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Report for Clinical Trial NCT01116193

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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 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).

NCT01116193 Leukemia, Lymphoid Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
MeSH:Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
HPO:Leukemia Lymphoid leukemia

1 Interventions

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


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 ---

HPO Nodes