-67 and the in situ hybridization for Epstein-Barr virus are recommended for diagnosis of DLBCL, NOS.
• No prior treatment for DLBCL
• Stage I or contiguous II disease (Involvement of two adjacent lymph node regions or organ involvement with regional lymph nodes)
• Performance status: ECOG 0-2.
• Age ≥ 18 years
• Cardiac ejection fraction ≥ 45% as measured by MUGA or 2D ECHO without clinically significant abnormalities
• Adequate renal function: serum creatinine level < 2 mg/dL
• Adequate liver functions
• Adequate hematological function: hemoglobin ≥ 9.0 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma
• Life expectancy >= 6 months
• A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are < 1 years after the onset of menopause.
• Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device,diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; Males must use an effective method of birth control during treatment period and 3 months thereafter.

Exclusion Criteria

• Other subtypes NHL than CD20 (+) DLBCL, NOS
• Transformed DLBCL from follicular lymphoma or other indolent lymphomas
• Bulky disease ( longest diameter >=10 cm)
• Previous treatment for DLBCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before inclusion
• CNS involvement by lymphoma or any evidence of spinal cord compression.
• Primary Central Nervous System (CNS) DLBCL
• Primary testicular lymphoma
• Primary breast lymphoma
• Patients with a known history of HIV seropositivity or HCV (+). (Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine, etc) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.)
• Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin, early gastric cancer or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
• Pregnant or lactating women
• Men who are not surgically sterile and women of childbearing potential not employing adequate contraception
• Other serious illness or medical conditions
• Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
• History of significant neurological or psychiatric disorders including dementia or seizures
• Active uncontrolled infection (viral, bacterial or fungal infection)
• Other serious medical illnesses
• Known hypersensitivity to any of the study drugs or its ingredients
• Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Cheolwon Suh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AMC_NHL02

Identifier Type: -

Identifier Source: org_study_id