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)

Trial summary:

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 (SCT) comparing the novel conditioning regimen of TBI and cyclophosphamide with the standard condition of Fludarabine/Melphalan/Alemtuzumab (FMA). Patients will be stratified at randomisation by the donor type (sibling; unrelated) and by age (above; below 55 years of age). The trial aims to compare disease free survival at 2 years of patients with ALL after a TBI and cyclophosphamide allograft with that of patients transplanted using the FMA conditioning regimen

RT QA summary:

All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss

QA ProcessQA ActivityRequired for TrialAdditional Details
Pre-AccrualFacility Questionnaire
Outlining Benchmark Case
Planning Benchmark Case
Dummy Run
During AccrualIndividual Case Review
Data collection
TBI Survey
QA Streamlining

RTTQA contact:

Chief investigator: Professor David Marks, Bristol Haematology and Oncology Centre

Sponsor: University of Birmingham.

Funder: Anthony Nolan, Leuka & Blood and Transplant