HOVON HO29 AML

Gearchiveerd

Main info

Identificatie:
HO29 AML / SAKK 30/95
Sponsor:
HOVON
Included patients:
1105
Active sites:
0
(of 35)
35 sites are pending
Title:

Remission Induction Chemotherapy with or without rHuG-CSF (lenograstim) sensitization.
Marrow Ablative Chemotherapy plus Autologous Peripheral Progenitor/Stem Cell Transplantation (PBSCT) versus Chemotherapy.

Timeline

Scheduled
Actual
1995
15 mrt.
Activated
1998
01 dec.
ClosedForInclusionActualStart
2008
01 dec.
Archived

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
Monitoring Type:
Objectives:

Eligibility

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.

Participating Sites

Site
35 results
Order by
Accrual rate
Activation date
NL-Amsterdam-VUMC
94
BE-Leuven-UZLEUVEN
86
NL-Groningen-UMCG
85
CH-Zürich-USZ
73
NL-Utrecht-UMCUTRECHT
67
NL-Rotterdam-ERASMUSMC
65
NL-Rotterdam-EMCDANIEL
63
CH-Bern-INSEL
42
NL-Maastricht-MUMC
41
BE-Bruxelles-STLUC
39
CH-Basel-USB
32
NL-Amsterdam-AMC
30
CH-Lausanne-CHUV
30
NL-Den Haag-HAGA
29
NL-Enschede-MST
26
BE-Yvoir-MONTGODINNE
25
CH-St. Gallen-KSSG
24
CH-Aarau-KSA
23
NL-Zwolle-ISALA
22
CH-Geneve (14)-HCUGE
20
NL-Amersfoort-MEANDERMC
19
NL-Nieuwegein-ANTONIUS
13
NL-Amsterdam-AVL
12
CH-Neuchatel-HNE
10
BE-Haine-Saint-Paul-JOLIMONT
10
CH-Bellinzona-SANGIOVANNI
9
CH-Winterthur-KSW
7
DE-Frankfurt am Main-NORDWEST
4
NL-Meppel-ISALADIACONESSEN
4
NL-Delft-RDGG
2
NL-Leeuwarden-MCL
1
NL-Eindhoven-CATHARINA
1
NL-Amsterdam-SLOTERVAART
1
NL-Hilversum-TERGOOI
1
DE-Mainz-UNIMEDIZINMAINZ
= Active hospitals
= Inactive hospitals

Participating Parties

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