Know Cancer

or
forgot password

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


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Diffuse Large B-cell Lymphoma With Ann-Arbor Stage I or II

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Disease-free survival

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Cheolwon Suh, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Mecical Center, University of Ulsan College of Medicine

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

AMC_NHL01

NCT ID:

NCT01279902

Start Date:

August 2010

Completion Date:

October 2015

Related Keywords:

  • Diffuse Large B-cell Lymphoma With Ann-Arbor Stage I or II
  • diffuse large B-cell lymphoma
  • rituximab
  • CHOP
  • abbreviated therapy
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location