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
1999
05 apr.
Closeout in Progress
2009
05 apr.
Archived
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

Up