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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


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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


5. Participating sites



6. Instruction videos



7. Download documentation / forms




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