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

Not Applicable

Completed

Conditions: Acute Lymphoblastic Leukemia
Cancer
Lymphoid leukaemia

Registration Number: ISRCTN00446029

Lead Sponsor: Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 55

Inclusion Criteria

1. Age 40 - 70 years inclusive
2. Primary previously untreated ALL*
3. WHO performance status 0, 1, or 2
4. Negative pregnancy test at inclusion if applicable
5. Written informed consent

*Patients with mediastinal mass defining the so-called T-lymphoblastic leukemia/lymphoma are eligible for this trial. ALL patients with Philadelphia chromosome - t(9;22) and variants - are also eligible for this trial. However, when an alternative trial for Philadelphia chromosome positive patients becomes available, patients should be included in that trial by preference.

Exclusion Criteria

1. Mature B-cell ALL, i.e. Burkitt leukemia/lymphoma
2. Acute undifferentiated leukemia (AUL)
3. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
4. Severe pulmonary dysfunction (Common Terminology Criteria for Adverse Events [CTCAE] grade III-IV)
5. Severe neurological or psychiatric disease
6. Significant hepatic dysfunction (serum bilirubin or transaminases = 3 times normal level) except when caused by leukemic infiltration
7. Significant renal dysfunction (serum creatinine = 3 times normal level after rehydration and correction of hyperuricemia)
8. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
9. History of anthracycline use exceeding a cumulative dose of 300 mg/m2 doxorubicin (or its biological equivalent)
10. Active, uncontrolled infections
11. Patient known to be HIV-positive

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival (i.e. time from achievement of complete response [CR] to day of relapse or death from any cause, whichever comes first)

Secondary Outcome Measures

Name	Time	Method
1. CR rate after remission induction and consolidation<br>2. Toxicity profile related to each treatment step and intervals between treatment steps<br>3. Event-free survival (i.e. time from registration until no CR on protocol, relapse or death, whichever comes first); Event-free survival for patients without a CR is set at one day<br>4. Overall survival measured from time of registration<br>5. Outcome of patients with a reduced intensity conditioning allogeneic stem cell transplantation