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Trial record 49 of 314 for:    BENDAMUSTINE

Bendamustine Hydrochloride (HCl) in Indolent Non-Hodgkin's Lymphoma That Has Progressed During or Following Treatment With a Rituximab Regimen or Previously Untreated Chronic Lymphocytic Leukemia (BENDACT)

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: NCT01500083
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : October 16, 2014
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Lundbeck Canada Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Indolent Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Interventions Drug: Bendamustine at a dose of 100 mg/m2
Drug: Bendamustine at a dose of 120 mg/m2
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients With Previously Untreated CLL Patients With iNHL
Hide Arm/Group Description Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes. Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
Period Title: Overall Study
Started 16 74
Completed 4 31
Not Completed 12 43
Reason Not Completed
Adverse Event             4             17
Death             0             2
Lost to Follow-up             1             0
Withdrawal of Consent             0             1
Disease Progression             2             10
Investigator Discretion             3             8
Other Reasons             2             5
Arm/Group Title Patients With Previously Untreated CLL Patients With iNHL Total
Hide Arm/Group Description Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes. Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes. Total of all reporting groups
Overall Number of Baseline Participants 16 74 90
Hide Baseline Analysis Population Description
all-patients-treated set (APTS): all enrolled patients who took at least one dose of investigational medicinal product (IMP)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 74 participants 90 participants
69.3  (7.12) 63.1  (10.84) 64.2  (10.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 74 participants 90 participants
Female
9
  56.3%
35
  47.3%
44
  48.9%
Male
7
  43.8%
39
  52.7%
46
  51.1%
1.Primary Outcome
Title Number of Adverse Events
Hide Description [Not Specified]
Time Frame Up to 266 days
Hide Outcome Measure Data
Hide Analysis Population Description
APTS
Arm/Group Title Patients With Previously Untreated CLL Patients With iNHL
Hide Arm/Group Description:
Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
Overall Number of Participants Analyzed 16 74
Measure Type: Number
Unit of Measure: number of adverse events
298 302
Time Frame Up to 266 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With Previously Untreated CLL Patients With iNHL
Hide Arm/Group Description Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes. Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
All-Cause Mortality
Patients With Previously Untreated CLL Patients With iNHL
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patients With Previously Untreated CLL Patients With iNHL
Affected / at Risk (%) Affected / at Risk (%)
Total   6/16 (37.50%)   27/74 (36.49%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  1/16 (6.25%)  4/74 (5.41%) 
Cardiac disorders     
