HOVON HO18 ALL

Gearchiveerd

Main info

Identificatie:
HO18 ALL
Sponsor:
HOVON
Age:
Any age
Stadium:
1st lijn
Included patients:
210
Active sites:
0
(of 17)
17 sites are pending
Title:

Autologous Bone Marrow Transplantation with a Radiation-free Preparatory Regimen (Bu/Cy) in adult patients with ALL in the first remission after Conventional Induction and Intensification Chemotherapy: A Phase II Study.

Timeline

Scheduled
Actual
1993
15 jun.
Activated
1993
15 jun.
Activated
1999
05 apr.
Closeout in Progress
1999
05 apr.
Closeout in Progress
2009
05 apr.
Archived
2009
05 apr.
Archived
2025
15 jun.
Destruction
2025
15 jun.
Destruction

Flow

Flow

Details

Phase:
Prospective Phase II study
Monitoring Type:
Objectives:

Eligibility

Inclusion Criteria:
  • Age between 16 and 60 years.
  • Previously untreated.
  • All according to the FAB criteria.
  • AUL according to immunological marker analysis.
  • Patients must have persistant serum creatinine < 200 �mol/l.
  • Patients must have serum direct bilirubin < 65 �mol/l.
  • WHO performance status grade 0, 1, 2 or 3.
  • Absence of other severe disease.
Exclusion Criteria:
  • Performance status grade 4 according to the WHO classification.
  • Severe cardiac, pulmonary, hepatic, renal, neurologic, psychiatric or metabolic disease.
  • Second primary malignant disease, except cervix carcinoma and non-melanoma skin cancer.
  • Persisting renal insufficiency.
  • Patients previously treated with chemotherapy.
  • Active uncontrolled infections.
  • HIV positivity on serological tests.

Registration Details

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
  • Institutions name
  • Patients namecode
  • Date of birth
  • Hospital record number
  • Name of responsible investigator
  • Date of start treatment

Participating Sites

Site
17 results
Order by
Accrual rate
Activation date
NL-Amsterdam-VUMC
35
NL-Utrecht-UMCUTRECHT
28
NL-Rotterdam-ERASMUSMC
25
BE-Leuven-UZLEUVEN
22
NL-Rotterdam-EMCDANIEL
21
NL-Maastricht-MUMC
20
NL-Amsterdam-AMC
11
NL-Den Haag-HAGA
11
NL-Enschede-MST
7
NL-Sittard-Geleen-ZUYDERLAND
7
NL-Zwolle-ISALA
6
NL-Amersfoort-MEANDERMC
4
NL-Heerlen-ATRIUMMC
4
NL-Nieuwegein-ANTONIUS
3
NL-Amsterdam-SLOTERVAART
1
NL-Leeuwarden-MCL
1
NL-Utrecht-DIAKONESSENUTRECHT
1
= Active hospitals
= Inactive hospitals

Participating Parties

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