Main info

Identifier:

HOVON 71 ALL

Sponsor:

HOVON

Included patients:

60

Active sites:

21

(of 21)

Title:

Treatment of acute lymphoblastic leukemia (ALL) in adults age 40 - 70 years inclusive with chemotherapy including a pre-induction course for rapid tumor load reduction and prolonged maintenance chemotherapy.

Timeline

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Age 40 - 70 years inclusive;
• Primary previously untreated 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 (AUL);
• Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
• Severe pulmonary dysfunction (CTCAE grade III-IV);
• Severe neurological or psychiatric disease;
• Significant hepatic dysfunction (serum bilirubin or transaminases >=3 times normal level) except when caused by leukemic infiltration;
• Significant renal dysfunction (serum creatinin >=3 times normal level after rehydration and correction of hyperuricemia);
• History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
• History of anthracycline use exceeding a cumulative dose of 300 mg/m2 doxorubicin (or its biological equivalent);
• 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