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Report for Clinical Trial NCT01116193
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
The study objectives are to evaluate the safety and efficacy of the oral administration of
lenalidomide in combination with dexamethasone in the treatment of adult patients with
refractory or relapsed non-Ph+ B-cell lineage acute lymphoblastic leukemia (ALL).
Name: Lenalidomide plus dexamethasone
Description: 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
Type: Drug
Primary Outcomes
Measure: Disease-Free survival (DFS) Time: 2 years
Secondary Outcomes
Measure: Time to response Time: 28 days
Measure: Duration of response Time: 2 years
Measure: To determine quality of life (QOL): European Organization for Research and Treatment of Cancer QOL questionnaire for patients with cancer (EORTC QLQ-C30) Time: All 28 days
Measure: Progression-free survival Time: 2 years
Measure: Feasibility of stem cell transplantation (SCT), in case of response, after one or more cycles of lenalidomide plus dexamethasone therapy Time: all 28 days
Measure: Safety of lenalidomide plus dexamethasone: adverse events (type, frequency, severity of adverse events, and relationship of adverse events to study drug). Time: All 28 days
Measure: To assess the efficacy of lenalidomide plus low-dose dexamethasone: complete response (CR), complete response without platelets (CRp), partial response (PR), and overall response (CR + CRp + PR). Time: 1, 8, 15, and 22 of each 28-day cycle (4-weeks cycles) and after treatment, patients will be seen at least twice weekly until they attain a CR
Measure: Overall survival Time: 2 years
Purpose: Treatment
Allocation: Non-Randomized
Single Group Assignment
There is one SNP
SNPs
1 T315I
The inclusion of a patient with Ph+ ALL can be possible
after contacting the principal investigator in presence of a T315I mutation and
absence of investigational trial targeting this abnormality. --- T315I ---