FLAMSA-BU conditioning regimen in patients with acute myeloid leukaemia and myelodysplasia undergoing allogeneic stem cell transplantatio

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (acute myeloid); Cancer; Other myeloid leukaemia

• Registration Number: ISRCTN50855000
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2019 Abstract results in https://doi.org/10.1182/blood-2019-125646 Presented at ASH (added 12/05/2022) 2021 Results article in https://dx.doi.org/10.1200/JCO.20.02308 (added 12/05/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-11
• Study Completion: 2015-10-31
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 244

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
1.1. Patients in 1st complete remission (CR1) with adverse risk cytogenetics
1.2. Patients in 2nd complete remission (CR2)
1.3. Patients with primary refractory AML defined as the failure to achieve a morphological remission after 2 courses of induction chemotherapy
1.4. 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)
1.5. 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
1.6. Patients with advanced MDS (defined by an IPSS score of INT1 with >5% blasts or INT2 or high risk ) who have < 5% blasts at the time of randomisation following chemotherapy or hypomethylating agents if necessary
2. Patients aged = 16 years
3. Patients with an HLA identical sibling or suitable matched unrelated donor (suitable match defined as no greater
than a single allele mismatch at HLA A, B, C or DRB1)
4. Patients considered suitable to undergo a reduced intensity conditioned allogeneic stem cell transplant as clinically judged by the Local Investigator including:
4.1. Adequate cardiac, pulmonary, hepatic and renal function as determined by pre-transplant assessments
4.2. Resolution of any toxic effects of prior therapy (including radiotherapy, chemotherapy or surgical procedures)
5. Patients with an ECOG performance status of 0, 1 or 2
6. Patients have given written informed consent
7. Patients willing and able to comply with scheduled study visits and laboratory tests

Exclusion Criteria

1. Patients with chemorefractory 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival, measured using date of death from any cause; Timepoints: 24 months post transplant

Secondary Outcome Measures

Name	Time	Method
<br> 1. Disease relapse, measured using date of relapse; Timepoint(s): Disease relapse within the 24 month follow up<br> 2. Event free survival, measured using date of relapse or date of death; Timepoint(s): 24 months post transplant<br> 3. Incidence of graft versus host disease (GvHD), measured counting episodes of GvHD; Timepoint(s): Throughout the 24 month follow up<br> 4. Quality of Life; Timepoint(s): FACT-BMT questionnaire, completed pre-tranplant, at day 42 and month 3, 6, 9, 12, 18 and 24.<br> 5. Transplant related mortality measured by any death related to transplant procedure, not underlying, disease at day 100 and 12 months post-transplant<br>