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Clinical picture: AML (Acute Myeloide Leukemia)
Trial: HOVON 93 AML / EBMT
News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms
News
HO93 news
As per Thursday, 20 October 2016 the HOVON-93 study will be closed for inclusion of new patients for Dutch Centers. It was decided to close the study prematurely because of the low inclusion.
Please inform your local staff that patients, who have signed already informed consent, can still be included in the study.
Please contact Marlies Groenendijk when you have a patient that have already signed the informed consents.
We thank you for your good cooperation.
Yours sincerely,
Marlies Groenendijk (trialmanager)
1. Overview
Summary
A Randomized Phase III study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.
Status
closed
Members
Participating groups: ALFA, CETLAM, EBMT (ALWP), GOELAMS, HOVON, OSHO, SAKK

Study details
Type of study
Prospective randomized Phase III study
Echelon level
Level B
Echelon level specification
Samenwerkingsafspraak moet gemaakt worden met Level A ziekenhuis voor allogene stamceltransplantatie
Type of monitoring for this study
Site evaluation visits
Target number of patients
367
Current number of patients
0
Approved by
EudraCTnr.: 2007-003514-34
CKTO: 2008-4332 (07APR09)
CCMO: NL24236.000.08 (20JUL09)
Study objectives
Primary:
To evaluate leukaemia free survival (LFS) for older patients after allogeneic SCT in AML/RAEB in CR using matched or unrelated donors in comparison to conventional chemotherapy.
Secondary:
Overall Survival
Cumulative incidence of relapse
TRM and complications
Incidence of myelosuppression (ANC < 500/mm³ for > 2 days, platelets < 20,000/mm³ for > 2 days) after initial PBSC infusion
Incidence of grades 2-4 acute GvHD after transplant
Incidence of grades chronic extensive GvHD after DLI
2. Patient eligibility criteria
Inclusion criteria
At registration:
Age ≥ 60years and ≤ 75 years
AML as defined by WHO
Refractory anaemia with excess of blasts (RAEB)
primary and secondary AML
First complete remission following one or two cycles of induction chemotherapy, administered according to current participating cooperative group protocols
Karnofsky score > 70% (see appendix D)
Written informed consent
At randomisation:
All registered patients who meet the inclusion criteria and do not meet any of the
exclusion criteria after the first consolidation cycle are randomised if they have a
10/10 matched donor:
Patient is registered in this trial
Complete remission must be confirmed after first consolidation cycle according to the response criteria enlisted in appendix B with the following exception regarding the peripheral blood recovery (B1):
o Peripheral Blood Recovery (PBR): ANC ³1.0 x 109/l or 1500/mm³, transfusion independent platelet count ³ 50 x 109/l (i.e. 48 h after last transfusion) and no leukemic blasts in the peripheral blood and no dysplasia
o AND platelet count must be increasing
Matching (10/10: HLA-A, -B, -C, DRB1 and DQ) related or unrelated donor is available
Exclusion criteria
At registration:
AML FAB M3
HIV positivity
Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if
o The second study exclusively concerns induction therapy
o Consolidation cycle one and two are given according to the accredited study group policy
o No investigational drugs are used post registration for the HCT vs CT in eldery AML study.
o Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted
At randomisation:
Patient has undergone more than one consolidation cycle
More than 5 months (>150 days) after diagnosis
Organ dysfunction
o Patients with creatinine clearance < 50 ml/min
o Cardiac ejection fraction < 40%
o Severe defects in pulmonary function testing (defects are currently categorized as mild, moderate and severe) as defined by the pulmonary
consultant, or receiving supplementary continuous oxygen
o Liver function tests: total bilirubin > 2x the upper limit of normal, SGOT and SGPT 4x the upper limit of normal
Patients with poorly controlled hypertension
Participation in another clinical trial without prior consent of the coordinating investigator
3. Registration (& randomization) of patients
Registration
All patients with AML, in CR1, in the participating centre should be registered prospectively to the EBMT Clinical Trials Office (CTO). Centres should complete the registration form and email or fax it to the EBMT CTO as per the contact details on the form. The EBMT will send confirmation of the registration and notify the centre of the patient's assigned study number.
4. Participating parties
Principal Investigator(s)
Prof. Dr. J.J. Cornelissen (Erasmus MC - Daniel)
Co-Investigator(s)
Prof. Dr. B. Löwenberg (Erasmus MC)
Coordinating Investigator(s)
Dr. D. Niederwieser (University of Leipzig)
Statistician(s)
Dhr. Dr. B. van der Holt (Erasmus MC - Daniel)
Monitor - Site Evaluation Visits
Mw. T. van de Klundert (Erasmus MC - Daniel)
Trial manager
M.E. Groenendijk-Sijnke (m.groenendijk-sijnke@erasmusmc.nl)
Central data management
EBMT
Other functions
Please contact monitors at hdcmonitorteam@erasmusmc.nl
5. Participating sites
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.