A Phase 1/2 interventional study of Clofarabine and Clofarabine in Acute Myeloid Leukaemia and Myelodysplasia, sponsored by University Hospital Southampton NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-07.
Sponsored by University Hospital Southampton NHS Foundation Trust · Phase 1/2, Interventional, and Treatment
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 Acute Myeloid Leukaemia or Myelodysplasia (MDS). In this study Clofarabine chemotherapy will be given a few days before a reduced or full intensity donor stem cell transplant and without waiting for normal blood counts to recover. It is hoped that this approach may improve the outcome for patients with high risk AML and MDS after their transplant.
This is a pilot study. Twenty patients in total will be treated in two cohorts of 10 patients each.
The cohorts will be recruited concurrently. It is anticipated that recruitment of the 20 subjects will be achieved in 18 months to two years.
The study will be conducted at a single centre (Southampton, UK) in the first instance.
This design allows the use of a full intensity, TBI-based transplant conditioning schedule, for younger patients able to tolerate this approach but also the use of a reduced intensity transplant conditioning schedule in older or less fit patients who may still benefit from pre-conditioning with Clofarabine followed by an allogeneic stem cell transplant. This design, therefore, does not restrict potential recruitment to the study on age or performance status alone (within the limits set by ability to tolerate intensive chemotherapy and a transplant procedure).
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 9 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →University Hospital Southampton NHS Foundation Trust is the lead sponsor of 147 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Cohort One: Patients suitable for full intensity conditioning will receive Clofarabine pre-conditioning followed by a Cyclophosphamide and Total Body Irradiation conditioned allogeneic stem cell transplant (SCT).
Drug: Clofarabine
Cohort 2: Patients not suitable for a full intensity TBI-based transplant due to age or co-morbidity will receive Clofarabine pre-conditioning followed by a reduced intensity allogeneic stem cell transplant using Fludarabine, intravenous Busulphan and Campath 1H.
Drug: Clofarabine
Clofarabine preconditioning (40mg/m2 daily for 5 days) prior to full intensity allogeneic stem cell transplant
Clofarabine preconditioning (40mg/m2 daily for 5 days) prior to reduced intensity allogeneic stem cell transplant
Treatment related mortality (TRM)
Treatment related mortality (TRM) measured at day 100 and 1 year post transplant and cause of mortality
Time frame: day 100 and 1 year post transplant
Overall survival (OS)
Time frame: 1 year post transplant
Event free survival (EFS)
Time frame: 1 year post transplant
Efficacy of Clofarabine as a leukaemia bulk-reducing agent prior to transplant conditioning
Efficacy of Clofarabine as a leukaemia bulk-reducing agent prior to transplant conditioning as determined by pre- and post-Clofarabine bone marrow biopsy examination
Time frame: Within 4 weeks prior to Clofarabine and 1 to 5 days following Clofarabine
Time to engraftment
Time frame: by day 100 post transplant
Donor/recipient chimerism
Time frame: day 30, day 100 and 1 year post transplant
Immune reconstitution parameters (T, B and NK cell subsets)
Time frame: day 30, day 100 and 1 year post transplant
Duration of hospital stay
Duration of in patient hospital stay for Clofarabine preconditioning chemotherapy and stem cell transplant
Time frame: The duration of hospital stay will be measured, an expected average of 7 to 8 weeks
Incidence of acute and chronic graft versus host disease
Time frame: 1 year post transplant
Grade of acute and chronic graft versus host disease
Time frame: 1 year post transplant
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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University Hospital Southampton NHS Foundation Trust