Abbreviated R-CHOP in Completely Excised Stage I or II DLBCL

NCT ID: NCT01279902

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2017-01-31

Brief Summary

This study aims; to assess the efficacy of shortened systemic chemotherapy in patients with completely excised CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) with Ann Arbor Stage I or II.

Detailed Description

Unlike the limited stage diffuse Large B-cell Lymphoma (DLBCL) treated with primary chemotherapy followed by radiotherapy, patients with stage I or II DLBCL would be treated with surgical resection followed by chemotherapy in this trial. While chemotherapy is the main treatment modality and radiotherapy becomes adjuvant treatment in the former treatment scheme, surgical resection will remove all the gross lesions and chemotherapy aims to remove all microscopic disease whichever exists in the latter treatment scheme. Currently, six cycles of chemotherapy is usually performed after surgery even without any residual lesion compared with three cycles of chemotherapy in the former treatment scheme which plays primary role in the treatment scheme. The investigators will investigate whether abbreviated 3 cycles of Rituximab Plus Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone (R-CHOP) immunochemotherapy following complete resection is an effective and safe treatment.

Conditions

Diffuse Large B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab plus CHOP Immunochemotherapy

Interventions: conventional R-CHOP every 3 weeks for 3 cycles

• Rituximab 375 mg/M2 IV day 1
• Cyclophosphamide 750 mg/M2 IV day1
• Vincristine 1.5 mg/M2 (max. 2 mg) IV day1
• Prednisolone 50 mg bid day 1-5, every 3 weeks

Group Type: EXPERIMENTAL

Rituximab plus CHOP Immunochemotherapy

Intervention Type: DRUG

The R-CHOP treatment will continue up to 3 cycles with interval of 21 days: Each cycle consists of rituximab 375mg/m2 (iv, on day 1), cyclophosphamide 750 mg/m2 (iv, on day 1), doxorubicin 50mg/m2 (iv, on day 1), vincristine 1.4mg/m2 (iv, on day 1), and prednisolone 100mg (po, on day 1-5).

Interventions

Rituximab plus CHOP Immunochemotherapy

The R-CHOP treatment will continue up to 3 cycles with interval of 21 days: Each cycle consists of rituximab 375mg/m2 (iv, on day 1), cyclophosphamide 750 mg/m2 (iv, on day 1), doxorubicin 50mg/m2 (iv, on day 1), vincristine 1.4mg/m2 (iv, on day 1), and prednisolone 100mg (po, on day 1-5).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who underwent curative resection of primary tumor
• Pathologically confirmed CD20 positive diffuse large B-cell lymphoma (DLBCL) after surgical resection
• Ann Arbor Stage I or II
• No history of chemotherapy
• Performance status: ECOG 0-2
• Age: 18 to 70 years old
• Complete excision with negative resection margin on pathologic report after surgery
• Cardiac ejection fraction ≥ 50% as measured by MUGA or 2D echocardiography without clinically significant abnormalities
• Adequate renal function: serum creatinine level below 2 mg/dL (177μmol/L)
• Adequate liver functions: Transaminase (AST/ALT) < 3X upper normal value, Bilirubin < 2X upper normal value
• Adequate hematologic function: hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500/mm3 and platelet count ≥ 75,000/mm3
• Informed consent

Exclusion Criteria

• Patients with a known history of HIV (+) or HCV (+). However, HBV(+) patients are eligible if primary prophylaxis is given
• Previous or concurrent cancer that is distinct in primary site or histology from DLBCL, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception
• Other serious illness or medical conditions

1. Unstable cardiac disease (i.e. congestive heart failure, arrhythmia symptomatic coronary artery disease) despite treatment, myocardial infarction within 6 months prior to study entry

2. History of significant neurological or psychiatric disorders including dementia or seizures

3. Active uncontrolled infection (viral, bacterial or fungal infection)

4. Other serious medical illnesses

• Known hypersensitivity to any of the study drugs or their ingredients
• Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
• Patient with B symptoms or Bulky disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 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

Principal Investigators

Cheolwon Suh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Mecical Center, University of Ulsan College of Medicine

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

Kang S, Cho H, Sohn BS, Oh SY, Lee WS, Lee SM, Yang DH, Huh J, Yoon DH, Suh C. Long-term follow-up of abbreviated R-CHOP chemoimmunotherapy for completely resected limited-stage diffuse large B cell lymphoma (CISL 12-09). Ann Hematol. 2020 Dec;99(12):2831-2836. doi: 10.1007/s00277-020-04284-z. Epub 2020 Sep 28.

Reference Type: DERIVED

PMID: 32989495 (View on PubMed)

Other Identifiers

AMC_NHL01

Identifier Type: -

Identifier Source: org_study_id