Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000445077
Ethics application status
Approved
Date submitted
25/05/2010
Date registered
1/06/2010
Date last updated
13/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL).
Scientific title
An open-label, randomized, parallel-group study to compare the complete response (CR) rate of Bendamustine and Rituximab (BR) with that of standard treatment regimens of either Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the first-line treatment of patients with advanced indolent non-Hodgkin's lymphoma or mantle cell lymphoma.
Secondary ID [1] 251860 0
ClinicalTrials.gov Identifier NCT00877006
Universal Trial Number (UTN)
Trial acronym
BRIGHT Study

Bendamustine Rituximab InvestiGational non-Hodgkin's Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma 257460 0
Condition category
Condition code
Cancer 257607 257607 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 257608 257608 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name of intervention being studied:
Bendamustine Hydrochloride (administered in combination with Rituximab)

Patients will be randomly assigned to either investigational treatment (BR) or standard treatment (R-CVP or R-CHOP). Six cycles of treatment are planned, with a maximum of eight treatment cycles permitted as the discretion of the investigator and after discussion with the sponsor or sponsor's designee.

If randomised to the investigational treatment arm, patients will receive Bendamustine Hydrochloride at 90mg per metre squared (body surface area) intravenously on days 1 and 2 of each 28-day cycle. Additionally, patients will receive Rituximab at 375mg per metre squared intravenously on day 1 of every cycle of treatment.

The Bendamustine and Rituximab are infused separately:
* Bendamustine: approximately 30 minute infusion
* Rituximab: Infusion duration will vary depending on the size (height and weight) of the patient:
- Cycle 1 - approximately 3-5 hours
- Cycle 2 onwards - approximately 2-4 hours (if Cycle 1 was well tolerated)
Intervention code [1] 256551 0
Treatment: Drugs
Comparator / control treatment
If randomised to the standard treatment arm, patients will receive either R-CVP or R-CHOP. Each investigator must select the standard treatment clinically appropriate for the patient.

R-CVP
Patients treated with R-CVP will be administered Rituximab at 375mg per metre squared intravenously, Cyclophosphamide at 750 or 1000mg per metre squared intravenously, and Vincristine at 1.4mg per metre squared (2mg maximum) intravenously on day 1 of each 21-day cycle, and Prednisone at 100mg/day orally on days 1 through 5.

R-CHOP
Patients treated with R-CHOP will be administered Rituximab at 375mg per metre squared intravenously, Cyclophosphamide at 750mg per metre squared intravenously, Doxorubicin at 50mg per metre squared intravenously, and Vincristine at 1.4mg per metre squared (2mg maximum) intravenously on day 1 of each 21-day cycle, and Prednisone at 100mg/day orally on days 1 through 5.

In both R-CVP and R-CHOP, all intravenous drugs are infused separately. For all drugs, infusion duration will vary depending on the size (height and weight) of the patient:
* Rituximab: approximately 1-4 hours
* Cyclophosphamide: approximately 10-60 minutes
* Doxorubicin: approximately 10-30 minutes
* Vincristine: approximately 5-30 minutes
Control group
Active

Outcomes
Primary outcome [1] 258520 0
To compare the complete response (CR) rate of BR with that of the standard treatment regimens of either R-CVP or R-CHOP

This outcome is assessed using the following tools/tests:
* Computed Tomography (CT) scan and/or Positron Emission Tomography (PET) scan
* Bone marrow biopsy and aspirate (in some cases)
* Blood test
* Assessment of wellness and physical examination
Timepoint [1] 258520 0
At the end of Cycle 3 of treatment
At the end of Cycle 6 of treatment
At the end of Cycle 8 of treatment (if applicable)
Secondary outcome [1] 264334 0
To compare the following between the investigational treatment group (BR) and the standard treatment group (R-CVP or R-CHOP):

Overall Response Rate

This outcome is assessed using the following tools/tests:
* CT scan and/or PET scan
* Bone marrow biopsy and aspirate (in some cases)
* Blood test
* Assessment of wellness and physical examination
Timepoint [1] 264334 0
At the end of Cycle 3 of treatment
At the end of Cycle 6 of treatment
At the end of Cycle 8 of treatment (if applicable)
Secondary outcome [2] 264335 0
To compare the following between the investigational treatment group (BR) and the standard treatment group (R-CVP or R-CHOP):

Progression-Free Survival

The following tools/tests may be used to assess this outcome:
* Assessment of wellness and physical examination
* Telephone follow-up calls
* Blood test
* CT scan and/or PET scan
* Bone marrow biopsy and aspirate
Timepoint [2] 264335 0
Throughout treatment and follow-up period (which lasts for at least five years post treatment completion).

