HOVON HO32 MDS

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Main info

Identificatie:
HO32 MDS / ELDERLY AML
Sponsor:
HOVON
Included patients:
137
Active sites:
0
(of 16)
16 sites are pending
Title:

Randomised Phase II Study on the Value of Fludarabine in addition to ARA-C and G-CSF in the Treatment of Patients with Myelodysplastic Syndromes and Elderly Acute Myeloid Leukemia.

Timeline

Scheduled
Actual
1996
14 okt.
Activated
2006
14 okt.
Archived

Flow

Flow

Details

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

Eligibility

Inclusion Criteria:
  • Patients with ages between 15 and 75 years with a primary or secondary hematological diagnosis of myelodysplasia.
  • Patients with ages between 61 and 75 years with a primary or secondary diagnosis of AML.
  • Performance status 0, 1 or 2 according to the WHO performance scale
  • Serum creatinin < 120 �mol/l
  • Serum bilirubin < 25 �mol/l. ALAT and ASAT and AP less than 2.5 times the upper limit of normal.
  • Informed consent.
Exclusion Criteria:
  • Severe cardiac, pulmonary, neurologic, metabolic or psychiatric disease.
  • Malignancy, except stage I cervix carcinoma and basal carcinoma of the skin.
  • Active uncontrolled infections.
  • Chemotherapy within 6 months before entry to the study.
  • Pregnancy.
  • Blastic crisis of CML, or leukemia developing from Mypro.

Participating Sites

Site
16 results
Order by
Accrual rate
Activation date
BE-Leuven-UZLEUVEN
28
NL-Amsterdam-VUMC
23
NL-Rotterdam-EMCDANIEL
18
NL-Rotterdam-ERASMUSMC
14
BE-Brugge-AZBRUGGE
12
NL-Nieuwegein-ANTONIUS
10
NL-Utrecht-UMCUTRECHT
8
NL-Groningen-UMCG
4
NL-Nijmegen-RADBOUDUMC
4
NL-Enschede-MST
4
BE-Roeselare-AZDELTA
3
NL-Amersfoort-MEANDERMC
2
NL-Zwolle-ISALA
2
NL-Amsterdam-AMC
2
NL-Amsterdam-SLOTERVAART
2
NL-Zutphen-GELREZUTPHEN
1
= Active hospitals
= Inactive hospitals

Participating Parties

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