Main info

Identificatie:

HOVON 70 ALL

Sponsor:

HOVON

Included patients:

54

Active sites:

18

(of 20)

Title:

Feasibility study using repeated intensive chemotherapy courses for patients with primary acute lymphoblastic leukemia in adults age 18 - 39 years inclusive.

Timeline

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Age 18 - 39 years inclusive;
• Primary previously untreated ALL (including Philadelphia chromosome or BCR-ABL positive ALL);
• WHO performance status 0, 1, or 2 (appendix C);
• Negative pregnancy test at inclusion if applicable;
• Written informed consent.

Exclusion Criteria:

• Mature B-cell ALL;
• Acute undifferentiated leukemia;
• Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
• Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
• Severe neurological or psychiatric disease;
• Significant hepatic dysfunction (serum bilirubin or transaminases >=3 times normal level);
• Significant renal dysfunction (serum creatinine >= 3 times normal level);
• History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
• Active, uncontrolled infections;
• Patients known to be HIV-positive;
• Patient is a lactating woman;
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Participating Sites

= Active hospitals

= Inactive hospitals