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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cheolwon Suh, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01279902
First received: August 3, 2010
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Diffuse Large B-cell Lymphoma
Drug: Rituximab plus CHOP Immunochemotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Proportion of patients surviving 2 years after first R-CHOP chemotherapy with no relapse of DLBCL


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: from the first R-CHOP to 1 month after completion of R-CHOP ] [ Designated as safety issue: Yes ]
    The number of patients with adverse events will be measured during R-CHOP chemotherapy according to CTCAE version 3.0.


Enrollment: 32
Study Start Date: August 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279902

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Cheolwon Suh, MD, PhD Asan Mecical Center, University of Ulsan College of Medicine
  More Information

Responsible Party: Cheolwon Suh, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01279902     History of Changes
Other Study ID Numbers: AMC_NHL01 
Study First Received: August 3, 2010
Last Updated: July 25, 2016
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Asan Medical Center:
diffuse large B-cell lymphoma
rituximab
CHOP
abbreviated therapy

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Vincristine
Prednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 28, 2016