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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 30 AML


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


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1. Overview



Summary

Addition of Cyclosporin A to the Combination of Mitoxantrone and Etoposide to Overcome Resistance to Chemotherapy in Refractory Acute Myeloid Leukemia: A Randomized Phase II Study.


Status

closed



Study details



Type of study

Prospective randomized Phase III study


Target number of patients

50


Date of activation

15-Jan-1995


2. Patient eligibility criteria



Inclusion criteria

Newly diagnosed adult AML patients in sufficiently good condition who did not attain CR after standardized chemotherapy courses with idarubicin plus Ara-C and AMSA plus Ara-C respectively (HOVON 29).
Adult patients with AML in first or subsequent relapse after a previously attained CR.


Exclusion criteria

AML patients not fulfilling the above inclusion criteria.
Patients with myelodysplasia.
Severe cardiac, pulmonary, neurologic or metabolic disease.
Suboptimal kidney function.
Uncontrolled hypertension.
Liver function abnormalities.
Severe infection not controllable with adequate antimicrobial therapy.
Serological positivity for HIV.
Concomitant malignancy except non-melanomatous skin tumors and carcinoma in situ of the cervix uteri.
Pregnancy.
Known intolerance for one of the study drugs.
Refusal of the patient.


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:



Name of treatment center and name of responsilble physician
Name or initials of the patient
Hospital record number
Date of birth / sex
Date of diagnosis of AML
Registered in a former HOVON AML induction study? if so, registration number in that study
Best response to previous chemotherapy


4. Participating parties



Principal investigator

S Daenen (m.g.daenen@int.azg.nl)


Coordinating investigator(s)

P Sonneveld (sonneveld@haed.azr.nl


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)
B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

MMC Steijaert (steijaert@stah.azr.nl)


Central data management

MMC Steijaert (steijaert@stah.azr.nl)


Other functions

Please contact monitors at hdcmonitorteam@erasmusmc.nl


5. Participating sites



Site
Included patients *
BE-Bruxelles-Cliniques Universitaires St. Luc
2
BE-Leuven-UZ Gasthuisberg
14
CH-Basel-University Hospital Basel
3
CH-Bern-Inselspital
0
CH-St. Gallen-Kantonsspital St. Gallen
0
CH-Zürich-Universitätsspital
0
NL-Amersfoort-Meander MC
3
NL-Amersfoort-Meander MC
3
NL-Amsterdam-AMC
0
NL-Amsterdam-VUMC
5
Show 9 more...
* 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




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