close help
scroll up   scroll up
Australian New Zealand Clinical Trials Registry
Home Login Contact us Feedback
Australian New Zealand Clinical Trials Registry
Register Trial Trial Search Latest News FAQ About Us

Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 000469
ACTR Number: ACTRN12605000380695
Trial Status: Registered
Date Submitted: 8/09/2005
Date Registered: 13/09/2005

Page 1

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
ANZCTR registration 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.
Secondary ID: 
UTN:
Trial acronym: Flu TBI

Page 2

Health condition(s) or problem(s) studied:
Myelodysplastic syndromes. 
Myeloproliferative syndromes. 
Acute Leukemia with < 10% blasts. 
Amyloidosis 
Hodgkins disease. 
Multiple Myeloma 
Non-Hodgkins lymphoma 
Chronic myeloid leukaemia 
Chronic lymphocytic leukaemia 
Renal cell carcinoma 
Condition category: Condition code:
Blood Other blood disorders 
Cancer Leukaemia - Acute leukaemia 
Other Other blood disorders 
Cancer Hodgkin's 
Cancer Myeloma 
Cancer Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma 
Cancer Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma 
Cancer Leukaemia - Chronic leukaemia 
Cancer Renal Cell Carcinoma 

Page 3

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:Treatment: drugs 
Comparator / control treatment:
Control group: Historical

Page 4

Primary outcome: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: 
Secondary outcome: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: 

Page 5

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
Healthy volunteers? No
Key exclusion criteria: No exclusion criteria

Page 6
Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Nonrandomised trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Masking / blinding: Open (masking not used)
Assignment: Single group
Other design features (specify):
Type of endpoint(s): Safety/efficacy

Page 7
Phase Phase 2
Anticipated or actual date of first participant enrolement: 19/01/2001
Target sample size: 40
Recruitment status: Closed: follow-up continuing

Page 8

Funding source:Self funded/Unfunded 
Name: 
Address: 
Country: 
Primary sponsor: Individual
Name: A/Prof Durrant
Address:
Country:
Secondary sponsor:Hospital 
Name:Royal Brisbane and Women's Hospital 
Address: 
Country:Australia 
Other collaborator: 

Page 9

Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:Bone Marrow Transplant Unit - Royal Brisbane and Women's Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 2:Bone Marrow and Stem Cell Transplant Unit - Royal Children's Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Countries of recruitment:Australia 
Brief summary:
Trial website:
Presentations / publication list:

Page 10

Contact person for public queries
Name: Mrs Robyn Western
Address: 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: Australia
Tel: +61 7 36365378
Fax:
Email: Robyn_Western@health.qld.gov.au

Contact person for scientific queries
Name: Associate Professor Simon Durrant
Address: 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: Australia
Tel: +61 7 36368111
Fax:
Email: Simon_Durrant@health.qld.gov.au

Contact person responsible for updating information
Name:
Address:
Country:
Tel:
Fax:
Email:
   
© 2007 ANZCTR Terms and Conditions Privacy      Design by Symbiation