Main info

Identifier:

HO18 ALL

Sponsor:

HOVON

Age:

Any age

Stage:

1st Line

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

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

Participating Sites

= Active hospitals

= Inactive hospitals