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

July 25, 2016 updated by: Cheolwon Suh, Asan Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 2 years
Proportion of patients surviving 2 years after first R-CHOP chemotherapy with no relapse of DLBCL
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
proportion of patients surviving at 2 year after first cycle of R-CHOP chemotherapy regardless of relapse of DLBCL
2 years
any adverse events as a measure of safety and tolerability
Time Frame: from the first R-CHOP to 1 month after completion of R-CHOP
The number of patients with adverse events will be measured during R-CHOP chemotherapy according to CTCAE version 3.0.
from the first R-CHOP to 1 month after completion of R-CHOP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Cheolwon Suh, MD, PhD, Asan Mecical Center, University of Ulsan College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

January 1, 2017

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

January 19, 2011

First Posted (ESTIMATE)

January 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC_NHL01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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