Acute Lymphoblastic Leukaemia (ALL) MedDRA version: 20.1 Level: LLT Classification code 10000844 Term: Acute lymphoblastic leukaemia System Organ Class: 100000004864
Conditions
Interventions
Product Name: Cyclophosphamide
Product Code: Cyclophosphamide
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: cyclophosphamide
CAS Number: 50-18-0
Current Sponsor code: Cycl
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principle objective of the trial is to determine whether there is a difference in the disease free survival (DFS) of patients with ALL after a TBI and cyclophosphamide transplant compared with patients receiving the standard fludarabine/melphalan transplant regimen. ;Secondary Objective: The secondary objectives are are to determine whether there is a difference between overall survival, cumulative incidence of disease relapse, non relapse mortality, incidence of grade 2-4 acute GvHD, incidence of chronic GvHD of any grade, occurrence and severity of veno-occlusive disease, duration of hospitalisation in the first year and quality of life (QoL), full donor chimerism at day 100 and TBI related symptomatic pulmonary toxicity between the two treatment groups.;Primary end point(s): To determine the disease free survival (DFS) of patients with acute lymphoblastic leukaemia (ALL) after a total body irradiation and cyclophosphamide allograft compared with patients using fludarabine and melphalan reduced intensity conditioning regimen.;Timepoint(s) of evaluation of this end point: Patients will be followed up for 36 months to assess disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare transplant outcome between the control and experimental arm in terms of overall survival (OS, Cumulative incidence of relapse (CIR), Non relapse mortality (NRM), incidence of Grade 2-4 acute GvHD, incidence of chronic GvHD of any grade, occurrence and severity of veno-occlusive disease (VOD), duration of hospitalisation in the first year, quality of life (QoL), full donor chimerism at Day 100 and TBI related symptomatic pulmonary toxicity following allogeneic transplantation. ;Timepoint(s) of evaluation of this end point: Patients will be followed up for 36 months to assess the secondary endpoints of the study. | — |
Countries
United Kingdom
Contacts
Public ContactDr David Marks
Bristol Haematology and Oncology Centre
Outcome results
None listed