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 trial)

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 102

Inclusion Criteria

Patients with morphologically documented ALL who meet the following criteria;
1. 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
2. Patients with ALL in first CR
3. 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
4. Patients considered suitable to undergo a RIC allogeneic SCT as clinically judged by the Local Investigator including:
4.1. Adequate hepatic and renal function as determined by full blood count and biochemistry assessment
4.2. 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
4.3. Patients with abnormal cardiac and/or pulmonary function must be considered fit for allogeneic SCT including 8Gy of TBI at the time of randomisation.
5. Patients with an ECOG performance status 0,1 or 2
6. 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
7. Patients have given written informed consent
8. Patients willing and able to comply with scheduled study visits and laboratory tests

Exclusion Criteria

1. Patients with contraindications to receiving RIC allogeneic SCT
2. Female patients who are pregnant or breastfeeding. All women of childbearing potential (WOCBP) must have a negative pregnancy test before commencing treatment
3. Adults of reproductive potential not willing to use appropriate, effective, contraception during the specified period
4. Patients with renal or hepatic impairment as clinically judged by Local Investigator
5. Patients with active infection, HIV-positive or chronic active Hep-A or -C
6. 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS) defined as time from randomisation to the first of relapse or death from any cause. Patients who are still alive and progression free at the end of the trial will be censored at the date they were last known to be alive. Bone marrow assessments carried out to assess disease status at baseline, Day 100, Month 6/9/12/15/18/21/24/30/36

Secondary Outcome Measures

Name	Time	Method

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