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Trial registered on ANZCTR


Registration number
ACTRN12605000380695
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
13/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Induction Of Mixed Haematopoietic Chimerism In Patients Using Fludarabine, Low Dose Total Body Irradiation, Peripheral Blood Stem Cell Infusion And Post-Transplant Immunosuppression With Cyclosporine And Mycophenolate Mofetil
Scientific title
Evaluation of Donor/Recipient Chimerism and graft rejection in patients who have undergone a Peripheral Blood Stem Cell allograft following Fludarabine and Low dose Total Body Irradiation as a non-myeloablative conditioning regimen.
Universal Trial Number (UTN)
Trial acronym
Flu TBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic syndromes. 475 0
Myeloproliferative syndromes. 476 0
Acute Leukemia with < 10% blasts. 477 0
Amyloidosis 478 0
Hodgkins disease. 479 0
Multiple Myeloma 480 0
Non-Hodgkins lymphoma 481 0
Chronic myeloid leukaemia 482 0
Chronic lymphocytic leukaemia 483 0
Renal cell carcinoma 484 0
Condition category
Condition code
Blood 554 554 0 0
Other blood disorders
Cancer 555 555 0 0
Leukaemia - Acute leukaemia
Other 556 556 0 0
Other blood disorders
Cancer 557 557 0 0
Hodgkin's
Cancer 558 558 0 0
Myeloma
Cancer 559 559 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 560 560 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 562 562 0 0
Leukaemia - Chronic leukaemia
Cancer 563 563 0 0
Renal Cell Carcinoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is planned to test the hypothesis that we can reliably establish mixed chimerism in humans using a non-myeloablative regimen and that we can decrease the incidence of graft rejection by the addition of 3 doses of fludarabine (30 mg/m2 given days -4, -3, -2) before 200 cGy TBI. Mixed chimerism will be defined as the detection of donor cells after transplant at > than 1% and <= 95% of the eripheral blood CD3+ cell population. Patients with low levels of T cell chimerism or those with continued evidence of malignancy (without GVHD) will be evaluated for the effects of DLI on conversion to full chimerism and for anti-tumour activity. The source of stem cells will be G-CSF mobilised PBSC from apheresis products collected on two consecutive days infused into the patient on day 0. Donor lymphocyte infusions may be given starting 2 months post-transplant in an attempt to convert mixed chimerism to full donor chimerism and to eradicate the malignancy. A graded series of T cell doses will be employed to reduce the risks of severe GVHD. For unrelated donor transplants, Bone Marrow will be used a the stem cell source if PBSC is not available.
Intervention code [1] 417 0
Treatment: Drugs
Comparator / control treatment
Control group
Historical

Outcomes
Primary outcome [1] 646 0
To estimate the risk of graft rejection associated with the addition of fludarabine to a non-myeloablative conditioning regimen for patients with malignant diseases treatable by allogeneic stem cell transplantation and compare this rate to that observed among patients previously treated without fludarabine.
Timepoint [1] 646 0
Secondary outcome [1] 1338 0
To estimate the rate of grade acute II/IV GVHD and chronic GVHD in patients treated with low-dose TBI, Fludarabine, PBSC infusion and immunosuppression with Cyclosporine and Mycophenolate Mofetil.
Timepoint [1] 1338 0

Eligibility
Key inclusion criteria
Patients with haematological malignancy or metastatic renal cancer who are not eligible for a curative autologous transplantation or who have failed prior autologous transplantation and are not suitable for ablative conditioning regimes due to a high risk of treatment related morbidity/mortality (eg age, prior autologous transplant, pre-existing medical conditions). Patients with NHL and CLL must have failed prior therapy with an alkylating agent and/or fludarabine, or be at high risk of relapse. Patients with multiple myeloma must have stage II or III disease and received prior chemotherapy.
Minimum age
Not stated
Maximum age
Not stated
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 612 0
Self funded/Unfunded
Name [1] 612 0
Address [1] 612 0
Country [1] 612 0
Primary sponsor type
Individual
Name
A/Prof Durrant
Address
Country
Secondary sponsor category [1] 499 0
Hospital
Name [1] 499 0
Royal Brisbane and Women's Hospital
Address [1] 499 0
Country [1] 499 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1705 0
Bone Marrow Transplant Unit - Royal Brisbane and Women's Hospital
Ethics committee address [1] 1705 0
Ethics committee country [1] 1705 0
Australia
Date submitted for ethics approval [1] 1705 0
Approval date [1] 1705 0
Ethics approval number [1] 1705 0
Ethics committee name [2] 1706 0
Bone Marrow and Stem Cell Transplant Unit - Royal Children's Hospital
Ethics committee address [2] 1706 0
Ethics committee country [2] 1706 0
Australia
Date submitted for ethics approval [2] 1706 0
Approval date [2] 1706 0
Ethics approval number [2] 1706 0

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

Contacts
Principal investigator
Name 35342 0
Address 35342 0
Country 35342 0
Phone 35342 0
Fax 35342 0
Email 35342 0
Contact person for public queries
Name 9606 0
Mrs Robyn Western
Address 9606 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 9606 0
Australia
Phone 9606 0
+61 7 36365378
Fax 9606 0
Email 9606 0
Robyn_Western@health.qld.gov.au
Contact person for scientific queries
Name 534 0
Associate Professor Simon Durrant
Address 534 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 534 0
Australia
Phone 534 0
+61 7 36368111
Fax 534 0
Email 534 0
Simon_Durrant@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary