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Trial record 1 of 1 for:    N0489
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Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00301821
Recruitment Status : Completed
First Posted : March 13, 2006
Results First Posted : March 24, 2015
Last Update Posted : August 1, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE March 9, 2006
First Posted Date  ICMJE March 13, 2006
Results First Submitted Date  ICMJE March 13, 2015
Results First Posted Date  ICMJE March 24, 2015
Last Update Posted Date August 1, 2016
Study Start Date  ICMJE January 2006
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2015)
Event-free Survival After 12 Months [ Time Frame: From Baseline to 12 months ]
The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00301821 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2015)
  • Overall Survival [ Time Frame: time from study entry to 36 months ]
    Percentage of participants alive at different time points
  • Progression-free Survival (PFS) [ Time Frame: the time from study entry to 36 months ]
    Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
  • Overall Response Rate (ORR) [ Time Frame: Baseline to first 6 cycles of treatment ]
    Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
Official Title  ICMJE A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
Brief Summary RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.
Detailed Description

OBJECTIVES:> Primary>

  • Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma.>
  • Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.>
  • Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen.>
  • Assess the safety of this treatment regimen.> Secondary>
  • Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen.> OUTLINE: This is a multicenter study.> Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.> After completion of study treatment, patients are followed periodically for up to 5 years.> PROJECTED ACCRUAL: A total of 86 patients will be accrued for this study.>
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Biological: epratuzumab
  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: prednisone
  • Drug: vincristine sulfate
Study Arms  ICMJE Experimental: Epratuzumab + Rituximab + CHOP
One arm open label.
Interventions:
  • Biological: epratuzumab
  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: prednisone
  • Drug: vincristine sulfate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2015)
107
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed diffuse large B-cell lymphoma

    • B-cell phenotype (CD20+) as determined by immunohistochemistry (IHC) or flow cytometry
    • Stage II, III, or IV disease
  • CD22+ tumor by IHC*

NOTE: *CD22 status may be determined after study enrollment

  • Measurable disease, defined as at least 1 lesion ≥ 1.5 cm by CT scan or physical exam
  • No relapsed or refractory non-Hodgkin's lymphoma
  • No history of transformed lymphoma
  • No CNS lymphoma

    • CNS symptoms or bone marrow or sinus involvement must have absence of CNS lymphoma confirmed by lumbar puncture

PATIENT CHARACTERISTICS:

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3

    - For patients with ECOG PS 3, the PS must be disease related

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Total bilirubin ≤ 2 mg/dL (if total bilirubin > 2 mg/dL, direct bilirubin should be within normal limits)
  • AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if there is liver involvement)
  • Creatinine ≤ 2 times ULN
  • Life expectancy ≥ 12 weeks
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 12 months after completion of study treatment
  • No active serious infection requiring antibiotics
  • No New York Heart Association class III or IV heart disease
  • No other primary malignancy within the past 5 years, except for squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or previously treated prostate cancer with a stable prostate-specific antigen
  • No known HIV positivity
  • No known hepatitis B or C infection
  • Ejection fraction ≥ 45% by MUGA or echocardiogram (required if patients has a history of heart disease or is ≥ 50 years old)
  • Willing to provide blood and tissue samples for mandatory translational research component of study

PRIOR CONCURRENT THERAPY:

  • No prior therapy for diffuse large B-cell lymphoma, including the following:

    • Chemotherapy
    • Immunotherapy
    • Biologic therapy
    • Radiotherapy
  • Prior short course (≤ 14 days) of corticosteroids allowed
  • Prior splenectomy allowed
  • No prior pelvic irradiation
  • No other concurrent investigational agents
  • No concurrent chemotherapy, immunotherapy, or radiotherapy
  • No concurrent enrollment on another treatment study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00301821
Other Study ID Numbers  ICMJE NCCTG-N0489
NCI-2012-02685 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000459932 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Ivana Micallef, MD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2016

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