Main info

Identifier:

HO37 ALL

Sponsor:

HOVON

Included patients:

249

Active sites:

14

(of 14)

Title:

Early Intensification by (un)related Allogenic or Autologous Stem Cell Transplantation in Adult Acute Lymphoblastic Leukemia: A Phase II Study.

Timeline

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Age between 16 and 59 (inclusive) years.
• Previously untreated with chemotherapy.
• ALL according to the FAB criteria and immunological marker analysis (B-precursor ALL, T-ALL and AUL)
• WHO performance status grade 0, 1, 2 or 3.
• Patient informed consent.

Patients will be randomised for maintenance chemotherapy one week prior to the start of the conditioning regimen of autologous SCT, after informed consent has been obtained for either no therapy or maintenance therapy for one year.

Criteria for Start of Maintenance Therapy

• CR after autologous SCT.
• Hematological recovery.

a. leukocytes > 3 x 109/l.
b. platelets > 80 x 109/l.

• WHO performance status 0, 1, 2.

Exclusion Criteria:

• B-ALL
• Severe cardiac, pulmonary, hepatic, renal, neurologic, psychiatric or metabolic disease.
• Second malignant disease, except cervix carcinoma stage 1 and non-melanoma skin cancer.
• Persisting renal insufficiency.
• Active uncontrolled infections.
• HIV positivity.

Exclusion Criteria for Start of Maintenance Therapy

• Severe toxicity CTC grade > 1.
• No BM-recovery after 3 months.
• Previous allergic lung reaction to MTX.

Participating Sites

= Active hospitals

= Inactive hospitals