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

niversity of Birmingham0 sites102 target enrollmentJanuary 25, 2019

ConditionsAcute lymphoblastic leukaemia Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Acute lymphoblastic leukaemia
Sponsor: niversity of Birmingham
Enrollment: 102
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2023 Protocol article in https://doi.org/10.1136/bmjopen-2022-067790 (added 02/06/2023)

Registry

who.int

Start Date

January 25, 2019

End Date

November 22, 2027

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity of Birmingham

Eligibility Criteria

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

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