Acute Myeloid Leukaemia (AML) and Myelodysplasia (MDS) MedDRA version: 14.1 Level: LLT Classification code 10028532 Term: Myelodysplasia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Campath
Product Name: Alemtuzumab
Product Code: Alemtuzumab
Pharmaceutical Form: Injection
INN or Proposed INN: Alemtuzumab
CAS Number: 216503-57-0
Current Sponsor code: Alemtuzumab
Concen
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with a morphologically documented diagnosis of AML or MDS clinically indicated to receive a RIC allograft with one the following disease characteristics: AML - Patients in 1st complete remission (CR1) with adverse risk cytogenetics - Patients in 2nd complete remission (CR2) - Patients with primary refractory AML defined as the failure to achieve a morphological remission after 2 courses of induction chemotherapy - Patients participating in the UK NCRN AML17 (or the subsequent AML19) clinical trial who have been defined as high risk (based upon age, de novo or secondary disease, cytogenetics, white blood count, sex and response to course 1) - Patients participating in the UK NCRN AML17, AML18 (or the subsequent AML19) clinical trials who have been defined as high risk by Minimal Residual Disease (MRD) criteria MDS - Patients with advanced MDS (defined by an IPSS score of INT-1 with >5% blasts or INT-2 or high risk ) who have =65 years) no F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1) Patients with chemo-refractory relapse of AML or MDS 2) Patients with contraindications to receiving RIC allogeneic SCT 3) Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before commencing treatment 4) Adults of reproductive potential not willing to use appropriate, effective, contraception during the specified period 5) Patients with clinically significant cardiac disease (New York Heart Association, Class III or IV) 6) Patients with renal or hepatic impairment as clinically judged by Local Investigator 7) Patients with active infection, HIV-positive or chronic active Hep-A, -B, -C 8) Patients with concurrent active malignancy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare transplant outcome between the control and experimental arm in terms of disease-free survival (DFS), disease relapse, transplant related mortality (TRM) and quality of life (QoL) following allogeneic transplantation.;Timepoint(s) of evaluation of this end point: Patients will be followed up for 24 months to assess the secondary endpoints of the study. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of the trial is to determine whether there is a difference in the overall survival (OS) of patients with high risk AML/MDS after a FLAMSA-BU transplant compared with patients receiving one of the three currently used transplant regimens (FMA/FBA/FB-ATG). ;Secondary Objective: The secondary objectives are to determine whether there is a difference between event-free survival, rates of disease relapse, incidence of graft-versus-host-disease, transplant related deaths, and quality of life between the two treatment groups. ;Primary end point(s): To determine the overall survival (OS) of patients with high risk AML and MDS after a FLAMSA-BU allograft compared with patients transplanted using either fludarabine/melphalan/alemtuzumab (FMA) or fludarabine/busulphan/alemtuzumab (FBA)or fludarabine/busulphan/ATG (FB-ATG) conditioning regimens. ;Timepoint(s) of evaluation of this end point: Patients will be followed up for 24 months to assess overall survival. | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Charles Craddock
CRUK Clinical Trials Unit
Outcome results
None listed