Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000536662
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
28/09/2005
Date last updated
28/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase II study of allogeneic transplantation using transplant-lite conditioning regimes
Scientific title
Phase II study to assess the safety and efficacy of allogeneic transplantation using transplant-lite conditioning regimes (Fludarabine and Melphalan) in patients with a diagnosis of a haematological malignancy or metastatic renal cancer who are considered unsuitable for a standard conditioning regime due to age, poor physical status or previous exposure to high dose chemotherapy/radiotherapy.
Universal Trial Number (UTN)
Trial acronym
Transplant LITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic renal cancer 662 0
Haematological malignancy 663 0
Condition category
Condition code
Cancer 736 736 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fludarabine 25mg/kg day -7 to day -3 prior to Transplant Day 0.
Melphalan 120mg/m2 day -2 prior to Transplant Day 0.
Intervention code [1] 443 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 909 0
1. Day 100 transplant related mortality defined by death due to graft failure, conditioning related toxicity, acute GVHD or infection.
Timepoint [1] 909 0
At day 100.
Primary outcome [2] 910 0
2. Establishment of complete donor chimerism defined by VNTR (sex matched) or by VNTR and Y-chromosome FISH (sex mismatched)
Timepoint [2] 910 0
At Day 28, 56, 84, 180, 270 and 365.
Secondary outcome [1] 1763 0
1. Assess the speed and completeness of donor cell engraftment.
Timepoint [1] 1763 0
Measured at Day 28, 56, 84, 180, 270, 365.
Secondary outcome [2] 1764 0
2. Assess the transplant related morbidity.
Timepoint [2] 1764 0
Measured at Day 28, 56, 84, 180, 270, 365.
Secondary outcome [3] 1765 0
3. Assess the incidence and severity of graft versus host disease.
Timepoint [3] 1765 0
Measured at Day 28, 56, 84, 180, 270, 365.
Secondary outcome [4] 1766 0
4. Assess progression free and overall survival.
Timepoint [4] 1766 0
Measured at Day 28, 56, 84, 180, 270, 365.

Eligibility
Key inclusion criteria
Summary of Patient/Donor Eligibility Criteria:1. Diagnosis of haematological malignancy or metastatic renal cancer. 2. ECOG performance status 0-2. 3. Either a suitable HLA-identical sibling donor, fit for peripheral blood stem cell collection (cohort 1) or a suitable HLA-mismatched (single HLA mismatch) sibling donor, fit for peripheral blood stem cell collection, available HLA-identical (HLA-A,B,DRB1) unrelated donor or available HLA-mismatched (single HLA mismatch) unrelated donor (cohort 2).
Minimum age
Not stated
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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
Active, not recruiting
Date of first participant enrolment
Anticipated
3/03/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 817 0
Self funded/Unfunded
Name [1] 817 0
Country [1] 817 0
Primary sponsor type
Individual
Name
Dr James Morton
Address
Country
Secondary sponsor category [1] 683 0
Hospital
Name [1] 683 0
Royal Brisbane and Women's Hospital
Address [1] 683 0
Country [1] 683 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2083 0
Bone Marrow Transplant Unit, Royal Brisbane and Women's Hospital
Ethics committee address [1] 2083 0
Ethics committee country [1] 2083 0
Australia
Date submitted for ethics approval [1] 2083 0
Approval date [1] 2083 0
Ethics approval number [1] 2083 0
Ethics committee name [2] 2084 0
Bone Marrow and Stem Cell Transplant Unit, Royal Children's Hospital
Ethics committee address [2] 2084 0
Ethics committee country [2] 2084 0
Australia
Date submitted for ethics approval [2] 2084 0
Approval date [2] 2084 0
Ethics approval number [2] 2084 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36000 0
Address 36000 0
Country 36000 0
Phone 36000 0
Fax 36000 0
Email 36000 0
Contact person for public queries
Name 9632 0
Mrs Robyn Western
Address 9632 0
Cancer Care Clinical Trials
Bone Marrow Transplantation (BMT) Department
Royal Brisbane and Women's Hospital
Level 5
Joyce Tweddell Building
Butterfield Street
Herston Brisbane QLD 4029
Country 9632 0
Australia
Phone 9632 0
+61 7 36365378
Fax 9632 0
Email 9632 0
[email protected]
Contact person for scientific queries
Name 560 0
Dr James Morton
Address 560 0
Bone Marrow Transplantation (BMT) Unit
Cancer Care Services
Royal Brisbane and Women's Hospital
Level 5 Joyce Tweddell Building
Butterfield Street
Herston Brisbane QLD 4029
Country 560 0
Australia
Phone 560 0
+61 7 36368111
Fax 560 0
Email 560 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
No additional documents have been identified.