Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
University of Birmingham
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
40-70 years
Phase:
PHASE2
Brief Summary
The current national acute lymphoblastic leukaemia (ALL) trial in adults investigated whether a low (reduced) intensity chemotherapy regimen prior to transplant could improve the outcome of patients w...
Detailed Description
TRIAL SYNOPSIS Trial Design This is a 2 arm, phase II, multicentre, randomised clinical trial in adult patients with ALL in complete remission (CR) undergoing allogeneic stem cell transplantation (SC...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Previous exposure to a high dose of radiotherapy
Key Trial Info
Start Date :
November 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 22 2027
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT03821610
Start Date
November 22 2018
End Date
November 22 2027
Last Update
May 16 2024
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
Heart of England Nhs Foundation Trust
Birmingham, United Kingdom, B95ST
2
University Hospitals Birmingham Nhs Foundation Trust
Birmingham, United Kingdom
3
University Hospitals Bristol Nhs Foundation Trust
Bristol, United Kingdom, BS13NU
4
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom, CB20QQ