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

Primary Purpose

Diffuse Large B-cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Rituximab plus CHOP Immunochemotherapy

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring diffuse large B-cell lymphoma, rituximab, CHOP, abbreviated therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab plus CHOP Immunochemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Disease-free survival

Proportion of patients surviving 2 years after first R-CHOP chemotherapy with no relapse of DLBCL

Secondary Outcome Measures

Overall survival

proportion of patients surviving at 2 year after first cycle of R-CHOP chemotherapy regardless of relapse of DLBCL

any adverse events as a measure of safety and tolerability

The number of patients with adverse events will be measured during R-CHOP chemotherapy according to CTCAE version 3.0.

Full Information

NCT ID

NCT01279902

First Posted

August 3, 2010

Last Updated

July 25, 2016

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01279902

Brief Title

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

Official Title

Phase 2 Study of Abbreviated 3 Cycles of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised Stage I or II CD20+ Diffuse Large B-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2010 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B-cell Lymphoma

Keywords

diffuse large B-cell lymphoma, rituximab, CHOP, abbreviated therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rituximab plus CHOP Immunochemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Rituximab plus CHOP Immunochemotherapy

Intervention Description

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).

Primary Outcome Measure Information:

Title

Disease-free survival

Description

Proportion of patients surviving 2 years after first R-CHOP chemotherapy with no relapse of DLBCL

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

proportion of patients surviving at 2 year after first cycle of R-CHOP chemotherapy regardless of relapse of DLBCL

Time Frame

2 years

Title

any adverse events as a measure of safety and tolerability

Description

The number of patients with adverse events will be measured during R-CHOP chemotherapy according to CTCAE version 3.0.

Time Frame

from the first R-CHOP to 1 month after completion of R-CHOP

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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 Unstable cardiac disease (i.e. congestive heart failure, arrhythmia symptomatic coronary artery 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cheolwon Suh, MD, PhD

Organizational Affiliation

Asan Mecical Center, University of Ulsan College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32989495

Citation

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.

Results Reference

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

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