Status:
COMPLETED
Clofarabine Pre-conditioning With Allogeneic Transplant for Acute Myeloid Leukaemia (AML)
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Acute Myeloid Leukaemia
Myelodysplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study has been designed to investigate the safety and feasibility of using a chemotherapy drug, Clofarabine, to reduce the disease burden before a donor transplant, in patients with high risk Acu...
Detailed Description
This is a pilot study. Twenty patients in total will be treated in two cohorts of 10 patients each. * Cohort One: Patients suitable for full intensity conditioning will receive Clofarabine pre-condit...
Eligibility Criteria
Inclusion
- Cytologically and immunophenotypically (or immunohistochemically) confirmed diagnosis of high risk AML or MDS
- Minimum age of 18 years
- Eligible for allogeneic stem cell transplant by local institutional guidelines
- Suitable matched-related/sibling or volunteer unrelated donor available, as determined by local institutional guidelines
- Negative pregnancy test for females of child-bearing potential within 7 days prior to the start of study treatment
- If sexually active, male and female subjects must agree that they will use an effective method of birth control throughout the active study period
- Written informed consent
- Capable of and willing to comply with scheduled visits, treatment plan and required laboratory tests
- Adequate renal and hepatic function
Exclusion
- Psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
- Previous Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplant.
- Pregnant or lactating women. All female subjects of child-bearing potential must have a negative pregnancy test within 7 days prior to the start of treatment.
- Any current active, invasive malignancy excluding AML or MDS
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01422603
Start Date
February 1 2011
End Date
March 31 2015
Last Update
September 7 2018
Active Locations (1)
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1
Wessex Blood and Marrow Transplant Unit, Southampton University Hospitals NHS Trust
Southampton, Hampshire, United Kingdom, SO16 6YD