Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 40 of 156 for:    "Primary Central Nervous System Lymphoma"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Drug: rituximab [MabThera/Rituxan]
Drug: Methotrexate
Drug: Cytarabine
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab, Cytarabine, and Methotrexate (MTX)
Hide Arm/Group Description Participants received single doses of rituximab 750 milligrams per square meter (mg/m^2) intravenously (IV) at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 grams per square meter (g/m^2) IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
Period Title: Overall Study
Started 5
Completed 0
Not Completed 5
Reason Not Completed
Withdrawal by Subject             1
Lack of Efficacy             1
Administrative error             1
Study terminated by Sponsor             2
Arm/Group Title Rituximab, Cytarabine, and MTX
Hide Arm/Group Description Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
Safety population: all participants who received any amount of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
59.8  (8.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
1.Primary Outcome
Title Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)
Hide 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.
Arm/Group Title Rituximab, Cytarabine, and MTX
Hide Arm/Group Description:
Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Percentage of Participants With a CR, CRu or Partial Response (PR)
Hide 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.
Arm/Group Title Rituximab, Cytarabine, and MTX
Hide Arm/Group Description:
Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Participants With Initial CR or CRu and Subsequent Disease Relapse
Hide Description [Not Specified]
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.
Arm/Group Title Rituximab, Cytarabine, and MTX
Hide Arm/Group Description:
Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Survival
Hide 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.
Time Frame Time of last follow-up assessment between Day 1 and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.
Arm/Group Title Rituximab, Cytarabine, and MTX
Hide Arm/Group Description:
Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.
Arm/Group Title Rituximab, Cytarabine, and MTX
Hide Arm/Group Description:
Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline up to 24 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab, Cytarabine, and MTX
Hide Arm/Group Description Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
All-Cause Mortality
Rituximab, Cytarabine, and MTX
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab, Cytarabine, and MTX
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituximab, Cytarabine, and MTX
Affected / at Risk (%)
Total   5/5 (100.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/5 (20.00%) 
Leukopenia * 1  1/5 (20.00%) 
Neutropenia * 1  4/5 (80.00%) 
Thrombocytopenia * 1  1/5 (20.00%) 
Eye disorders   
Eye allergy * 1  1/5 (20.00%) 
Gastrointestinal disorders   
Abdominal pain * 1  2/5 (40.00%) 
Constipation * 1  3/5 (60.00%) 
Diarrhoea * 1  1/5 (20.00%) 
Dyspepsia * 1  1/5 (20.00%) 
Gingival pain * 1  1/5 (20.00%) 
Nausea * 1  3/5 (60.00%) 
Vomiting * 1  2/5 (40.00%) 
General disorders   
Fatigue * 1  3/5 (60.00%) 
Generalised oedema * 1  2/5 (40.00%) 
Hyperthermia * 1  3/5 (60.00%) 
Injection site erythema * 1  1/5 (20.00%) 
Injection site pain * 1  1/5 (20.00%) 
Non-cardiac chest pain * 1  1/5 (20.00%) 
Oedema peripheral * 1  3/5 (60.00%) 
Pain * 1  1/5 (20.00%) 
Vessel puncture site bruise * 1  1/5 (20.00%) 
Hepatobiliary disorders   
Hepatitis * 1  1/5 (20.00%) 
Infections and infestations   
Conjunctivitis bacterial * 1  1/5 (20.00%) 
Herpes zoster * 1  1/5 (20.00%) 
Upper respiratory tract infection * 1  2/5 (40.00%) 
Urinary tract infection * 1  1/5 (20.00%) 
Injury, poisoning and procedural complications   
Drug toxicity * 1  3/5 (60.00%) 
Skin laceration * 1  1/5 (20.00%) 
Wound * 1  1/5 (20.00%) 
Investigations   
Creatinine renal clearance decreased * 1  1/5 (20.00%) 
Hepatic enzyme abnormal * 1  1/5 (20.00%) 
Hepatic enzyme increased * 1  2/5 (40.00%) 
Weight increased * 1  1/5 (20.00%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  1/5 (20.00%) 
Electrolyte imbalance * 1  1/5 (20.00%) 
Hypernatraemia * 1  1/5 (20.00%) 
Hypokalaemia * 1  5/5 (100.00%) 
Malnutrition * 1  1/5 (20.00%) 
Musculoskeletal and connective tissue disorders   
Mobility decreased * 1  1/5 (20.00%) 
Muscular weakness * 1  1/5 (20.00%) 
Myalgia * 1  1/5 (20.00%) 
Nervous system disorders   
Dementia * 1  1/5 (20.00%) 
Dysgeusia * 1  1/5 (20.00%) 
Headache * 1  3/5 (60.00%) 
Loss of consciousness * 1  1/5 (20.00%) 
Neurological symptom * 1  1/5 (20.00%) 
Somnolence * 1  1/5 (20.00%) 
Psychiatric disorders   
Agitation * 1  1/5 (20.00%) 
Anxiety * 1  2/5 (40.00%) 
Confusional state * 1  1/5 (20.00%) 
Insomnia * 1  1/5 (20.00%) 
Mood altered * 1  1/5 (20.00%) 
Renal and urinary disorders   
Renal cyst * 1  1/5 (20.00%) 
Renal failure * 1  1/5 (20.00%) 
Urinary incontinence * 1  1/5 (20.00%) 
Urinary retention * 1  1/5 (20.00%) 
Reproductive system and breast disorders   
Erectile dysfunction * 1  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  1/5 (20.00%) 
Pharyngolaryngeal pain * 1  1/5 (20.00%) 
Rales * 1  1/5 (20.00%) 
Respiratory distress * 1  1/5 (20.00%) 
Upper respiratory tract congestion * 1  1/5 (20.00%) 
Skin and subcutaneous tissue disorders   
Dermatitis * 1  1/5 (20.00%) 
Dermatitis contact * 1  1/5 (20.00%) 
Erythema * 1  2/5 (40.00%) 
Hyperhidrosis * 1  1/5 (20.00%) 
Pruritus * 1  1/5 (20.00%) 
Rash * 1  1/5 (20.00%) 
Skin burning sensation * 1  1/5 (20.00%) 
Vascular disorders   
Arterial thrombosis limb * 1  1/5 (20.00%) 
Flushing * 1  1/5 (20.00%) 
Hot flush * 1  1/5 (20.00%) 
Hypertension * 1  2/5 (40.00%) 
Hypotension * 1  1/5 (20.00%) 
Venous thrombosis limb * 1  1/5 (20.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
The study was terminated early due to lack of enrollment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517699     History of Changes
Other Study ID Numbers: ML19652
First Submitted: August 16, 2007
First Posted: August 17, 2007
Results First Submitted: June 9, 2014
Results First Posted: August 8, 2014
Last Update Posted: August 8, 2014