FLAMSA-BU conditioning regimen in patients with acute myeloid leukaemia and... | Not Recruiting
FLAMSA-BU conditioning regimen in p... | Not Recruiting
FLAMSA-BU conditioning regimen in patients with acute myeloid leukaemia and myelodysplasia undergoing allogeneic stem cell transplantation
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Medical Conditions
  • Topic: National Cancer Research Network
  • Subtopic: Haematological Oncology
  • Disease: Leukaemia (acute myeloid)
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN50855000
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-different-combinations-of-drugs-before-a-stem-cell-transplant-for-aml-or-mds-figaro
Research Details
  • This is a prospective, phase II, multicentre, randomised clinical trial in patients with acute myeloid leukaemia (AML) or myelodysplasia (MDS) undergoing reduced intensity conditioning (RIC) allogeneic stem cell transplantation (SCT) comparing the novel conditioning regimen (fludarabine/cytarabine/amsacrine/busulphan/ATG) (FLAMSA-BU) with standard conditioning regimens fludarabine/melphalan/alemtuzumab (FMA), fludarabine/busulphan/alemtuzumab (FBA) or fludarabine/busulphan/ATG (FB-ATG).
Phase
Phase II
Study Design
Randomised interventional treatment trial
Study Type
Interventional
Intervention

Patients will be stratified at randomisation by their underlying disease (AML; MDS), cytogenetic risk group (adverse risk; intermediate or good risk), disease status at transplant [1st complete remission (CR1) or 2nd complete remission (CR2)]; primary refractory disease, intended control arm regimen (FMA; FBA; FB-ATG), age (above; below 60 years of age) and by donor type (sibling; unrelated).

Patients eligible for entry into the trial will be randomised on a 1:1 basis

Standard conditioning regimens fludarabine/melphalan/alemtuzumab (FMA), fludarabine/busulphan/alemtuzumab (FBA) or fludarabine/busulphan/ATG (FB-ATG).

Novel conditioning regimen, Using fludarabine, cytarabine, amsacrine, busulphan and ATG combined to condition the patients for a reduced intensity stem cell transplant.

The interventions are from 7 to 12 days depending in which treatment arm is selected. The follow-up is 24 months for both arms.

Study Entry : Single Randomisation only

Intervention Type
Drug
Primary Outcome Measures
    Overall survivial, measured using date of death from any cause; Timepoints: 24 months post transplant
Secondary Outcome Measures
    1. Disease relapse, measured using date of relapse; Timepoint(s): Disease relapse within the 24 month follow up
    2. Event free survival, measured using date of relapse or date of death; Timepoint(s): 24 months post transplant
    3. Incidence of graft versus host disease (GvHD), measured counting episodes of GvHD; Timepoint(s): Throughout the 24 month follow up
    4. Quality of Life; Timepoint(s): FACT-BMT questionnaire, completed pre-tranplant, at day 42 and month 3, 6, 9, 12, 18 and 24.
    5. Transplant related mortality measured by any death related to transplant procedure, not underlying, disease at day 100 and 12 months post-transplant
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
UK Sample Size: 170
Participant 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
Participant 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Pfizer Investigational Site
Birmingham
B15 2TT
Trial Contact(s)
Primary Trial Contact
Dr Sarah Essex
-
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A randomised trial of the FLAMSA-BU conditioning regimen in patients with acute myeloid leukaemia and myelodysplasia undergoing allogeneic stem cell transplantation
EudraCT Number
2012-005538-12
Funder(s)
  • Leukaemia and Lymphoma Research
  • Grant Codes: 12071
Other Study ID Numbers
14772
Sponsor(s)
University of Birmingham (UK)
Key Dates

Recruitment Start Date

10 Oct 2013

Recruitment End Date

31 Oct 2015

Trial Start Date

10 Oct 2013

Trial End Date

31 Oct 2015

Date added to source

11 Oct 2013

Date updated in source

09 Nov 2017