Atrial fibrillation * 1  1/16 (6.25%)  0/74 (0.00%) 
Cardiac arrest * 1  0/16 (0.00%)  1/74 (1.35%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/16 (0.00%)  2/74 (2.70%) 
Diarrhoea * 1  0/16 (0.00%)  1/74 (1.35%) 
Nausea * 1  0/16 (0.00%)  2/74 (2.70%) 
Stomatitis * 1  0/16 (0.00%)  1/74 (1.35%) 
Vomiting * 1  0/16 (0.00%)  2/74 (2.70%) 
General disorders     
Asthenia * 1  0/16 (0.00%)  1/74 (1.35%) 
Chills * 1  0/16 (0.00%)  1/74 (1.35%) 
Multi-organ failure * 1  0/16 (0.00%)  1/74 (1.35%) 
Pyrexia * 1  3/16 (18.75%)  6/74 (8.11%) 
Systemic inflammatory response syndrome * 1  1/16 (6.25%)  0/74 (0.00%) 
Immune system disorders     
Hypersensitivity * 1  0/16 (0.00%)  1/74 (1.35%) 
Infections and infestations     
Bronchopneumonia * 1  1/16 (6.25%)  0/74 (0.00%) 
Herpes zoster * 1  0/16 (0.00%)  1/74 (1.35%) 
Neutropenic sepsis * 1  1/16 (6.25%)  0/74 (0.00%) 
Nocardiosis * 1  0/16 (0.00%)  1/74 (1.35%) 
Pneumocystis jiroveci pneumonia * 1  0/16 (0.00%)  2/74 (2.70%) 
Pneumonia * 1  0/16 (0.00%)  3/74 (4.05%) 
Toxic shock syndrome * 1  0/16 (0.00%)  1/74 (1.35%) 
Urosepsis * 1  0/16 (0.00%)  1/74 (1.35%) 
Injury, poisoning and procedural complications     
Infusion related reaction * 1  0/16 (0.00%)  1/74 (1.35%) 
Transfusion reaction * 1  0/16 (0.00%)  1/74 (1.35%) 
Metabolism and nutrition disorders     
Hypokalaemia * 1  0/16 (0.00%)  1/74 (1.35%) 
Tumour lysis syndrome * 1  2/16 (12.50%)  0/74 (0.00%) 
Nervous system disorders     
Cerebral haemorrhage * 1  0/16 (0.00%)  1/74 (1.35%) 
Cerebrovascular accident * 1  1/16 (6.25%)  0/74 (0.00%) 
Peripheral motor neuropathy * 1  0/16 (0.00%)  1/74 (1.35%) 
Syncope * 1  0/16 (0.00%)  2/74 (2.70%) 
Renal and urinary disorders     
Renal failure acute * 1  1/16 (6.25%)  2/74 (2.70%) 
Ureteric obstruction * 1  0/16 (0.00%)  1/74 (1.35%) 
Urinary retention * 1  0/16 (0.00%)  1/74 (1.35%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease * 1  0/16 (0.00%)  1/74 (1.35%) 
Productive cough * 1  1/16 (6.25%)  0/74 (0.00%) 
Pulmonary embolism * 1  0/16 (0.00%)  1/74 (1.35%) 
Respiratory failure * 1  0/16 (0.00%)  1/74 (1.35%) 
Vascular disorders     
Hypotension * 1  1/16 (6.25%)  1/74 (1.35%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients With Previously Untreated CLL Patients With iNHL
Affected / at Risk (%) Affected / at Risk (%)
Total   16/16 (100.00%)   72/74 (97.30%) 
Blood and lymphatic system disorders     
Anaemia * 1  4/16 (25.00%)  17/74 (22.97%) 
Febrile neutropenia * 1  1/16 (6.25%)  2/74 (2.70%) 
Haemolysis * 1  1/16 (6.25%)  0/74 (0.00%) 
Leukocytosis * 1  1/16 (6.25%)  0/74 (0.00%) 
Lymphadenopathy * 1  1/16 (6.25%)  3/74 (4.05%) 
Neutropenia * 1  5/16 (31.25%)  24/74 (32.43%) 
Thrombocytopenia * 1  5/16 (31.25%)  14/74 (18.92%) 
Cardiac disorders     
Cardiac failure congestive * 1  1/16 (6.25%)  0/74 (0.00%) 
Sinus tachycardia * 1  1/16 (6.25%)  2/74 (2.70%) 
Tachycardia * 1  1/16 (6.25%)  2/74 (2.70%) 
Ear and labyrinth disorders     
Vertigo * 1  1/16 (6.25%)  2/74 (2.70%) 
Gastrointestinal disorders     
Abdominal distension * 1  1/16 (6.25%)  2/74 (2.70%) 
Abdominal pain * 1  2/16 (12.50%)  2/74 (2.70%) 
Abdominal pain upper * 1  1/16 (6.25%)  3/74 (4.05%) 
Anal pruritus * 1  1/16 (6.25%)  0/74 (0.00%) 
