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Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00690560
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne

Tracking Information
First Submitted Date  ICMJE June 3, 2008
First Posted Date  ICMJE June 4, 2008
Last Update Posted Date February 10, 2015
Study Start Date  ICMJE May 2007
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2015)
Event-free survival [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
Event-free survival
Change History Complete list of historical versions of study NCT00690560 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2015)
  • Overall survival [ Time Frame: up to one year ]
  • Relapse-free survival in responding patients [ Time Frame: up to one year ]
  • Rate of disease progression [ Time Frame: up to 2 years ]
  • Response rate [ Time Frame: up to six months ]
  • Toxicities [ Time Frame: up to 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
  • Overall survival
  • Relapse-free survival in responding patients
  • Rate of disease progression
  • Response rate
  • Toxicities
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma
Official Title  ICMJE International Phase II Study Evaluating the Association of CHOP-rituximab With Consolidation by Early Ibritumomab Tiuxetan-Y90 in Patients Aged 65 to 80 Years With CD20+ Large Cell Malignant Lymphoma and no Prior Therapy
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may be effective in treating cancer and blocking the body's immune response. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, 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. Giving chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving doxorubicin together with vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell lymphoma.

Detailed Description

OBJECTIVES:

Primary

  • Determine event-free survival of patients with large B-cell lymphoma treated with CHOP-R followed by consolidation therapy.

Secondary

  • Determine overall survival.
  • Evaluate relapse-free survival for patients achieving complete or partial response.
  • Determine the rate of disease progression.
  • Determine response rate at the end of study therapy.
  • Assess the toxicities of this regimen.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive the CHOP-R regimen comprising doxorubicin hydrochloride IV, vincristine IV, cyclophosphamide IV, and rituximab IV on day 1 and prednisone IV on days 1-5. Treatment repeats every 2 weeks for 2 courses.

Patients who achieve complete or partial response, as assessed by PET/CT scan, receive a third course of induction therapy.

  • Consolidation therapy: Patients receive rituximab IV on days -8 to 0 and yttrium Y 90 ibritumomab tiuxetan IV on day 0.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: prednisone
  • Drug: vincristine sulfate
  • Radiation: yttrium Y 90 ibritumomab tiuxetan
Study Arms  ICMJE Experimental: R-CHOP14 chemotherapy
Interventions:
  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: prednisone
  • Drug: vincristine sulfate
  • Radiation: yttrium Y 90 ibritumomab tiuxetan
Publications * Not Provided

*   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: February 8, 2015)
30
Original Enrollment  ICMJE
 (submitted: June 3, 2008)
63
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed large B-cell lymphoma

    • Stage I, II, III, or IV disease
    • Bone marrow or lymph node involvement by small cell lymphoma allowed
    • No serious, progressive pathology (at investigator's discretion)
  • CD20-positive disease
  • Measurable disease
  • No prior indolent lymphoma, treated or not
  • No meningeal or CNS lymphoma

PATIENT CHARACTERISTICS:

  • International prognostic index < 2 (adjusted for age)
  • Life expectancy > 3 months
  • ALT and AST ≤ 2.5 times upper limit of normal
  • Bilirubin ≤ 30 mmol/L
  • Creatinine ≤ 150 μmol/L
  • HIV, hepatitis B virus, and hepatitis C virus negative (unless after vaccine)
  • No contraindication to chemotherapy or immunotherapy
  • No cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No contraindication to a venous catheter

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 30 days since prior and no other concurrent investigational treatment
  • No prior therapy
  • No concurrent participation in another clinical study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690560
Other Study ID Numbers  ICMJE CDR0000589530
CALACASS-3RCHOPZ
INCA-RECF0624
EUDRACT-2006-006179-19
CALACASS-2006/27
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Antoine Lacassagne
Study Sponsor  ICMJE Centre Antoine Lacassagne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Frederec Peyrade, MD Centre Antoine Lacassagne
PRS Account Centre Antoine Lacassagne
Verification Date February 2015

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