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A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.

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ClinicalTrials.gov Identifier: NCT00517699
Recruitment Status : Terminated (Study was terminated early due to lack of enrollment.)
First Posted : August 17, 2007
Results First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE August 16, 2007
First Posted Date  ICMJE August 17, 2007
Results First Submitted Date  ICMJE June 9, 2014
Results First Posted Date  ICMJE August 8, 2014
Last Update Posted Date August 8, 2014
Study Start Date  ICMJE September 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
  • Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu) [ Time Frame: Week 24 ]
    CR: complete disappearance of all enhancing abnormalities on contrast-enhanced cranial magnetic resonance imaging (MRI); no evidence of active ocular lymphoma as defined by absence of cells in the vitreous and resolution of any previously documented retinal or optic nerve infiltrates; negative cerebrospinal fluid (CSF) cytology; at the time of CR determination, participant had discontinued use of all corticosteroids for at least 2 weeks. CRu requires fulfillment of CR criteria but with these limitations: Fulfills CR criteria but had continued requirement for corticosteroid therapy at any dose; small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; persistent minor abnormality on follow-up ophthalmologic exam (related to persistent non-malignant cells in vitreous, or alterations in retina/optic nerve not consistent with tumor infiltration) if the abnormality is unlikely to represent ocular lymphoma.
  • Percentage of Participants With a CR, CRu or Partial Response (PR) [ Time Frame: Week 24 ]
    PR: greater than or equal to (≥) 50 percent (%) decrease in the contrast-enhancing lesion seen on MRI as compared with the baseline images; (2) Corticosteroid dose was irrelevant to the determination of PR; for participants with ocular disease, ophthalmologic exam must show a decrease in vitreous cell count or retina/optic nerve cellular infiltrate but may have continued to show persistent malignant or suspicious cells; for participants with CSF positive for neoplastic cells, CSF cytology may be negative or continue to show persistent malignant or suspicious cells in patients with ≥50% decrease in the primary brain lesions; no new sites of disease.
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2007)
Complete response rate; overall response rate.
Change History Complete list of historical versions of study NCT00517699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
  • Percentage of Participants With Initial CR or CRu and Subsequent Disease Relapse [ Time Frame: Week 24 ]
  • Overall Survival [ Time Frame: Time of last follow-up assessment between Day 1 and 3 years ]
    Time from entry into trial until death of any cause. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the baseline date.
  • Progression-Free Survival (PFS) [ Time Frame: Week 24 ]
    PFS was defined as the time interval between the entry into trial and occurrence of one of the following events: progression of disease (PD) or death as a result of primary central nervous system lymphoma (PCNSL). Participants who were withdrawn from the study without documented progression and for whom there existed case report form (CRF) evidence that evaluations had been made, were censored at the date of last tumor assessment when participant was known to be progression free. Participants without postbaseline tumor assessments but known to be alive were censored at the time of randomization. PD required a ≥25% increase in the contrast-enhanced lesion seen on MRI as compared with baseline or best response (comparison should be made to the smallest of multiple lesions); progression of ocular disease as indicated by an increase in vitreous cell count or progressive retinal or optic nerve infiltration, appearance of any new lesion or site of disease during or at the end of therapy.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2007)
Efficacy: Overall survival, progression-free survival, relapse rate. Safety: AEs, laboratory parameters.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.
Official Title  ICMJE An Open Label Study of the Effect of Rituxan, High Dose Methotrexate and High Dose Cytarabine on Response Rate in Patients With Primary Central Nervous System Lymphoma.
Brief Summary This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Detailed Description Not Provided
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
  • Drug: rituximab [MabThera/Rituxan]
    750mg/m2 iv
  • Drug: Methotrexate
    8g/m2 iv
  • Drug: Cytarabine
    2g/m2 iv
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: rituximab [MabThera/Rituxan]
  • Drug: Methotrexate
  • Drug: Cytarabine
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 Terminated
Actual Enrollment  ICMJE
 (submitted: July 15, 2009)
5
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, 18-80 years of age;
  • histological diagnosis of primary central nervous system lymphoma;
  • B-cell proliferation verified by positive staining for CD20;
  • >=1 measurable lesion.

Exclusion Criteria:

  • prior chemotherapy, other than corticosteroids, >=6 weeks before and after diagnosis or surgery;
  • history of prior cranial irradiation;
  • evidence of plurisystemic non-Hodgkin's lymphoma;
  • other active malignant disease (other than basal cell or squamous cell cancer of skin,or cancer in situ of cervix;
  • uncontrolled active infection.
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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00517699
Other Study ID Numbers  ICMJE ML19652
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2014

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