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Trial record 99 of 536 for:    Argentina | Bulgaria

MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

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ClinicalTrials.gov Identifier: NCT00430352
Recruitment Status : Completed
First Posted : February 1, 2007
Results First Posted : June 8, 2015
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Hodgkin's Lymphoma
Intervention Drug: rituximab [MabThera/Rituxan]
Enrollment 545
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab 375 Milligrams Per Square Meter (mg/m^2)
Hide Arm/Group Description Participants received rituximab 375 mg/m^2 intravenously (IV) once every 8 weeks for a total 12 infusions until progression, relapse, start of a new treatment, death, or toxicity.
Period Title: Overall Study
Started 545
Completed 407
Not Completed 138
Reason Not Completed
Disease progression             58
Withdrawal by Subject             11
Adverse Event             16
Death             5
Not specified             48
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
Overall Number of Baseline Participants 545
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population: all participants who completed a baseline visit and at least 1 further assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 545 participants
56.3  (11.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 545 participants
Female
313
  57.4%
Male
232
  42.6%
1.Primary Outcome
Title Percentage of Participants With an Adverse Event (AE) - Overall Summary
Hide Description Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: any participant who received at least 1 dose of study treatment.
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
Overall Number of Participants Analyzed 534
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 67.4
Any infusion-related AE 5.8
Any non-infusion related SAE 20.2
Any infusion-related SAE 0.2
Deaths 7.5
Toxicity as primary cause for discontinuation 3.0
2.Secondary Outcome
Title Progression-Free Survival - Percentage of Participants With an Event
Hide Description PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.
Time Frame Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
Overall Number of Participants Analyzed 545
Measure Type: Number
Unit of Measure: percentage of participants
24.0
3.Secondary Outcome
Title Progression-Free Survival - Time to Event
Hide Description PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.
Time Frame Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
Overall Number of Participants Analyzed 545
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Median and 95 percent (%) confidence interval (CI) for PFS could not be estimated due to the large number of censored participants and the short duration of follow-up.
4.Secondary Outcome
Title Event-Free Survival (EFS) - Percentage of Participants With an Event
Hide Description The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.
Time Frame Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
Overall Number of Participants Analyzed 545
Measure Type: Number
Unit of Measure: percentage of participants
24.4
5.Secondary Outcome
Title Event-Free Survival (EFS) - Time to Event
Hide Description EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.
Time Frame Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
Overall Number of Participants Analyzed 545
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Median and 95% CI for EFS could not be estimated due to the large number of censored participants and the short duration of follow-up.
6.Secondary Outcome
Title Overall Survival (OS) - Percentage of Participants With an Event
Hide Description As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.
Time Frame Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
Overall Number of Participants Analyzed 545
Measure Type: Number
Unit of Measure: percentage of participants
7.3
7.Secondary Outcome
Title Overall Survival (OS) - Time to Event
Hide Description OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.
Time Frame Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
Overall Number of Participants Analyzed 545
Median (95% Confidence Interval)
Unit of Measure: percentage of participants
NA [1] 
(NA to NA)
[1]
Median and 95% CI for OS could not be estimated due to the large number of censored participants and the short duration of follow-up.
8.Secondary Outcome
Title Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event
Hide Description As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.
Time Frame Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
Overall Number of Participants Analyzed 545
Measure Type: Number
Unit of Measure: percentage of participants
17.4
9.Secondary Outcome
Title Time to NLT - Time to Event
Hide Description TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.
Time Frame Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
Overall Number of Participants Analyzed 545
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Median and 95% CI for time to NLT could not be estimated due to the large number of censored participants and the short duration of follow-up.
10.Secondary Outcome
Title Percentage of Participants With Response by Best Response to Study Treatment
Hide Description Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL).
Time Frame Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants who received any study treatment were included in the analysis.
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
Overall Number of Participants Analyzed 545
Measure Type: Number
Unit of Measure: percentage of participants
CR/CRu 2.1
No change 87.5
PD 10.5
11.Secondary Outcome
Title Percentage of Participants With PR Who Converted to CRu
Hide Description Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL.
Time Frame Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with PR to most recent treatment were included in the analysis.
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
Overall Number of Participants Analyzed 161
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.2
(3.0 to 11.1)
Time Frame AEs were collected at up through 12 months after last dose (1 year follow-up).
