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

Diffuse Large B-cell Lymphoma Clinical Trial

— ASPIRE  

Official title:

Randomized Phase III Trial Comparing R-CHOP Alone and R-CHOP Plus Radiotherapy for Localized CD20+ Diffuse Large B-cell Lymphoma (DLBCL)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02054559
• Other study ID #: AMC_NHL02
• Status: Withdrawn
• Phase: Phase 3
• First received: January 29, 2014
• Last updated: February 20, 2016
• Est. completion date: January 2020

Study information

• Verified date: February 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Radiation:
• Radiotherapy

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate and compare OS between the two arms		3 years	No
Secondary	To evaluate and compare the ORR and CR rate		after completion of treatment	No
Secondary	To evaluate and compare disease-free survival (DFS)		3 years	No
Secondary	To evaluate treatment-failure pattern		3 years	No
Secondary	Number of Participants with Adverse Events in each arm		3 years	No
Secondary	To assess patient-reported outcomes (PROs) in both arms		3 years	No
Secondary	A role of interim PET after 3 cycles of R-CHOP chemotherapy: correlation with PFS and OS		3 years	No