Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000373572
Ethics application status
Approved
Date submitted
4/08/2006
Date registered
25/08/2006
Date last updated
3/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outpatient Ifosfamide, Etoposide plus Rituximab (R-IE) for salvage in patients > 60 years with relapsed or refractory CD20 positive diffuse large B-cell lymphoma who are not candidates for stem cell transplant study
Scientific title
A phase IV study to evaluate the treatment response (Complete Response [CR]and Partial Response [PR] of out-patient Ifosfamide, Etoposide plus Rituximab (R-IE) for salvage in patients >60 years with relapsed or refractory CD20 positive diffuse large B-cell lymphoma who are not candidates for stem cell transplant
Universal Trial Number (UTN)
Trial acronym
R-IE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or refractory CD20 positive diffuse large B-cell lymphoma 1341 0
Condition category
Condition code
Cancer 1429 1429 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rituximab 375 mg/m2 iv on day 1
Ifosfamide 5,000 mg/m2 iv in equally divided doses over 3 days (days 1-3)
Etoposide 100 mg/m2 iv daily for days 1 to 3
Pegfilgrastim 6 mg subcutaneous (SC) on day 4
6 cycles (21 days in each cycle)
Intervention code [1] 1064 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1955 0
To evaluate overall treatment response (Complete Response (CR) and Partial Response(PR)) of an outpatient-based fractionated salvage regimen consisting of ifosfamide, etoposide plus rituximab (R-IE) given every three weeks in patients > 60 years with relapsed or refractory CD20 positive diffuse large B-cell lymphoma and who are not considered eligible for stem cell transplantation.
Timepoint [1] 1955 0
To be assessed after Cycle 3 & 6.
Secondary outcome [1] 3423 0
To evaluate overall survival
Timepoint [1] 3423 0
Every 3 months following completion of 6 cycles of therapy for 5 years.
Secondary outcome [2] 3424 0
To evaluate event free survival
Timepoint [2] 3424 0
Every 3 months following completion of 6 cycles of therapy for 5 years.
Secondary outcome [3] 3425 0
To evaluate the safety profile
Timepoint [3] 3425 0
After each cycle of therapy
Secondary outcome [4] 3426 0
To evaluate the haematological toxicity (grades 3/4 neutropenia and thrombocytopenia).
Timepoint [4] 3426 0
After each cycle of therapy

Eligibility
Key inclusion criteria
1. Eastern Oncology Co-operative Group (ECOG) performance status 0 to 2. 2. Relapsed or progressive Cluster Designation 20 (CD20) positive diffuse large B-cell lymphoma including induction failures to first-line anthracycline-containing regimens and not usually considered eligible for high dose chemotherapy and stem cell transplantation. 3. Able to give written informed consent. 4. Life expectancy ³ 3 months
Minimum age
60 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of severe cardiac, hepatic, respiratory, or renal disease. 2. Poor renal function (serum creatinine > 150 µmol/L or 1.5-2.0 x Upper Limit Normal (ULN), poor hepatic function (bilirubin >30 µmol/L or >1.5x ULN; transaminases>2.5 x ULN) unless these abnormalities are related to lymphoma. 3. Poor bone marrow reserve as defined by neutrophils <1.5 x 109/L or platelets <100 x 109/L unless related to bone marrow infiltration. 4. Pregnant women or breast-feeding mothers. 5. Known hypersensitivity to E coli proteins, or with known anaphylaxis or IgE-mediated hypersensitivity to murine proteins, or to any component of the drugs being used. 6. Unable to provide written informed consent.

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 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1560 0
Commercial sector/Industry
Name [1] 1560 0
Roche
Country [1] 1560 0
Funding source category [2] 1561 0
Commercial sector/Industry
Name [2] 1561 0
Amgen & Baxter
Country [2] 1561 0
Primary sponsor type
Commercial sector/Industry
Name
Roche
Address
Country
Switzerland
Secondary sponsor category [1] 1373 0
Commercial sector/Industry
Name [1] 1373 0
Amgen & Baxter
Address [1] 1373 0
Country [1] 1373 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2992 0
Westmead Hospital
Ethics committee address [1] 2992 0
Ethics committee country [1] 2992 0
Date submitted for ethics approval [1] 2992 0
Approval date [1] 2992 0
25/11/2005
Ethics approval number [1] 2992 0
2005/9/4.7(2186)
Ethics committee name [2] 2993 0
Concord Hospital
Ethics committee address [2] 2993 0
Ethics committee country [2] 2993 0
Date submitted for ethics approval [2] 2993 0
Approval date [2] 2993 0
Ethics approval number [2] 2993 0
CH62/6/2006-005

Summary
Brief summary
Patients with relapsed or refractory lymphoma require initial salvage chemotherapy to control their disease. One type of salvage chemotherapy is Rituximab, Ifosfamide and Etoposide (R-IE) given for six cycles administered every 21 days, followed by two additional doses of Rituximab at intervals of 21 days. Ifosfamide and Etopside are given on days 1 to 3 and Rituximab is given on day 1. On the day following each cycle of the R-IE therapy (day 4) a single injection under the skin of pegfilgrastim is given to prevent the white blood cell count from falling too low and therefore reduce the number of infections the patient may experience.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35711 0
Address 35711 0
Country 35711 0
Phone 35711 0
Fax 35711 0
Email 35711 0
Contact person for public queries
Name 10253 0
Angela Bayley
Address 10253 0
Deparment of Clinical Haematology
Westmead Hospital
Westmead NSW 2145
Country 10253 0
Australia
Phone 10253 0
+61 2 98457219
Fax 10253 0
+61 2 96893700
Email 10253 0
[email protected]
Contact person for scientific queries
Name 1181 0
Mark Hertzberg
Address 1181 0
Deparment of Clinical Haematology
Westmead Hospital
Westmead NSW 2145
Country 1181 0
Australia
Phone 1181 0
+61 2 98457610
Fax 1181 0
+61 2 96892331
Email 1181 0
[email protected]

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
EmbaseEfficacy of Salvage Treatments in Relapsed or Refractory Diffuse Large B-Cell Lymphoma Including Chimeric Antigen Receptor T-Cell Therapy: A Systematic Review and Meta-Analysis.2023https://dx.doi.org/10.4143/crt.2022.1658
EmbaseOutpatient rituximab, ifosfamide, etoposide (R-IE) in patients older than 60 years with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for stem cell transplantation.2020https://dx.doi.org/10.1080/10428194.2019.1660968
N.B. These documents automatically identified may not have been verified by the study sponsor.