A comparison of two low-intensity transplant regimens for the treatment of adults with acute lymphoblastic leukaemia (ALL) over the age of 40 years (ALL-RIC)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 242

Inclusion Criteria

Patients with morphologically documented ALL who meet the following criteria;
• Patients between the ages of 40-65 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 CR
• Availability of a human leukocyte antigen (HLA) identical sibling or suitable matched unrelated donor (suitable matched defined as no greater than a single allele mismatch at HLA A, B, C or DRß1). 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:-
o Adequate hepatic and renal function as determined by full blood count and biochemistry assessment
o 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
o 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
• Female 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
• Patients have given written informed consent
• Patients willing and able to comply with scheduled study visits and laboratory tests

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• Patients with contraindications to receiving RIC allogeneic SCT
• 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 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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