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NCT00517699 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2014-08-08

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)

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outcome · POSTED

Percentage of Participants With a CR, CRu or Partial Response (PR)

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outcome · POSTED

Percentage of Participants With Initial CR or CRu and Subsequent Disease Relapse

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression-Free Survival (PFS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: rituximab [MabThera/Rituxan]
    2. Drug: Methotrexate
    3. Drug: Cytarabine
    label
    1
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. 1
    description
    750mg/m2 iv
    name
    rituximab [MabThera/Rituxan]
    type
    DRUG
  2. arm Group Labels
    1. 1
    description
    8g/m2 iv
    name
    Methotrexate
    type
    DRUG
  3. arm Group Labels
    1. 1
    description
    2g/m2 iv
    name
    Cytarabine
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
5
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)
    time Frame
    Week 24
  2. description
    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.
    measure
    Percentage of Participants With a CR, CRu or Partial Response (PR)
    time Frame
    Week 24
secondary Outcomes
  1. measure
    Percentage of Participants With Initial CR or CRu and Subsequent Disease Relapse
    time Frame
    Week 24
  2. description
    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.
    measure
    Overall Survival
    time Frame
    Time of last follow-up assessment between Day 1 and 3 years
  3. description
    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.
    measure
    Progression-Free Survival (PFS)
    time Frame
    Week 24
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-bfa8160c91727532b270
      requested nct id
      NCT00517699
      primary nct id
      NCT00517699
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      5133d5efc2041fb2554b035b378f2db0c15cad34dada88cd170d20b9c4e7432a
      payload sha256
      cfb137391a91cd4911aef23e0daf28a2279d107e6f568d1f55952d23876cb498
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-bfa8160c91727532b270
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00517699
      occurrences
      1. context exact
        NCT00517699
        end
        11
        exact text
        NCT00517699
        start
        0
      offset unit
      unicode_code_points
      query cond
      Primary Central Nervous System Lymphoma
      query disease state id
      ds-primary-central-nervous-system-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-primary-central-nervous-system-lymphoma-000.json
      source file sha256
      5133d5efc2041fb2554b035b378f2db0c15cad34dada88cd170d20b9c4e7432a
      source json pointer
      /studies/42/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      58c7abecbf080e7690c7c1fe8022bff2b7e0fa4e7c59dc84bb89da5766c17046

    Preserved source evidence · Not medical advice