SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01116193

Developed by Shray Alag, 2019.
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 125
MPL RNASEH2B KRAS NPM1 TET2 MYD88 TSR2 RPL26 RPL27 TREX1 EFL1 PIGL SCN11A FLT3 PMS2 RPL35A EVC2 ABL1 CEBPA RARA NRAS WAS WIPF1 ATRX SH2B3 PDGFRA RB1 RNASEH2A PDGFRB CALR ARHGAP26 SH3GL1 RPS7 RPS10 NUMA1 GATA1 GATA2 RPS15A APC NSD1 ETV6 TCIRG1 DNAJC21 EVC SRP54 RPS17 NBN RPS19 SAMHD1 MSH2 RPS24 NUP214 RPS26 RPS27 RPS28 RPS29 MLLT10 RUNX1 XRCC4 CBFB CBL BCR ADAR TRIP13 ADA2 NSUN2 CREBBP PICALM GFI1 F13A1 F13B FANCA FANCC BLM FANCD2 FANCE NUTM1 JAK2 IFIH1 TYROBP MSH6 FANCG LIG4 PTPN11 SAMD9L THPO NF1 STS PIGA BRCA2 DYNC2LI1 PIK3CA SBDS GLI1 PIK3R1 BRD4 SETBP1 RNASEH2C LPP BUB1 BUB1B SCN9A SCN10A TREM2 MLF1 MLH1 ELANE DKC1 ATM HAX1 RPL35 GNB1 BUB3 CEP57 TAL1 KIT TAL2 RPL5 EP300 TP53 RPL11 KIF11 RPL15 DNMT3A RPL18
Lymphoid leukemia