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 29 AML / SAKK 30/95
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
No news
1. Overview
Summary
Remission Induction Chemotherapy with or without rHuG-CSF (lenograstim) sensitization.
Marrow Ablative Chemotherapy plus Autologous Peripheral Progenitor/Stem Cell Transplantation (PBSCT) versus Chemotherapy.
Status
closed

Study details
Type of study
Prospective randomized Phase III study
Target number of patients
600
Date of activation
15-Mar-1995
Date closed
01-Dec-1998
Approved by
CKVO No. 94-14
2. Patient eligibility criteria
Inclusion criteria
Patients with newly diagnosed de novo AML.
Age 15-60 years inclusive.
Patients have given infomed consent.
Leucocytosis is not an exclusion criterium, but it will require postponement of G-CSF administration until WBC have declined to 20 x 109/l on chemotherapy.
Exclusion criteria
A concurrent active malignancy, except stage I cervix carcinoma and basocellular carcinoma.
Previous treatment with chemotherapy.
Leukemia following from a documented myelodysplasia with a duration of more than 6 months.
Blastic crisis of chronic myeloid leukemia or leukemia developing from myeloproliferative diseases.
Renal or liver function abnormalities.
HIV positive serology.
Severe cardiac, pulmonary or neurologic disease.
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 number/name
Patient�s initials or code
Patient�s hospital record number
Name of caller/responsible investigator
Sex
Date of birth
Date of diagnosis of AML
WHO performance status
White blood cell count (WBC)
FAB and cytogenetics (if available)
4. Participating parties
Principal investigator
B L�wenberg (lowenberg@hema.fgg.eur.nl)
Coordinating investigator(s)
MA Boogaerts
J Gm�r (j.gmuer@freesurf.ch)
Statistician(s)
W.L.J. van Putten (w.vanputten@erasmusmc.nl)
Trial manager
M.C.J. Testroote (m.testroote@erasmusmc.nl)
Central data management
M.C.J. Testroote (m.testroote@erasmusmc.nl)
Other functions
Please contact monitors at hdcmonitorteam@erasmusmc.nl