Constipation * 1  5/16 (31.25%)  23/74 (31.08%) 
Diarrhoea * 1  9/16 (56.25%)  21/74 (28.38%) 
Dry mouth * 1  2/16 (12.50%)  10/74 (13.51%) 
Dyspepsia * 1  1/16 (6.25%)  15/74 (20.27%) 
Dysphagia * 1  1/16 (6.25%)  1/74 (1.35%) 
Flatulence * 1  1/16 (6.25%)  1/74 (1.35%) 
Gastrooesophageal reflux disease * 1  1/16 (6.25%)  2/74 (2.70%) 
Haemorrhoids * 1  0/16 (0.00%)  4/74 (5.41%) 
Mouth ulceration * 1  1/16 (6.25%)  2/74 (2.70%) 
Nausea * 1  12/16 (75.00%)  50/74 (67.57%) 
Reflux gastritis * 1  1/16 (6.25%)  1/74 (1.35%) 
Stomatitis * 1  1/16 (6.25%)  7/74 (9.46%) 
Vomiting * 1  9/16 (56.25%)  26/74 (35.14%) 
General disorders     
Asthenia * 1  2/16 (12.50%)  5/74 (6.76%) 
Chest pain * 1  2/16 (12.50%)  4/74 (5.41%) 
Chills * 1  3/16 (18.75%)  11/74 (14.86%) 
Fatigue * 1  8/16 (50.00%)  43/74 (58.11%) 
Infusion related reaction * 1  1/16 (6.25%)  3/74 (4.05%) 
Injection site phlebitis * 1  1/16 (6.25%)  0/74 (0.00%) 
Malaise * 1  2/16 (12.50%)  2/74 (2.70%) 
Mucosal inflammation * 1  0/16 (0.00%)  4/74 (5.41%) 
Oedema peripheral * 1  2/16 (12.50%)  12/74 (16.22%) 
Pain * 1  1/16 (6.25%)  2/74 (2.70%) 
Pyrexia * 1  4/16 (25.00%)  21/74 (28.38%) 
Infections and infestations     
Cystitis * 1  1/16 (6.25%)  0/74 (0.00%) 
Eye infection * 1  1/16 (6.25%)  0/74 (0.00%) 
Herpes virus infection * 1  1/16 (6.25%)  1/74 (1.35%) 
Herpes zoster * 1  0/16 (0.00%)  6/74 (8.11%) 
Nasopharyngitis * 1  2/16 (12.50%)  1/74 (1.35%) 
Rhinitis * 1  1/16 (6.25%)  0/74 (0.00%) 
Rhinovirus infection * 1  1/16 (6.25%)  0/74 (0.00%) 
Sepsis * 1  1/16 (6.25%)  0/74 (0.00%) 
Skin infection * 1  1/16 (6.25%)  1/74 (1.35%) 
Upper respiratory tract infection * 1  0/16 (0.00%)  5/74 (6.76%) 
Urinary tract infection * 1  1/16 (6.25%)  2/74 (2.70%) 
Injury, poisoning and procedural complications     
Contusion * 1  1/16 (6.25%)  2/74 (2.70%) 
Excoriation * 1  1/16 (6.25%)  0/74 (0.00%) 
Investigations     
Blood alkaline phosphatase increased * 1  1/16 (6.25%)  1/74 (1.35%) 
Blood bilirubin increased * 1  1/16 (6.25%)  2/74 (2.70%) 
Blood creatinine increased * 1  2/16 (12.50%)  0/74 (0.00%) 
Blood lactate dehydrogenase increased * 1  2/16 (12.50%)  1/74 (1.35%) 
Blood magnesium decreased * 1  1/16 (6.25%)  0/74 (0.00%) 
Blood urea increased * 1  1/16 (6.25%)  1/74 (1.35%) 
Gamma-glutamyltransferase increased * 1  2/16 (12.50%)  1/74 (1.35%) 
Haemoglobin decreased * 1  0/16 (0.00%)  6/74 (8.11%) 
Haptoglobin decreased * 1  1/16 (6.25%)  0/74 (0.00%) 
Lymphocyte count decreased * 1  2/16 (12.50%)  1/74 (1.35%) 
Neutrophil count decreased * 1  4/16 (25.00%)  7/74 (9.46%) 
Platelet count decreased * 1  2/16 (12.50%)  11/74 (14.86%) 
Weight decreased * 1  2/16 (12.50%)  9/74 (12.16%) 
White blood cell count decreased * 1  2/16 (12.50%)  6/74 (8.11%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  4/16 (25.00%)  20/74 (27.03%) 
Hypercalcaemia * 1  1/16 (6.25%)  3/74 (4.05%) 
Hyperchloraemia * 1  3/16 (18.75%)  0/74 (0.00%) 
Hyperglycaemia * 1  3/16 (18.75%)  1/74 (1.35%) 
Hyperkalaemia * 1  2/16 (12.50%)  1/74 (1.35%) 
Hyperuricaemia * 1  1/16 (6.25%)  1/74 (1.35%) 
Hypokalaemia * 1  2/16 (12.50%)  6/74 (8.11%) 
Hypomagnesaemia * 1  3/16 (18.75%)  5/74 (6.76%) 
