Clinical Trial Results:
A Randomised Study to Investigate the Efficacy of Bendamustine in Subjects with Indolent Non-Hodgkin’s Lymphoma (NHL) Refractory to Rituximab
Summary
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EudraCT number |
2010-022102-41 |
Trial protocol |
SK ES IT PT PL |
Global end of trial date |
31 Jul 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Aug 2019
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First version publication date |
07 Aug 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BDM3502
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Mundipharma Research Ltd.
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Sponsor organisation address |
194-198 Cambridge Science Park, Cambridge, United Kingdom, CB4 0AB
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Public contact |
Clinical Operations, Mundipharma Research Ltd., +44 1223 424900, info@contact-clinical-trials.com
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Scientific contact |
Clinical Operations, Mundipharma Research Ltd., +44 1223 424900, info@contact-clinical-trials.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Jul 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Jul 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Jul 2018
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The main objective of the study was to compare the efficacy of bendamustine against treatment of physician’s choice (TPC) on progression free survival (PFS) in subjects with indolent B-cell in Non-Hodgkin’s Lymphoma (NHL) that did not respond (stable disease [SD] or progressive disease [PD]) to rituximab or a rituximab containing regimen during or within 6 months of the previous rituximab treatment.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
Medications to treat nausea and vomiting or acquired infections during the study were allowed. Blood products and growth factors were allowed at the discretion of the Investigator. | ||
Evidence for comparator |
Treatment in the reference arm was Treatment of Physician’s Choice (TPC) which was defined as any cancer specific therapy, or best supportive care. Treatment was given according to the label and based upon local institutional medical practice and clinical judgement. Treatment was experimental in nature. The use of bendamustine was not permitted during the Treatment Phase. | ||
Actual start date of recruitment |
04 Nov 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 3
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Country: Number of subjects enrolled |
Portugal: 9
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Country: Number of subjects enrolled |
Slovakia: 1
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Country: Number of subjects enrolled |
Spain: 5
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Country: Number of subjects enrolled |
Australia: 91
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Worldwide total number of subjects |
109
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EEA total number of subjects |
18
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
48
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From 65 to 84 years |
59
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85 years and over |
2
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Recruitment
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Recruitment details |
The study was conducted at 25 centers in 5 countries. | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 109 subjects were enrolled into this study, of which 21 subjects were screen failures (21 due to Non-compliance; 1 due to Subject's choice and 2 due to Other reason). Out of the 88 subjects randomised, 54 subjects completed and 31 subjects discontinued the study due to Adverse Events (21), Administrative (1) and Disease Progression (9). | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Period
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Bendamustine | ||||||||||||||||||||||||
Arm description |
Subjects received intravenously (IV) bendamustine 120 milligram per meter square (mg/m^2) on Days 1 and 2, every 21 days up to 6 cycles. However, if a subject was receiving clinical benefit after 6 cycles then a further 2 cycles of bendamustine were administered. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Bendamustine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subjects received intravenously bendamustine 120 mg/m^2
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Arm title
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Treatment of Physician’s Choice (TPC) | ||||||||||||||||||||||||
Arm description |
Subjects received treatment of physician’s choice which is defined as any cancer specific therapy, or best supportive care. Treatment was given according to the label and based upon local institutional medical practice and clinical judgement. Treatment was not experimental in nature. Bendamustine treatment was not permitted as TPC in the treatment phase. | ||||||||||||||||||||||||
Arm type |
TPC | ||||||||||||||||||||||||
Investigational medicinal product name |
Multiple cancer specific therapy
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for concentrate and solution for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Variable treatment was given according to the label and based upon local institutional medical practice and clinical judgement.
