The hypothesis to be tested is that arm A and/or arm B are feasible.
ID
Bron
Verkorte titel
Aandoening
Acute lymphoblastic leukemia in relapse
Ondersteuning
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
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The hypothesis to be tested is that arm A and/or arm B are feasible.
Onderzoeksproduct en/of interventie
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.
Publiek
P.O. Box 9600
R. Willemze
Leiden 2300 RC
The Netherlands
+31 (0)71 5262267
rwillemze@lumc.nl
Wetenschappelijk
P.O. Box 9600
R. Willemze
Leiden 2300 RC
The Netherlands
+31 (0)71 5262267
rwillemze@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL614 |
| NTR-old | NTR673 |
| Ander register | : HO74 |
| ISRCTN | ISRCTN86445183 |