A Phase II, Multi-center, Open-label, Repeat-dose Study of Lenalidomide (Revlimid ®) Plus Low-dose Dexamethasone in Patients With Refractory B Cell Lineage Acute Lymphoblastic Leukemia or in Relapse After 2 Lines of Treatment
The study consists of two periods, an initial treatment period and an extended treatment
period. Patients who meet all eligibility criteria will receive: Lenalidomide 25 mg p.o.
once daily on days 1-21 plus Dexamethasone 40 mg p.o. once daily on days 1, 8, 15, and 22 of
each 28-day cycle (4-weeks cycles) until CR achievement, progression of disease or
intolerable toxicity. The daily dose of Lenalidomide and that of Dexamethasone will remain
fixed. No dose adaptations are allowed according to the hematologic toxicity. However, in
case of non-hematologic grade > 2 toxicity, the next cycle may be delayed up to 21 days
after the onset of the event until the adverse event has returned to baseline or ≤ grade 1.
Patients may be allowed to receive a pre-treatment with high doses of dexamethasone for
initial hyperleukocytosis at the discretion of the investigator. The use of hematopoietic
growth factor (HGF) during the initial or extended treatment period is also let at the
discretion of the investigator. At the end of the initial treatment period, all responding
patients (without HLA compatible donor) or patients showing sufficient clinical activity
will be allowed to receive extended treatment with cycles identical to the first cycle.
Patients may continue to receive treatment as long as the patient is tolerating the
treatment well and the patient's physician believes the patient is receiving some benefit.
The severity of adverse events will be graded according to the World Health Organization
(WHO) criteria. Any life-threatening adverse effects that are observed during the initial or
extended treatment period, which are possibly or probably related to study drug, will
require the subject to discontinue study treatment.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-Free survival (DFS)
2 years
No
Emmanuelle Tavernier, MD
Principal Investigator
Institut de Cancérologie de la Loire
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
2009-01b
NCT01116193
January 2010
July 2013
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