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


- candidate number2079
- NTR NumberNTR673
- ISRCTNISRCTN86445183
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR4-mei-2006
- Secondary IDsHO74 
- Public TitleAlemtuzumab as remission induction for adult patients with acute lymphoblastic leukemia in relapse; A randomized phase II study.
- Scientific TitleAlemtuzumab as remission induction for adult patients with acute lymphoblastic leukemia in relapse; A randomized phase II study.
- ACRONYMHOVON 74 ALL
- hypothesisThe hypothesis to be tested is that arm A and/or arm B are feasible.
- Healt Condition(s) or Problem(s) studiedAcute Lymfatic Leukemia (ALL)
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 15-mei-2006
- planned closingdate15-apr-2008
- Target number of participants120
- InterventionsRelapsed 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.
- Primary outcome1. 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 outcome1. 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.
- Timepoints
- Trial web sitehttp://www.hovon.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. R. Willemze
- CONTACT for SCIENTIFIC QUERIESProf. Dr. R. Willemze
- Sponsor/Initiator HOVON Data Center
- Funding
(Source(s) of Monetary or Material Support)
Amgen, Dutch Cancer Society, Roche Nederland BV, Novartis Pharma B.V., Johnson&Johnson-Orthobiotech, Schering International
- PublicationsN/A
- Brief summaryStudy 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.
- Main changes (audit trail)
- RECORD4-mei-2006 - 3-jul-2006


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