Hyponatraemia * 1  1/16 (6.25%)  0/74 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/16 (6.25%)  7/74 (9.46%) 
Back pain * 1  2/16 (12.50%)  7/74 (9.46%) 
Flank pain * 1  1/16 (6.25%)  0/74 (0.00%) 
Joint swelling * 1  1/16 (6.25%)  2/74 (2.70%) 
Muscle atrophy * 1  1/16 (6.25%)  0/74 (0.00%) 
Muscle spasms * 1  1/16 (6.25%)  4/74 (5.41%) 
Musculoskeletal pain * 1  2/16 (12.50%)  1/74 (1.35%) 
Myalgia * 1  2/16 (12.50%)  6/74 (8.11%) 
Neck pain * 1  1/16 (6.25%)  2/74 (2.70%) 
Pain in extremity * 1  0/16 (0.00%)  4/74 (5.41%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Meningioma * 1  1/16 (6.25%)  0/74 (0.00%) 
Nervous system disorders     
Ageusia * 1  1/16 (6.25%)  0/74 (0.00%) 
Amnesia * 1  1/16 (6.25%)  2/74 (2.70%) 
Disturbance in attention * 1  1/16 (6.25%)  3/74 (4.05%) 
Dizziness * 1  2/16 (12.50%)  13/74 (17.57%) 
Dysgeusia * 1  0/16 (0.00%)  17/74 (22.97%) 
Headache * 1  5/16 (31.25%)  17/74 (22.97%) 
Psychiatric disorders     
Anxiety * 1  2/16 (12.50%)  4/74 (5.41%) 
Insomnia * 1  0/16 (0.00%)  6/74 (8.11%) 
Renal and urinary disorders     
Dysuria * 1  1/16 (6.25%)  1/74 (1.35%) 
Micturition urgency * 1  1/16 (6.25%)  1/74 (1.35%) 
Pollakiuria * 1  0/16 (0.00%)  5/74 (6.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  3/16 (18.75%)  13/74 (17.57%) 
Dyspnoea * 1  3/16 (18.75%)  9/74 (12.16%) 
Epistaxis * 1  1/16 (6.25%)  0/74 (0.00%) 
Haemoptysis * 1  1/16 (6.25%)  0/74 (0.00%) 
Hypoxia * 1  1/16 (6.25%)  1/74 (1.35%) 
Nasal congestion * 1  0/16 (0.00%)  4/74 (5.41%) 
Oropharyngeal pain * 1  2/16 (12.50%)  8/74 (10.81%) 
Pleural effusion * 1  1/16 (6.25%)  1/74 (1.35%) 
Skin and subcutaneous tissue disorders     
Dermatitis exfoliative * 1  1/16 (6.25%)  0/74 (0.00%) 
Dry skin * 1  1/16 (6.25%)  2/74 (2.70%) 
Erythema * 1  1/16 (6.25%)  5/74 (6.76%) 
Hyperhidrosis * 1  1/16 (6.25%)  1/74 (1.35%) 
Night sweats * 1  0/16 (0.00%)  4/74 (5.41%) 
Pruritus * 1  1/16 (6.25%)  7/74 (9.46%) 
Rash * 1  2/16 (12.50%)  8/74 (10.81%) 
Rash generalised * 1  1/16 (6.25%)  0/74 (0.00%) 
Rash maculo-papular * 1  2/16 (12.50%)  1/74 (1.35%) 
Rash papular * 1  2/16 (12.50%)  0/74 (0.00%) 
Vascular disorders     
Hot flush * 1  1/16 (6.25%)  1/74 (1.35%) 
Hypertension * 1  1/16 (6.25%)  1/74 (1.35%) 
Hypotension * 1  1/16 (6.25%)  4/74 (5.41%) 
Phlebitis * 1  0/16 (0.00%)  5/74 (6.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13
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 results of this study will be published. Authors of the primary publication based on this study must fulfil the criteria defined by the International Committee of Medical Journal Editors (ICMJE). The primary publication must be published before any secondary publications are submitted for publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lundbeck Canada Inc.
Organization: Lundbeck Canada Inc.
Phone: +45 36301311
EMail: LundbeckClinicalTrials@lundbeck.com
Layout table for additonal information
Responsible Party: Lundbeck Canada Inc.
ClinicalTrials.gov Identifier: NCT01500083     History of Changes
Other Study ID Numbers: 14293A
First Submitted: December 16, 2011
First Posted: December 26, 2011
Results First Submitted: October 10, 2014
Results First Posted: October 16, 2014
Last Update Posted: August 14, 2017