This outcome is assessed at the end of Cycle 3, Cycle 6 and Cycle 8 (if applicable), and on at least an annual basis during follow-up.
Secondary outcome [3] 264336 0
To compare the following between the investigational treatment group (BR) and the standard treatment group (R-CVP or R-CHOP):

Event-Free Survival

The following tools/tests may be used to assess this outcome:
* Assessment of wellness and physical examination
* Telephone follow-up calls
* Blood test
* CT scan and/or PET scan
* Bone marrow biopsy and aspirate
Timepoint [3] 264336 0
Throughout treatment and follow-up period (which lasts for at least five years post treatment completion).

This outcome is assessed at the end of Cycle 3, Cycle 6 and Cycle 8 (if applicable), and on at least an annual basis during follow-up.
Secondary outcome [4] 264337 0
To compare the following between the investigational treatment group (BR) and the standard treatment group (R-CVP or R-CHOP):

Median Durations of Response

The following tools/tests may be used to assess this outcome:
* Assessment of wellness and physical examination
* Telephone follow-up calls
* Blood test
* CT scan and/or PET scan
* Bone marrow biopsy and aspirate
Timepoint [4] 264337 0
Monitored yearly during a minimum 5-year follow-up period, once treatment is completed
Secondary outcome [5] 264338 0
To compare the following between the investigational treatment group (BR) and the standard treatment group (R-CVP or R-CHOP):

Overall Survival

The following tools/tests may be used to assess this outcome:
* Assessment of wellness and physical examination
* Telephone follow-up calls
Timepoint [5] 264338 0
Monitored yearly during a minimum 5-year follow-up period, once treatment is completed
Secondary outcome [6] 264339 0
To compare the following between the investigational treatment group (BR) and the standard treatment group (R-CVP or R-CHOP):

Quality of Life

This outcome is assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30).
Timepoint [6] 264339 0
At the end of Cycle 1 of treatment
At the end of Cycle 3 of treatment
At the end of Cycle 6 of treatment
At the end of Cycle 8 of treatment (if applicable)
Secondary outcome [7] 264340 0
To compare the following between the investigational treatment group (BR) and the standard treatment group (R-CVP or R-CHOP):

Safety and Tolerability

The following tools/tests may be used to assess this outcome:
* Assessment of wellness and physical examination
* Discussion with doctor regarding any side effects
* Telephone follow-up calls
* Blood tests
Timepoint [7] 264340 0
Throughout treatment period and until 30 days after the last dose of study drug

This outcome is assessed at the start of each treatment cycle as well as at the end of Cycle 3, Cycle 6 and Cycle 8 (if applicable). Assessment may also take place between these visits either when the patient undertakes their weekly blood test or else over the telephone.

Eligibility
Key inclusion criteria
(a) Histopathologic confirmation of 1 of the following CD20+ B-cell non-Hodgkin’s lymphomas (World Health Organization [WHO]/Revised European American Classification of Lymphoid Neoplasms [REAL] classifications described below). Tissue diagnostic
procedures must be performed within 6 months of study entry and with biopsy material available for review:
* follicular lymphoma (grade 1 or 2)
* immunoplasmacytoma/immunocytoma (Waldenstrom’s macroglobulinemia)
* splenic marginal zone B-cell lymphoma
* extra-nodal marginal zone lymphoma of mucosa associated lymphoid tumor (MALT) type
* nodal marginal zone B-cell lymphoma
* mantle cell lymphoma

(b) The patient meets 1 of the following need-for–treatment criteria with the exception of mantle cell lymphoma, for which treatment is always indicated:
* presence of at least 1 of the following B-symptoms:
** fever (>38 degrees C) of unclear etiology
** night sweats
** weight loss of greater than 10% within the prior 6 months
* large tumor mass (bulky disease) characterized by lymphomas with a diameter of more than 3 cm in 3 or more regions or by a lymphoma with a diameter of more than 7 cm in 1 region
* presence of lymphoma-related complications, including narrowing of ureters or bile ducts, tumor-related compression of a vital organ, lymphoma induced pain, cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, or ascites
* hyperviscosity syndrome due to monoclonal gammopathy

(c) The patient has CD20 positive B cells in the lymph node biopsy or other lymphoma pathology specimen.

