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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78775328

Enrollment

Registered

2010-09-06

Start date

2005-10-21

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia (ALL) Cancer Lymphoid leukaemia

Interventions

Patients will be treated with the following courses: 1. Pre-phase course consisting of 60 mg/m2/day for 7 days. Induction consisting of prednisone, vincristine, daunorubicin, cyclophosphamide and L-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. CR rate after remission induction, consolidation, intensification, and maintenance 2. Toxicity profile related to each treatment step and intervals between treatment steps 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 4. Disease-free survival (i.e. time from achievement of CR to day of relapse or death from any cause, whichever occurs first) 5. Overall survival measured from time of registration	—

Measure

Time frame

1. CR rate after remission induction, consolidation, intensification, and maintenance 2. Toxicity profile related to each treatment step and intervals between treatment steps 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 4. Disease-free survival (i.e. time from achievement of CR to day of relapse or death from any cause, whichever occurs first) 5. Overall survival measured from time of registration

—

Countries

Belgium, Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026