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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


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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 - Centrum)


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


5. Participating sites



Site
Included patients *
NL-Amsterdam-AMC
0
NL-Amsterdam-VUMC
0
NL-Maastricht-AZ Maastricht
0
NL-Rotterdam-Erasmus MC - Daniel
0
NL-Rotterdam-Erasmus MC - Centrum
0
NL-Zwolle-Isala
0

* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol



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