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

This study is currently recruiting participants.
Verified January 2013 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Cheolwon Suh, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01279902
First received: August 3, 2010
Last updated: January 22, 2013
Last verified: January 2013

August 3, 2010
January 22, 2013
August 2010
September 2015   (final data collection date for primary outcome measure)
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 relpase of DLBCL
Disease-free survival at 2 year [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01279902 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    proportion of patients surviving at 2 year after first cycle of R-CHOP chemotheray 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 vesrion 3.0.
  • Overall survival at 2 year [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Abbreviated R-CHOP in Completely Excised Stage I or II DLBCL
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diffuse Large B-cell Lymphoma With Ann-Arbor Stage I or II
Drug: 3 Cycles of 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).
Experimental: 3 Cycles of R-CHOP
3 Cycles of R-CHOP immunochemotherapy
Intervention: Drug: 3 Cycles of Rituximab plus CHOP Immunochemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
23
October 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Cheolwon Suh, MD, Ph D 82-2-3010-3209 csuh@amc.seoul.kr
Korea, Republic of
 
NCT01279902
AMC_NHL01
No
Cheolwon Suh, Asan Medical Center
Asan Medical Center
Not Provided
Principal Investigator: Cheolwon Suh, MD, PhD Asan Mecical Center, University of Ulsan College of Medicine
Asan Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP