Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000105640
Ethics application status
Approved
Date submitted
4/08/2005
Date registered
9/08/2005
Date last updated
8/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase-II study of a modified Hyper-CVAD frontline therapy for patients with poor prognosis diffuse large B-cell and peripheral T-cell non-Hodgkins lymphoma to evaluate safety and improve remission rate.
Scientific title
A phase-II study of a modified Hyper-CVAD frontline therapy for patients with poor prognosis diffuse large B-cell and peripheral T-cell non-Hodgkins lymphoma to evaluate safety and improve remission rate.
Secondary ID [1] 105 0
Australasian Leukaemia and Lymphoma Group (ALLG): ALLG NHL11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Histologically aggressive non-Hodgkins lymphoma 187 0
B- or T-cell lineage with a poor prognosis (International Prognostic Factors Index score of 2 or greater). 188 0
Condition category
Condition code
Cancer 212 212 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A dose and time intensive chemotherapy regimen comprising alternating A and B cycles. A cycles comprise hyperfractionate cyclophosphamide, vincristine, doxorubicin and dexamethasone, and B cycles comprise high-dose methotrexate and high-dose cytosine arabinoside. A total of 6 cycles are to be delivered.
Intervention code [1] 117 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 250 0
To investigate the efficacy of the modified Hyper-CVAD regimen in the two separate groups of patients with poor prognosis (1) T-cell NHL and (2) diffuse large B-cell NHL as assessed by the CR rate achieved compared with that predicted by previously established prognostic scores. Efficacy will be assessed by complete remission rate at the completion of protocol therapy.
Timepoint [1] 250 0
At completion of protocol therapy.
Secondary outcome [1] 573 0
To document the 2-year progression-free survival of these patients.
Timepoint [1] 573 0
Secondary outcome [2] 574 0
Determine the toxicity profile of the modified regimen in this setting.
Timepoint [2] 574 0

Eligibility
Key inclusion criteria
(1)Patients with previously untreated mature (post-thymic) T-cell or NK-cell NHL and an IPI score of greater than or equal to 2 OR Patients with previously untreated diffuse large B-cell NHL (2)ECOG performance status 0 to 3 inclusive.(3)A serum creatinine of less than or equal to 0.15 mmol/L. Adequate hepatic function (bilirubin less than or equal to 2.5 x ULN), and haemopoietic indices (haemoglobin greater than or equal to 90, absolute neutrophil count greater than or equal to 1.0, platelets greater than or equal to 100), unless due to lymphomatous infiltration.(4)Seronegativity for antibodies to HIV (see 7.6)(5)Normal left ventricular ejection fraction, according to institutional criteria.(6)Written informed consent
Minimum age
15 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1)Prior diagnosis of "low-grade" NHL, although patients with discordant bone marrow histology (i.e. small cell lymphomatous infiltrate of marrow) are eligible.(2)Prior treatment for NHL.(3)Past history of serious cardiac, pulmonary, hepatic or renal disease, (4)A past history of cancer (other than non-melanoma skin cancer or carcinoma of the cervix in situ).(5)Contraindication to the use of the study drugs, including known sensitivity to E. Coli derived preparations. This includes agreement to use a medically acceptable and effective means of contraception throughout the treatment period for both male and female patients of childbearing potential.(6)Pregnant women or breast-feeding mothers. History of solid-organ transplantation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/01/2001
Actual
7/09/2001
Date of last participant enrolment
Anticipated
Actual
9/01/2008
Date of last data collection
Anticipated
Actual
7/04/2014
Sample size
Target
70
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 271 0
Commercial sector/Industry
Name [1] 271 0
Amgen Australia
Country [1] 271 0
Australia
Funding source category [2] 272 0
Commercial sector/Industry
Name [2] 272 0
Mayne Pharma
Country [2] 272 0
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
Country
Australia
Secondary sponsor category [1] 205 0
None
Name [1] 205 0
nil
Address [1] 205 0
Country [1] 205 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1103 0
Royal Adelaide
Ethics committee address [1] 1103 0
Ethics committee country [1] 1103 0
Australia
Date submitted for ethics approval [1] 1103 0
Approval date [1] 1103 0
09/10/2001
Ethics approval number [1] 1103 0
Ethics committee name [2] 1104 0
Albury Base/Murray Valley Private
Ethics committee address [2] 1104 0
Ethics committee country [2] 1104 0
Australia
Date submitted for ethics approval [2] 1104 0
Approval date [2] 1104 0
Ethics approval number [2] 1104 0
Ethics committee name [3] 1105 0
Auckland
Ethics committee address [3] 1105 0
Ethics committee country [3] 1105 0
New Zealand
Date submitted for ethics approval [3] 1105 0
Approval date [3] 1105 0
Ethics approval number [3] 1105 0
Ethics committee name [4] 1106 0
Ballarat
Ethics committee address [4] 1106 0
Ethics committee country [4] 1106 0
Australia
Date submitted for ethics approval [4] 1106 0
Approval date [4] 1106 0
Ethics approval number [4] 1106 0
Ethics committee name [5] 1107 0
Canberra
Ethics committee address [5] 1107 0
Ethics committee country [5] 1107 0
Australia
Date submitted for ethics approval [5] 1107 0
Approval date [5] 1107 0
Ethics approval number [5] 1107 0
Ethics committee name [6] 1108 0
Geelong
Ethics committee address [6] 1108 0
Ethics committee country [6] 1108 0
Australia
Date submitted for ethics approval [6] 1108 0
Approval date [6] 1108 0
Ethics approval number [6] 1108 0
Ethics committee name [7] 1109 0
Launceston
Ethics committee address [7] 1109 0
Ethics committee country [7] 1109 0
Australia
Date submitted for ethics approval [7] 1109 0
Approval date [7] 1109 0
Ethics approval number [7] 1109 0
Ethics committee name [8] 1110 0
Mater Newcastle
Ethics committee address [8] 1110 0
Ethics committee country [8] 1110 0
Australia
Date submitted for ethics approval [8] 1110 0
Approval date [8] 1110 0
Ethics approval number [8] 1110 0
Ethics committee name [9] 1111 0
Peter MacCallum
Ethics committee address [9] 1111 0
Ethics committee country [9] 1111 0
Australia
Date submitted for ethics approval [9] 1111 0
Approval date [9] 1111 0
20/07/2001
Ethics approval number [9] 1111 0
Ethics committee name [10] 1112 0
Pretoria
Ethics committee address [10] 1112 0
Ethics committee country [10] 1112 0
South Africa
Date submitted for ethics approval [10] 1112 0
Approval date [10] 1112 0
Ethics approval number [10] 1112 0
Ethics committee name [11] 1113 0
Princess Alexandra
Ethics committee address [11] 1113 0
Ethics committee country [11] 1113 0
Australia
Date submitted for ethics approval [11] 1113 0
Approval date [11] 1113 0
Ethics approval number [11] 1113 0
Ethics committee name [12] 1114 0
Queen Elizabeth
Ethics committee address [12] 1114 0
Ethics committee country [12] 1114 0
Australia
Date submitted for ethics approval [12] 1114 0
Approval date [12] 1114 0
Ethics approval number [12] 1114 0
Ethics committee name [13] 1115 0
Royal North Shore
Ethics committee address [13] 1115 0
Ethics committee country [13] 1115 0
Australia
Date submitted for ethics approval [13] 1115 0
Approval date [13] 1115 0
Ethics approval number [13] 1115 0
Ethics committee name [14] 1116 0
Royal Perth
Ethics committee address [14] 1116 0
Ethics committee country [14] 1116 0
Australia
Date submitted for ethics approval [14] 1116 0
Approval date [14] 1116 0
Ethics approval number [14] 1116 0
Ethics committee name [15] 1117 0
Royal Prince Alfred
Ethics committee address [15] 1117 0
Ethics committee country [15] 1117 0
Australia
Date submitted for ethics approval [15] 1117 0
Approval date [15] 1117 0
Ethics approval number [15] 1117 0
Ethics committee name [16] 1118 0
Toowoomba
Ethics committee address [16] 1118 0
Ethics committee country [16] 1118 0
Australia
Date submitted for ethics approval [16] 1118 0
Approval date [16] 1118 0
Ethics approval number [16] 1118 0
Ethics committee name [17] 1119 0
Townsville
Ethics committee address [17] 1119 0
Ethics committee country [17] 1119 0
Australia
Date submitted for ethics approval [17] 1119 0
Approval date [17] 1119 0
Ethics approval number [17] 1119 0
Ethics committee name [18] 1120 0
Westmead
Ethics committee address [18] 1120 0
Ethics committee country [18] 1120 0
Australia
Date submitted for ethics approval [18] 1120 0
Approval date [18] 1120 0
Ethics approval number [18] 1120 0
Ethics committee name [19] 1121 0
Wollongong
Ethics committee address [19] 1121 0
Ethics committee country [19] 1121 0
Australia
Date submitted for ethics approval [19] 1121 0
Approval date [19] 1121 0
Ethics approval number [19] 1121 0

Summary
Brief summary
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 35419 0
Address 35419 0
Country 35419 0
Phone 35419 0
Fax 35419 0
Email 35419 0
Contact person for public queries
Name 9306 0
Dr John Seymour
Address 9306 0
Peter MacCallum Cancer Centre
St. Andrews Place
East Melbourne VIC 3002
Country 9306 0
Australia
Phone 9306 0
+61 3 96561697
Fax 9306 0
+61 3 96561408
Email 9306 0
John.Seymour@petermac.org
Contact person for scientific queries
Name 234 0
Dr John Seymour
Address 234 0
Peter MacCallum Cancer Centre
St. Andrews Place
East Melbourne VIC 3002
Country 234 0
Australia
Phone 234 0
+61 3 96561697
Fax 234 0
+61 3 96561408
Email 234 0
John.Seymour@petermac.org

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
SourceTitleYear of PublicationDOI
EmbaseA phase II study of a modified hyper-CVAD frontline therapy for patients with adverse risk diffuse large B-cell and peripheral T-cell non-Hodgkin lymphoma.2019https://dx.doi.org/10.1080/10428194.2018.1516873
N.B. These documents automatically identified may not have been verified by the study sponsor.