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: A total of 109 subjects were enrolled into this study, of which 21 subjects were screen failures and only 88 subjects randomized. |
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Baseline characteristics reporting groups
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Reporting group title |
Bendamustine
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Reporting group description |
Subjects received intravenously (IV) bendamustine 120 milligram per meter square (mg/m^2) on Days 1 and 2, every 21 days up to 6 cycles. However, if a subject was receiving clinical benefit after 6 cycles then a further 2 cycles of bendamustine were administered. | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment of Physician’s Choice (TPC)
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Reporting group description |
Subjects received treatment of physician’s choice which is defined as any cancer specific therapy, or best supportive care. Treatment was given according to the label and based upon local institutional medical practice and clinical judgement. Treatment was not experimental in nature. Bendamustine treatment was not permitted as TPC in the treatment phase. | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Bendamustine
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Reporting group description |
Subjects received intravenously (IV) bendamustine 120 milligram per meter square (mg/m^2) on Days 1 and 2, every 21 days up to 6 cycles. However, if a subject was receiving clinical benefit after 6 cycles then a further 2 cycles of bendamustine were administered. | ||
Reporting group title |
Treatment of Physician’s Choice (TPC)
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Reporting group description |
Subjects received treatment of physician’s choice which is defined as any cancer specific therapy, or best supportive care. Treatment was given according to the label and based upon local institutional medical practice and clinical judgement. Treatment was not experimental in nature. Bendamustine treatment was not permitted as TPC in the treatment phase. |
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End point title |
Progression Free Survival (PFS) | ||||||||||||
End point description |
PFS is defined as time from randomization until disease progression or death due to any cause. For subjects who did not have an event (that is those who were lost to follow-up or who had not progressed at the date of data cut-off), PFS was censored. That is: PFS (days) = Date of progression/death/censoring – Date of randomization + 1. Subjects who did not progress in their disease were censored on the date of their last confirmed assessment. The Intent-to treat (ITT) population included all the subjects who were randomized irrespective of whether or not they actually received medication.
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End point type |
Primary
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End point timeframe |
From Day 1 up to end of the study (Approximately up to 7.5 years); Follow up was done every 6 months and 3 months for subjects with and without disease progression respectively.
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Statistical analysis title |
Statistical Analysis 1 | ||||||||||||
Comparison groups |
Bendamustine v Treatment of Physician’s Choice (TPC)
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Number of subjects included in analysis |
88
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.297 | ||||||||||||
Method |
Log-Rank test | ||||||||||||
Parameter type |
Hazard ratio (HR) | ||||||||||||
Point estimate |
0.752
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.403 | ||||||||||||
upper limit |
1.403 |
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End point title |
Percentage of Subjects with Overall Response Rate (ORR) | |||||||||||||||||||||||||||
End point description |
ORR is defined as Percentage of subjects who confirmed Complete Remission (CR) or Partial Remission (PR) called as responders. Non-responders included subjects with stable disease (SD) or progressive disease (PD). CR is defined as complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy; all lymph nodes and nodal masses must have regressed on computed tomography (CT) to normal size (less than or equal to [<=] 1.5 centimeter [cm] in their greatest transverse diameter for nodes greater than [>] 1.5 cm before therapy). PR is defined as least a 50% decrease in the sum of product of the diameters (SPD) of up to six of largest dominant nodes or nodal masses. A subject was considered to have SD when he or she failed to attain the criteria needed for a CR or PR, but did not fulfill those for PD. The ITT population comprised of all subjects who were randomised irrespective of whether or not they actually received medication.
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End point type |
Secondary
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End point timeframe |
From Day 1 up to end of the study (Approximately up to 7.5 years)
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No statistical analyses for this end point |
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End point title |
Duration of Response (DR) | ||||||||||||
End point description |
DR is defined as time from initial response (CR/PR) to progression or death. Where CR is defined as complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy; all lymph nodes and nodal masses must have regressed on CT to normal size (<= 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy). PR is defined as least a 50% decrease in the sum of product of the diameters of up to six of largest dominant nodes or nodal masses. A subject was considered to have SD when he or she failed to attain the criteria needed for a CR or PR, but did not fulfill those for PD. The ITT population comprised of all subjects who were randomised irrespective of whether or not they actually received medication. Here '99999' signifies not estimable as upper bound not reached.
