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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

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 ---



HPO Nodes


HPO:
Leukemia
Genes 190
ATM KRAS KIT RPS15A NF1 MPL RPL35A RPL11 RPL18 DDX41 SBDS LPP ETV6 BUB1B F13A1 DNMT3A JAK2 NUP214 FANCD2 MSH6 FANCA PIGL NRAS TCIRG1 BUB1 TET2 FLT3 TAL1 ATRX TREX1 PDGFRA SRP54 RPS29 PTPN11 CALR FANCE WIPF1 SF3B1 GATA2 GLI1 STS SH3GL1 XRCC4 MPL SH2B3 EFL1 PIGA TREM2 CBL MPL RUNX1 MPL PIGL THPO FANCG NSD1 BRD4 NSUN2 SH2B3 RARA GATA2 NPM1 CBL CHIC2 ERBB3 GFI1 TERT KIT BCR ARHGAP26 DYNC2LI1 EVC SCN10A GATA1 ELANE RNASEH2B RPS14 SH2B3 JAK2 RPL15 SBDS NRAS RPL26 RPL27 ADA2 RPS7 TYROBP F13B MSH2 BCR WAS TERC TP53 TRIP13 MYD88 NUTM1 RPS24 GNB1 TP53 DNMT3A TERT NUMA1 NUP214 RPL5 SAMD9L TET2 CFTR POT1 FANCC RPS10 EP300 EVC2 BUB1B CEBPA BRCA2 DNAJC21 CALR SCN9A LIG4 ADAR BLM TET2 JAK2 SMPD1 RNASEH2C SCN11A GATA2 BUB3 PRSS1 KIF11 BCR RPL35 TAL2 SRP54 IFIH1 ABL1 PDGFRB KRAS RNASEH2A TET2 MLLT10 SRP54 DNAJC21 DKC1 RUNX1 APC LIG4 CBFB BLM THPO CALR NBN JAK2 MLH1 RPS19 ELANE SAMD9L RPL31 PMS2 ASXL1 TSR2 MLF1 PIK3CA DNAJC21 RUNX1 GFI1 SRSF2 SETBP1 HAX1 RPS26 RPS17 FLT3 RPS27 PIK3R1 KRAS CEP57 PICALM CREBBP GATA2 CTRC MYD88 TET2 RPS28 ABL1 RB1 SPINK1 GATA1 NBN JAK2 SAMHD1
Lymphoid leukemia