Adverse Event Reporting Description AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
 
Arm/Group Title Rituximab 375 mg/m^2
Hide Arm/Group Description Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
All-Cause Mortality
Rituximab 375 mg/m^2
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab 375 mg/m^2
Affected / at Risk (%)
Total   109/534 (20.41%) 
Blood and lymphatic system disorders   
Neutropenia * 1  4/534 (0.75%) 
Febrile neutropenia * 1  3/534 (0.56%) 
Idiopathic thrombocytopenic purpura * 1  1/534 (0.19%) 
Cardiac disorders   
Coronary artery disease * 1  2/534 (0.37%) 
Supraventricular tachycardia * 1  2/534 (0.37%) 
Acute coronary syndrome * 1  1/534 (0.19%) 
Acute myocardial infarction * 1  1/534 (0.19%) 
Angina pectoris * 1  1/534 (0.19%) 
Angina unstable * 1  1/534 (0.19%) 
Arrhythmia * 1  1/534 (0.19%) 
Cardiomyopathy * 1  1/534 (0.19%) 
Cardiopulmonary failure * 1  1/534 (0.19%) 
Left ventricular dysfunction * 1  1/534 (0.19%) 
Myocarditis * 1  1/534 (0.19%) 
Palpitation * 1  1/534 (0.19%) 
Eye disorders   
Cataract * 1  1/534 (0.19%) 
Eye haemorrhage * 1  1/534 (0.19%) 
Glaucoma * 1  1/534 (0.19%) 
Gastrointestinal disorders   
Diarrhoea * 1  3/534 (0.56%) 
Abdominal hernia * 1  1/534 (0.19%) 
Abdominal pain * 1  1/534 (0.19%) 
Coeliac disease * 1  1/534 (0.19%) 
Colitis * 1  1/534 (0.19%) 
Enterocolitis * 1  1/534 (0.19%) 
Food poisoning * 1  1/534 (0.19%) 
Gastritis * 1  1/534 (0.19%) 
Gastrointestinal haemorrhage * 1  1/534 (0.19%) 
Gastrointestinal obstruction * 1  1/534 (0.19%) 
Oesophageal varices haemorrhage * 1  1/534 (0.19%) 
Oesophagitis * 1  1/534 (0.19%) 
Pancreatitis * 1  1/534 (0.19%) 
Umbilical hernia * 1  1/534 (0.19%) 
Upper gastrointestinal haemorrhage * 1  1/534 (0.19%) 
General disorders   
Pyrexia * 1  4/534 (0.75%) 
Chest pain * 1  2/534 (0.37%) 
Fatigue * 1  1/534 (0.19%) 
Sudden death * 1  1/534 (0.19%) 
Hepatobiliary disorders   
Biliary colic * 1  1/534 (0.19%) 
Cholangitis * 1  1/534 (0.19%) 
Cholecystitis * 1  1/534 (0.19%) 
Liver disorder * 1  1/534 (0.19%) 
Infections and infestations   
Pneumonia * 1  7/534 (1.31%) 
Appendicitis * 1  3/534 (0.56%) 
Sinusitis * 1  2/534 (0.37%) 
Abdominal abscess * 1  1/534 (0.19%) 
Arthritis bacterial * 1  1/534 (0.19%) 
Aspergilloma * 1  1/534 (0.19%) 
Bronchiolitis * 1  1/534 (0.19%) 
Bronchitis * 1  1/534 (0.19%) 
Cellulitis * 1  1/534 (0.19%) 
Cerebral aspergillosis * 1  1/534 (0.19%) 
Diverticulitis * 1  1/534 (0.19%) 
Gastroenteritis * 1  1/534 (0.19%) 
Groin abscess * 1  1/534 (0.19%) 
Herpes zoster * 1  1/534 (0.19%) 
Meningitis enteroviral * 1  1/534 (0.19%) 
Otitis media * 1  1/534 (0.19%) 
Pneumocystis jiroveci pneumonia * 1  1/534 (0.19%) 
Pulmonary tuberculosis * 1  1/534 (0.19%) 
Respiratory tract infection * 1  1/534 (0.19%) 
Injury, poisoning and procedural complications   
Ankle fracture * 1  1/534 (0.19%) 
Foot fracture * 1  1/534 (0.19%) 
Humerus fracture * 1  1/534 (0.19%) 
Joint dislocation * 1  1/534 (0.19%) 
Multiple fractures * 1  1/534 (0.19%) 
Road traffic accident * 1  1/534 (0.19%) 
Investigations   
Alanine aminotransferase increased * 1  1/534 (0.19%) 
Aspartate aminotransferase increased * 1  1/534 (0.19%) 
Blood lactate dehydrogenase increased * 1  1/534 (0.19%) 