(e) The patient was not previously treated. Patients on “watch and wait” may enter the study if a recent biopsy (obtained within the last 6 months) is obtainable.

(f) The patient has adequate hematologic function (unless abnormalities are related to lymphoma infiltration of the bone marrow or hypersplenism due to lymphoma) within 30 days prior to start of study drug as evidenced by the following:
* hemoglobin of 10.0 g/dl or greater
* absolute neutrophil count (ANC) of 1.5 x 109/L or greater
* platelet count of 100 x109/L or greater

(g) The patient has bidimensionally measurable disease with at least 1 lesion measuring 2.0 cm or more in a single dimension, and the field was not previously radiated.

(h) The patient is able to provide written informed consent.

(i) The patient is 18 years of age or older at the time of informed consent.

(j) The patient has an Eastern Cooperative Oncology Group (ECOG) performance status 2 or less.

(k) The patient has an estimated life expectancy of at least 6 months.

(l) The patient has serum creatinine of 2.0 mg/dL or less, or Creatinine Clearance of 50 mL/min or more based on the Cockcroft-Gault method or from a 24-hour urine collection.

(m) The patient has adequate hepatic organ function (less than or equal to 2.5 times the upper limit of normal for alanine aminotransferase [ALT], asparate aminotransferase [AST], and alkaline phosphatase and total bilirubin within normal limits).

(n) The patient has left ventricular ejection fraction (LVEF) 50% or greater by Multiple Uptake Gated Aquisition (MUGA) scan or Echocardiogram (ECHO) within 30 days prior to start of study drug treatment for any patient who will be treated with R-CHOP.

(o) Women of childbearing potential (not surgically sterile or at least 12 months naturally postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include abstinence, barrier method with spermicide (excluding cervical cap and sponge), intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.

(p) Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of treatment and for 30 days after the end of treatment.

(Please note: Inclusion Criteria D was removed from the most recent version of the study protocol)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) The patient has chronic lymphocytic leukemia, small lymphocytic lymphoma, or grade 3 follicular lymphoma.

(b) The patient has transformed disease. Specifically, bone marrow blasts are permitted, however, transformed disease indicating leukemic involvement is not permitted.

(c) The patient has the presence or history of central nervous system (CNS) involvement or leptomeningeal lymphoma.

(d) The patient had prior treatment for NHL except for a single course of locally delimited radiation therapy (radiation field not exceeding 2 adjacent lymph node regions).

(e) The patient has had an active malignancy, other than NHL, within the past 3 years except for localized prostate cancer treated with hormone therapy, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer that has been definitively treated.

(f) The patient has New York Heart Association (NYHA) Class III or IV heart failure, arrhythmias or unstable angina, electrocardiographic evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months. (Prior to study entry, Electrocardiogram (ECG) abnormalities at screening must be documented by the investigator as not medically relevant).

(g) The patient has a known human immunodeficiency virus (HIV) infection.

(h) The patient has active hepatitis B or hepatitis C infection. Hepatitis B surface antigen must be tested, otherwise the determination of active hepatitis B or C is left
to the investigator.

(i) The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)

(j) The patient has received corticosteroids for treatment of lymphoma within 28 days of study entry. Chronically administered low-dose corticosteroids (eg, prednisone
=20 mg/day) for indications other than lymphoma or lymphoma-related complications are permitted.

(k) The patient has any serious uncontrolled, medical or psychological disorder that would impair the ability of the patient to receive protocol therapy.

(l) The patient has any condition which places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data.

(m) The patient has received other investigational agent within 28 days of study entry.

(n) The patient has known hypersensitivity to bendamustine, mannitol, or other study-related drugs.

(o) The patient has Ann Arbor stage I disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Screening will occur within 30 days prior to start of treatment with study drug, after the patient has provided informed consent. During screening, the investigator will determine the most appropriate standard treatment regimen (R-CVP or R-CHOP) for the patient. After screening, the Eligibility Verification Fax should be completed and faxed to the study monitor for medical monitor review and assessment of eligibility.

Eligible patients will be randomly assigned to either the investigational treatment group (BR) or the standard treatment group (R-CVP or R-CHOP) in a 1:1 ratio.

If the investigator has preselected R-CVP as the standard treatment, the patient will be randomly assigned to either BR or R-CVP.

If the investigator has preselected R-CHOP as the standard treatment, the patient will be randomly assigned to either BR or R-CHOP.

The randomisation code will be generated by the Cephalon Development Manufacturing Group following specifications from the Biometrics Department. A statistician not assigned to the study will be responsible for review of the randomisation code, and the final randomisation code will be maintained by the Development Manufacturing Group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An Interative Voice Response System (IVRS) will be used for screening and for randomisation.

Randomisation will be performed centrally, stratified by lymphoma type (indolent NHL or MCL) and by the investigator selection of standard treatment regimen during screening. The patient will be randomly assigned to either the investigational treatment group or standard treatment group in a 1:1 ratio.

There will be no blinding in this study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
436
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,ACT,QLD,SA,WA,TAS
Recruitment postcode(s) [1] 2922 0
2010 (St Vincent's Hospital - Sydney)
Recruitment postcode(s) [2] 2916 0
2139 (Concord Repatriation General Hospital)
Recruitment postcode(s) [3] 2914 0
2145 (Westmead Hospital)
Recruitment postcode(s) [4] 2913 0
2605 (Canberra Hospital)
Recruitment postcode(s) [5] 2918 0
3004 (The Alfred Hospital)
Recruitment postcode(s) [6] 2929 0
3050 (Royal Melbourne Hospital)
Recruitment postcode(s) [7] 2921 0
3065 (St Vincent's Hospital - Melbourne)
Recruitment postcode(s) [8] 2919 0
3144 (Cabrini Hospital)
Recruitment postcode(s) [9] 2928 0
3220 (Geelong Hospital)
Recruitment postcode(s) [10] 2925 0
3690 (Border Medical Oncology)
Recruitment postcode(s) [11] 2912 0
4101 (Mater Adult Hospital)
Recruitment postcode(s) [12] 2920 0
4102 (Princess Alexandra Hospital)
Recruitment postcode(s) [13] 2927 0
4814 (Townsville Hospital)
Recruitment postcode(s) [14] 2917 0
5000 (Royal Adelaide Hospital)
Recruitment postcode(s) [15] 2924 0
5011 (The Queen Elizabeth Hospital)
Recruitment postcode(s) [16] 2923 0
5037 (Ashford Cancer Centre)
Recruitment postcode(s) [17] 2926 0
6000 (Royal Perth Hospital)
Recruitment postcode(s) [18] 2915 0
7000 (Royal Hobart Hospital)
Recruitment outside Australia
Country [1] 2657 0
United States of America
State/province [1] 2657 0
Country [2] 2658 0
Canada
State/province [2] 2658 0
Country [3] 2659 0
Brazil
State/province [3] 2659 0
Country [4] 2660 0
Argentina
State/province [4] 2660 0
Country [5] 2661 0
New Zealand
State/province [5] 2661 0
Christchurch - Christchurch Hospital
Country [6] 2662 0
New Zealand
State/province [6] 2662 0
Wellington - Wellington Hospital
Country [7] 2663 0
New Zealand
State/province [7] 2663 0
Palmerston North - Palmerston North Hospital
Country [8] 2664 0
New Zealand
State/province [8] 2664 0
Auckland - Auckland City Hospital
Country [9] 2665 0
New Zealand
State/province [9] 2665 0
Auckland - North Shore Hospital
Country [10] 2666 0
New Zealand
State/province [10] 2666 0
Auckland - Middlemore Hospital
Country [11] 2667 0
Peru
State/province [11] 2667 0
Country [12] 2668 0
Mexico
State/province [12] 2668 0

