Alemtuzumab as remission induction for adult patients with acute lymphoblastic leukemia in relapse; A randomized phase II study.

• Conditions: Acute lymphoblastic leukemia in relapse

• Registration Number: NL-OMON28605
• Lead Sponsor: Stichting Hemato-Oncologie Volwassenen Nederland (HOVON)P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1. Age 18 - 70 years inclusive;
2. First or second relapse of precursor B-ALL or T-ALL (including Philadelphia chromosome or BCR-ABL positive ALL);
3. Duration of last complete remission at least 6 months;
4. WHO performance status 0, 1, or 2;
5. Negative pregnancy test at inclusion if applicable;
6. Written informed consent.

Exclusion Criteria

1. Mature B-cell ALL, i.e. Burkitt leukemia/lymphoma;
2. Acute undifferentiated leukemia (AUL);
3. Treatment with alemtuzumab at any time prior to registration;
4. Intolerance of exogenous protein administration;
5. Central nervous system (CNS) leukemia (appendix A);
6. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
7. Severe pulmonary dysfunction (CTCAE grade III-IV);
8. Severe neurological or psychiatric disease;
9. Significant hepatic dysfunction (serum bilirubin or transaminases >= 3 times normal level);
10. Significant renal dysfunction (serum creatinine >= 3 times normal level);
11. Patients with active, uncontrolled infections;
12. Patients with uncontrolled asthma or allergy, requiring oral steroid treatment at the time of registration;
13. Patients known to be HIV-positive;
14. Patient is a lactating woman;
15. Any psychological, familial, sociological or 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
1. Percentage of patients that reach a CR on induction cycle I in each arm;<br>2. Percentage of patients with severe toxicity on induction cycle I in each arm.

Secondary Outcome Measures

Name	Time	Method
1. Toxicity profile related to each treatment step and intervals between treatment steps;<br>2. 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>3. Disease-free survival (i.e. time from achievement of CR to date of relapse or death from any cause, whichever occurs first);<br>4. Overall survival measured from time of registration.