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End point type |
Secondary
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End point timeframe |
From Day 1 up to end of the study (Approximately up to 7.5 years)
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No statistical analyses for this end point |
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End point title |
Overall Survival (OS) | ||||||||||||
End point description |
OS is defined as time from randomization to death. The ITT population comprised of all subjects who were randomized irrespective of whether or not they actually received medication. Here '99999' in median signifies not estimable median survival time cannot be estimated because this group did not reached at the analysis cut off (survival was greater than 50% in the TPC group at the time of the last analysis), while '99999' in upper bound signifies not estimable as upper bound not reached.
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End point type |
Secondary
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End point timeframe |
From Day 1 up to end of the study (Approximately up to 7.5 years)
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No statistical analyses for this end point |
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End point title |
Number of Subjects with Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events | ||||||||||||||||||||||||||||||
End point description |
An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, including placebo, and which did not necessarily have to have had a causal relationship with treatment. An SAE is any untoward medical occurrence that at any dose that resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. TEAEs are defined as new or worsening adverse events with an onset date occurring on or after first dose date of study medication inclusive to 30 days post-last dose. The Safety Population included all subjects who were randomized and who received at least 1 dose of study treatment. Here, 'Number of subjects analysed' signifies the subjects evaluable for this population.
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End point type |
Secondary
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End point timeframe |
From Day 1 of treatment administration up to 30 days after last treatment
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Health Related Quality of Life (HRQL) as Assessed by EuroQol Group (EQ-5D) | ||||||||||||||||||||||||
End point description |
EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a visual analog scale (VAS). Each dimension has 3 levels: No problems, Some problems, Severe problems. Responses to the single dimensions will be coded numerically 1 to 3 in order of decreasing health status. Responses to the EQ-5D will be converted into an EQ-5D index, which provides a single summary by weighting the response levels in each dimension . The weighted index constitutes a measure of utility and represents a health state from 0 to 1, where 1 is fullest health. This index will be derived only from patients who have provided a complete 5- response profile. The EQ VAS records the subject’s self–rated health where the endpoints are worst imaginable health (score=0) to best imaginable health (score =100). Here 'n' signifies number of subjects analysed for category at specified time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 63 and Day 126
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Health Related Quality of Life as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Version 3.0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
EORTC QLQ-C30 v3 is composed of 2 multi-item scales and single-item measures,: 1) Global scale: health status/quality of life (QoL) 2) Functional scales: physical/role/emotional/cognitive/social; 3) Symptom scales: fatigue/nausea/vomiting/pain/dyspnoea/insomnia/appetite loss/constipation/diarrhoea/financial impact. Global health status/ QoL questions are rated from very poor - excellent on scale of 1-7. All other questions are rated as not at all/a little/quite a bit/very much, coded from 1-4 in decreasing order health status. Each multi-item scales includes a different set of items - with no item repetition. All scales are transformed to have scores ranging from 0-100. High score for functional scale represents high/healthy functioning level, high score for global health status /QoL represents high QoL but high score for a symptom scale/item represents a high level of symptomatology/ problem. Here 'n' signifies number of subjects analysed for category at specified time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 63 and Day 126
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From Day 1 of treatment administration up to 30 days after last treatment.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.1
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Reporting groups
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Reporting group title |
Bendamustine
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Reporting group description |
Subjects received intravenously (IV) bendamustine 120 milligram per meter square (mg/m^2) on Days 1 and 2, every 21 days up to 6 cycles. However, if a subject was receiving clinical benefit after 6 cycles then a further 2 cycles of bendamustine were administered. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment of Physician’s Choice (TPC)
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Reporting group description |
Subjects received treatment of physician’s choice which is defined as any cancer specific therapy, or best supportive care. Treatment was given according to the label and based upon local institutional medical practice and clinical judgement. Treatment was not experimental in nature. Bendamustine treatment was not permitted as TPC in the treatment phase. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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08 Apr 2011 |
The overall reason of this amendment was to update study design methodology. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
The study did not achieve the recruitment goal and was therefore terminated early. |