Funding & Sponsors
Funding source category [1] 257049 0
Commercial sector/Industry
Name [1] 257049 0
Cephalon Inc
Country [1] 257049 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Cephalon Inc
Address
41 Moores Road
Frazer, Pennsylvania, 19355
USA
Country
United States of America
Secondary sponsor category [1] 256307 0
Commercial sector/Industry
Name [1] 256307 0
PPD
Address [1] 256307 0
PPD Australia Pty Ltd
Level 9, 5 Queens Road Melbourne VIC 3004, Australia
Country [1] 256307 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259061 0
Mater Health Services Human Research Ethics Committee (HREC)
Ethics committee address [1] 259061 0
Raymond Terrace
South Brisbane, QLD, 4101
Ethics committee country [1] 259061 0
Australia
Date submitted for ethics approval [1] 259061 0
Approval date [1] 259061 0
10/07/2009
Ethics approval number [1] 259061 0
1344A
Ethics committee name [2] 259062 0
ACT Health HREC
Ethics committee address [2] 259062 0
Canberra Hospital
Level 6, Building 10
The ACT Health Research Office
Woden, ACT, 2605
Ethics committee country [2] 259062 0
Australia
Date submitted for ethics approval [2] 259062 0
Approval date [2] 259062 0
11/08/2009
Ethics approval number [2] 259062 0
3/09/0332
Ethics committee name [3] 259063 0
Sydney South West Area Health Service HREC
Ethics committee address [3] 259063 0
Concord Repatriation General Hospital
Hospital Road
Concord, NSW, 2139
Ethics committee country [3] 259063 0
Australia
Date submitted for ethics approval [3] 259063 0
Approval date [3] 259063 0
09/06/2009
Ethics approval number [3] 259063 0
CH62/6/2009-034
Ethics committee name [4] 259064 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [4] 259064 0
University of Tasmania
Office of Research Services
Private Bag 1
Hobart, TAS, 7001
Ethics committee country [4] 259064 0
Australia
Date submitted for ethics approval [4] 259064 0
Approval date [4] 259064 0
23/03/2009
Ethics approval number [4] 259064 0
H00010452
Ethics committee name [5] 259065 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [5] 259065 0
Royal Adelaide Hospital
Level 3, Hanson Institute
North Terrace
Adelaide, SA, 5000
Ethics committee country [5] 259065 0
Australia
Date submitted for ethics approval [5] 259065 0
Approval date [5] 259065 0
26/05/2009
Ethics approval number [5] 259065 0
090427
Ethics committee name [6] 259066 0
The Alfred Research & Ethics Unit
Ethics committee address [6] 259066 0
The Alfred Hospital
55 Commercial Road
Melbourne, VIC, 3004
Ethics committee country [6] 259066 0
Australia
Date submitted for ethics approval [6] 259066 0
Approval date [6] 259066 0
15/07/2009
Ethics approval number [6] 259066 0
1/09/0117
Ethics committee name [7] 259067 0
Cabrini Human Research Ethics Committee
Ethics committee address [7] 259067 0
Cabrini Hospital
183 Wattletree Road
Malvern, VIC, 3144
Ethics committee country [7] 259067 0
Australia
Date submitted for ethics approval [7] 259067 0
Approval date [7] 259067 0
08/07/2009
Ethics approval number [7] 259067 0
11-02-03-09
Ethics committee name [8] 259068 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [8] 259068 0
Princess Alexandra Hospital
Level 2, Building 35
Ipswich Road
Woolloongabba, QLD, 4102
Ethics committee country [8] 259068 0
Australia
Date submitted for ethics approval [8] 259068 0
Approval date [8] 259068 0
17/08/2009
Ethics approval number [8] 259068 0
2009/046
Ethics committee name [9] 259069 0
St Vincent's Hospital (Melbourne) HREC-D
Ethics committee address [9] 259069 0
St Vincent's Hospital
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy, VIC, 3065
Ethics committee country [9] 259069 0
Australia
Date submitted for ethics approval [9] 259069 0
Approval date [9] 259069 0
25/02/2010
Ethics approval number [9] 259069 0
1/09/0121
Ethics committee name [10] 259070 0
Bellberry Human Research Ethics Committee
Ethics committee address [10] 259070 0
229 Greenhill Road
Dulwich, SA, 5065
Ethics committee country [10] 259070 0
Australia
Date submitted for ethics approval [10] 259070 0
Approval date [10] 259070 0
26/11/2009
Ethics approval number [10] 259070 0
A178/09
Ethics committee name [11] 259071 0
Central Northern Adelaide Health Service Ethics of Human Research Committee
Ethics committee address [11] 259071 0
28 Woodville Road
Woodville South, SA, 5011
Ethics committee country [11] 259071 0
Australia
Date submitted for ethics approval [11] 259071 0
Approval date [11] 259071 0
12/11/2009
Ethics approval number [11] 259071 0
2009155
Ethics committee name [12] 259072 0
Joint Hospitals Ethics Committee
Ethics committee address [12] 259072 0
Wodonga Regional Health Service
Vermont Street
Wodonga, VIC, 3690
Ethics committee country [12] 259072 0
Australia
Date submitted for ethics approval [12] 259072 0
Approval date [12] 259072 0
07/12/2009
Ethics approval number [12] 259072 0
9/09/0331
Ethics committee name [13] 259073 0
Royal Perth Hospital Ethics Committee
Ethics committee address [13] 259073 0
Royal Perth Hospital
Level 5, Colonial House
Wellington Street
Perth, WA, 6000
Ethics committee country [13] 259073 0
Australia
Date submitted for ethics approval [13] 259073 0
Approval date [13] 259073 0
10/02/2010
Ethics approval number [13] 259073 0
2009/119
Ethics committee name [14] 259074 0
Barwon Health Human Research Ethics Committee
Ethics committee address [14] 259074 0
Geelong Hospital
PO Box 281
Ryrie Street
Geelong, VIC, 3220
Ethics committee country [14] 259074 0
Australia
Date submitted for ethics approval [14] 259074 0
Approval date [14] 259074 0
03/02/2010
Ethics approval number [14] 259074 0
1/09/0126
Ethics committee name [15] 259075 0
The Townsville Health Service District Human Research Ethics Committee
Ethics committee address [15] 259075 0
PO Box 670
Townsville, QLD, 4810
Ethics committee country [15] 259075 0
Australia
Date submitted for ethics approval [15] 259075 0
Approval date [15] 259075 0
18/12/2009
Ethics approval number [15] 259075 0
HREC/09/QTHS/106
Ethics committee name [16] 259076 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [16] 259076 0
Royal Melbourne Hospital
Main Block, Level 6 East
Grattan Street
Parkville, VIC, 3050
Ethics committee country [16] 259076 0
Australia
Date submitted for ethics approval [16] 259076 0
Approval date [16] 259076 0
18/03/2010
Ethics approval number [16] 259076 0
2010.032

