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

Completed

Conditions: Acute Lymphoblastic Leukemia (ALL)
Cancer
Lymphoid leukaemia

Registration Number: ISRCTN78775328

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: 50

Inclusion Criteria

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

Exclusion Criteria

1. Mature B-cell ALL
2. Acute undifferentiated leukemia
3. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
4. Severe pulmonary dysfunction (CTCAE grade III-IV)
5. Severe neurological or psychiatric disease
6. Significant hepatic dysfunction (serum bilirubin or transaminases = 3 times normal level)
7. Significant renal dysfunction (serum creatinine = 3 times normal level)
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. Active, uncontrolled infections
10. Patient known to be HIV-positive
11. Patient is a lactating woman
12. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients that reach a complete response (CR), complete all intensive phases of the protocol, and start with maintenance therapy within 11 months after start pre-phase or receive an allogeneic stem cell transplantation within 7.5 months after start pre-phase.

Secondary Outcome Measures

Name	Time	Method
1. CR rate after remission induction, consolidation, intensification, and maintenance<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. Disease-free survival (i.e. time from achievement of CR to day of relapse or death from any cause, whichever occurs first)<br>5. Overall survival measured from time of registration