sluit venster

Log in

Gebruikersnaam Wachtwoord Gebruikersnaam en/of wachtwoord vergeten? Gebruikersnaam en wachtwoord aanvragen

Zoek in de HOVON website

Let op!
Mogelijk ziet u niet alle beschikbare info op deze pagina, omdat u niet bent ingelogd, of omdat u niet de juiste privileges heeft.

Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 53 AML / OSHO


News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


return to top

News


No news


1. Overview



Summary

Allografting as Consolidative Immunotherapy for Older Patients with AML in Complete Remission Using Low Dose TBI, PBSC Infusion And Post-Transplant Immunosuppression With Cyclosporine And Mycophenolate Mofetil


Status

closed


Type of study

Prospective Phase II study


Target number of patients

40


Approved by

MEC: METC UMCU 01/190-E, 22 October 2001


2. Patient eligibility criteria



Inclusion criteria

Age 50-75 years, inclusive;
AML as defined by the HOVON/SAKK AML-43 protocol (M0-M2 and M4-M7, FAB classification);
Refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >1,5 (Appendix A);
AML in first or later CR;
Have a HLA identical family donor or a HLA identical unrelated donor;
Karnofsky score > 70 (see appendix B);
Written informed consent.


Exclusion criteria

AML FAB M3;
Patients with a creatinine clearance < 50 ml/min;
Cardiac ejection fraction < 40%;
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;
Liver function tests: total bilirubin > 2x the upper limit of normal, SGOT and SGPT 4x the upper limit of normal;
Karnofsky score <=60 (see appendix E );
Patients with poorly controlled hypertension;
HIV positivity;


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Patient?s initials or code
Patient?s hospital record number
Sex
Date of birth
Date of diagnosis of AML
Eligibility criteria

All patients with an HLA-identical donor should be registered with the enclosed form. Patients undergoing stem cell transplant should be notified prospectively to the HOVON and OSHO data center. See chapter 16Fill out the patient registration form to check eligibility before registring.


4. Participating parties



Principal investigator

Leo F. Verdonck


Coordinating investigator(s)

GJ Ossenkoppele
M Boogaerts
Urs Schanz
Christoph Huber
Catherine Cordonnier
Hildegard Greinix


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)


Central data management

Rainer Krahl


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



return to top