No registrations found.
ID
Source
Brief title
Health condition
Acute lymphoblastic leukemia in relapse
Sponsors and support
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Intervention
Outcome measures
Primary outcome
1. Percentage of patients that reach a CR on induction cycle I in each arm;
2. Percentage of patients with severe toxicity on induction cycle I in each arm.
Secondary outcome
1. Toxicity profile related to each treatment step and intervals between treatment steps;
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;
3. Disease-free survival (i.e. time from achievement of CR to date of relapse or death from any cause, whichever occurs first);
4. Overall survival measured from time of registration.
Background summary
Study phase: Randomized phase II
Study objective: Evaluation of feasibility of alemtuzumab in adult patients with relapsed ALL after a 1st or 2nd CR
Patient population: Patients, age 18 – 70 years inclusive, with relapsed ALL, non-mature B-cell
Study design: Prospective, multicenter, randomized
Duration of treatment: Expected duration of treatment will be approximately 11 weeks.
Study objective
The hypothesis to be tested is that arm A and/or arm B are feasible.
Intervention
Relapsed ALL patients under the age of 71 years will be registered and randomized to receive:
Arm A: prednisone and methotrexate in the pre-phase and thereafter two remission induction courses of alemtuzumab 30 mg.
Or
Arm B: prednisone and methotrexate in the pre-phase and thereafter two remission induction courses of alemtuzumab 60 mg.
P.O. Box 9600
R. Willemze
Leiden 2300 RC
The Netherlands
+31 (0)71 5262267
rwillemze@lumc.nl
P.O. Box 9600
R. Willemze
Leiden 2300 RC
The Netherlands
+31 (0)71 5262267
rwillemze@lumc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL614 |
| NTR-old | NTR673 |
| Other | : HO74 |
| ISRCTN | ISRCTN86445183 |