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

NCT02054559 | Withdrawn Phase 3 DMC

• 1 other identifier: AMC_NHL02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

localized; diffuse large B-cell lymphoma; R-CHOP chemotherapy; radiotherapy

Outcome Measures

Primary Outcomes (1)

• To compare 3-year event-free survival

  definition of events: failure to achieve CR after completion of planned 1st-line treatment, progression of disease, relapse, institution of a new anticancer treatment or any cause of death) rate in patients with CD20 (+) diffuse large B-cell lymphoma treated with either R-CHOP chemotherapy alone or R-CHOP plus radiotherapy

  3 years

Secondary Outcomes (7)

• To evaluate and compare OS between the two arms

  3 years

• To evaluate and compare the ORR and CR rate

  after completion of treatment

• To evaluate and compare disease-free survival (DFS)

  3 years

• To evaluate treatment-failure pattern

  3 years

• Number of Participants with Adverse Events in each arm

  3 years

Study Arms (2)

Total 6 cycles of R-CHOP

ACTIVE COMPARATOR

Drug: R-CHOP

Total 3 cycles of R-CHOP + RT

EXPERIMENTAL

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

Drug: R-CHOP; Radiation: Radiotherapy

Interventions

R-CHOP DRUG

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

Total 3 cycles of R-CHOP + RT; Total 6 cycles of R-CHOP

Radiotherapy RADIATION

Total 3 cycles of R-CHOP + RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Other subtypes NHL than CD20 (+) DLBCL, NOS
• Transformed DLBCL from follicular lymphoma or other indolent lymphomas
• Bulky disease ( longest diameter \>=10 cm)
• 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)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

R-CHOP protocol; Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: February 4, 2014
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

KR (1)