Clofarabine Pre-conditioning With Allogeneic Transplant for Acute Myeloid Leukaemia (AML)

• Status: Completed
• Trial end date: 2015-03-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Southampton NHS Foundation Trust
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Clofarabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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