Abbreviated R-CHOP in Completely Excised Stage I DLBCL

This study is currently recruiting participants.
Verified January 2012 by Asan Medical Center

First Received on August 3, 2010.  
Last Updated on January 19, 2012  
History of Changes
This Clinical Trial Sponsored By: Asan Medical Center
Information provided by (Responsible Party): Cheolwon Suh, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01279902
 

Purpose for Clinical Trial

Unlike the limited stage diffuse Large B-cell Lymphoma (DLBCL) treated with primary chemotherapy followed by radiotherapy, patients with stage I 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.

Condition Study Intervention
Diffuse Large B-cell Lymphoma Drug: 3 Cycles of Rituximab plus CHOP Immunochemotherapy

Study Type: Study Interventional
Study Design: Endpoint Classification: Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploratory Study of Abbreviated 3 Cycles of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised Stage I CD20+ Diffuse Large B-cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Cyclophosphamide
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone Sodium Phosphate
Prednisolone phosphate
Methylprednisolone Sodium Succinate
Rituximab

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures For Clinical Trial:

  • 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

Secondary Outcome Measures For Clinical Trial:

  • 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 4.0.

Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Study Intervention Details:

    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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
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
  • 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

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