Metabolism and nutrition disorders   
Diabetes mellitus * 1  1/534 (0.19%) 
Hyperglycaemia * 1  1/534 (0.19%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain * 1  2/534 (0.37%) 
Osteoarthritis * 1  2/534 (0.37%) 
Osteonecrosis * 1  2/534 (0.37%) 
Back pain * 1  1/534 (0.19%) 
Bursitis * 1  1/534 (0.19%) 
Intervertebral disc protrusion * 1  1/534 (0.19%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute leukaemia * 1  2/534 (0.37%) 
Prostate cancer * 1  2/534 (0.37%) 
Basal cell carcinoma * 1  1/534 (0.19%) 
Bowen's disease * 1  1/534 (0.19%) 
Metastatic gastric cancer * 1  1/534 (0.19%) 
Osteosarcoma recurrent * 1  1/534 (0.19%) 
Sarcoma * 1  1/534 (0.19%) 
Skin cancer * 1  1/534 (0.19%) 
Uterine leiomyoma * 1  1/534 (0.19%) 
Nervous system disorders   
Cerebrovascular accident - IRR * 1  1/534 (0.19%) 
Cerebral haemorrhage * 1  3/534 (0.56%) 
Cerebral ischaemia * 1  1/534 (0.19%) 
Dizziness * 1  1/534 (0.19%) 
Epilepsy * 1  1/534 (0.19%) 
Ischaemic stroke * 1  1/534 (0.19%) 
Paraplegia * 1  1/534 (0.19%) 
Polyneuropathy * 1  1/534 (0.19%) 
Thalamus haemorrhage * 1  1/534 (0.19%) 
Transient ischaemic attack * 1  1/534 (0.19%) 
Psychiatric disorders   
Depressed mood * 1  1/534 (0.19%) 
Renal and urinary disorders   
Renal failure * 1  1/534 (0.19%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  3/534 (0.56%) 
Pleural effusion * 1  2/534 (0.37%) 
Chronic obstructive pulmonary disease * 1  1/534 (0.19%) 
Hypoventilation * 1  1/534 (0.19%) 
Nasal septum deviation * 1  1/534 (0.19%) 
Pleurisy * 1  1/534 (0.19%) 
Pneumonia aspiration * 1  1/534 (0.19%) 
Pulmonary congestion * 1  1/534 (0.19%) 
Respiratory failure * 1  1/534 (0.19%) 
Skin and subcutaneous tissue disorders   
Eczema * 1  1/534 (0.19%) 
Erythema * 1  1/534 (0.19%) 
Social circumstances   
Pregnancy of partner * 1  1/534 (0.19%) 
Surgical and medical procedures   
Female sterilisation * 1  1/534 (0.19%) 
Finger amputation * 1  1/534 (0.19%) 
Inguinal hernia repair * 1  1/534 (0.19%) 
Small intestinal resection * 1  1/534 (0.19%) 
Vascular disorders   
Jugular vein thrombosis * 1  1/534 (0.19%) 
Vascular occlusion * 1  1/534 (0.19%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab 375 mg/m^2
Affected / at Risk (%)
Total   207/534 (38.76%) 
Gastrointestinal disorders   
Diarrhoea * 1  31/534 (5.81%) 
General disorders   
Fatigue * 1  40/534 (7.49%) 
Pyrexia * 1  27/534 (5.06%) 
Infections and infestations   
Nasopharyngitis * 1  38/534 (7.12%) 
Investigations   
Blood lactate dehydrogenase increased * 1  37/534 (6.93%) 
Neutrophil count decreased * 1  29/534 (5.43%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  35/534 (6.55%) 
Arthralgia * 1  34/534 (6.37%) 
Nervous system disorders   
Headache * 1  31/534 (5.81%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  50/534 (9.36%) 
Vascular disorders   
Hypertension * 1  32/534 (5.99%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.1)
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
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00430352     History of Changes
Other Study ID Numbers: MO19872
First Submitted: January 31, 2007
First Posted: February 1, 2007
Results First Submitted: September 4, 2014
Results First Posted: June 8, 2015
Last Update Posted: August 14, 2017