Main info

Identifier:

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

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

= Active hospitals

= Inactive hospitals