Summary
Brief summary
This study looks at the effectiveness and safety of the chemotherapy drug Bendamustine in treating advanced slow-growing non-Hodgkin's lymphoma or mantle cell lymphoma.

Who is it for?
You may be able to join this study if you have advanced indolent non-Hodgkin's lymphoma or mantle cell lymphoma.

Trial details
Participants will be randomly divided into two groups. One group will receive a combination of the drugs Bendamustine and Rituximab (BR). The other will receive standard treatment with either Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP).

The study aims to compare the efficacy and safety of the combination of Bendamustine and Rituximab (BR) to the current standard treatments.
Trial website
http://www.treandaclinicalresearch.com/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31219 0
Address 31219 0
Country 31219 0
Phone 31219 0
Fax 31219 0
Email 31219 0
Contact person for public queries
Name 14466 0
Rochelle Mann
Address 14466 0
PPD Australia Pty Ltd
Level 9
5 Queens Road
Melbourne, VIC, 3004
Country 14466 0
Australia
Phone 14466 0
+61 3 9804 5211
Fax 14466 0
Email 14466 0
rochelle.mann@ppdi.com
Contact person for scientific queries
Name 5394 0
Rochelle Mann
Address 5394 0
PPD Australia Pty Ltd
Level 9
5 Queens Road
Melbourne, VIC, 3004
Country 5394 0
Australia
Phone 5394 0
+61 3 9804 5211
Fax 5394 0
Email 5394 0
rochelle.mann@ppdi.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.