A Comparison of Reduced Dose Total Body Irradiation (TBI) and Cyclophosphamide With Fludarabine and Melphalan Reduced Intensity Conditioning in Adults With Acute Lymphoblastic Leukaemia (ALL) in Complete Remission. (ALL-RIC)

Prior treatment

• Patients with contraindications to receiving RIC allogeneic SCT
• Previous exposure to a high dose of radiotherapy

Other illness

• Patients with renal or hepatic impairment as clinically judged by Local Investigator
• Patients with active infection, HIV-positive or chronic active Hep-A or -C
• Patients with concurrent active malignancy. Patients with a previous history of malignancy can be included if that malignancy is considered to be at a low risk of recurrence

Other

• Female patients who are pregnant or breastfeeding. All women of childbearing potential (WOCBP) must have a negative pregnancy test before commencing treatment
• Adults of reproductive potential not willing to use appropriate, effective, contraception during the specified period

• Patients between the ages of 40-70 years. NB: Patients under the age of 40 who are considered unsuitable for a myeloablative transplant may enrol onto the trial following discussion with the CI via the Trials Office
• Patients with ALL in first or second CR
• Availability of a human leukocyte antigen (HLA) identical sibling or suitable matched donor (suitable matched defined as no greater than a single allele mismatch at HLA A, B, C or DRβ1). A single allele mismatch is permitted if there are adverse cytogenetics or MRD positivity at any timepoint
• Patients considered suitable to undergo a RIC allogeneic SCT as clinically judged by the Local Investigator including:-
  • Adequate hepatic and renal function as determined by full blood count and biochemistry assessment
  • Resolution of any toxic effects of prior therapy (including radiotherapy, chemotherapy or surgical procedures). Patients with bone marrow suppression following therapy may enter the trial
  • Patients with abnormal cardiac and/or pulmonary function must be considered fit for allogeneic SCT including 8Gy of TBI at the time of randomisation.
• Patients with an ECOG performance status 0,1 or 2
• Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must use appropriate, highly effective, contraception from the point of admission for transplant conditioning therapy until 12 months after transplant (see section 8.1.2.2)
• Patients have given written informed consent
• Patients willing and able to comply with scheduled study visits and laboratory tests