SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03737955

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 2 Trial of Fractionated Gemtuzumab Ozogamicin to Eradicate Measurable Residual Disease in Acute Myeloid Leukemia Patients (GO for MRD)

This phase II trial studies how well fractionated gemtuzumab ozogamicin works in treating measurable residual disease in participants with acute myeloid leukemia. Antibody-drug conjugates, such as gemtuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells.

NCT03737955 Acute Myeloid Leukemia CD33 Positive Minimal Residual Disease
MeSH: Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasm, Residual
HPO: Acute megakaryocytic leukemia Acute myeloid leukemia Leukemia Myeloid leukemia

2 Interventions

Name: Gemtuzumab Ozogamicin

Description: Receive IV

Type: Drug

Treatment (gemtuzumab ozogamicin)

Name: Quality-of-Life Assessment

Description: Ancillary studies

Type: Other

Treatment (gemtuzumab ozogamicin)


Primary Outcomes

Description: Measured by clearance of measurable residual disease (MRD) with bone marrow evaluation after one or two cycles of therapy and compare responses (rate of eradication of MRD) based on CD33 single nucleotide polymorphism rs12459419 genotype.

Measure: Clinical response rate

Time: Up to 70 days

Secondary Outcomes

Description: Measured by grade III/IV non-hematologic toxicities using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.

Measure: Rate of sinusoidal obstructive syndrome (SOS)

Time: Up to 6 months

Description: Measured by those receiving HCT

Measure: Rate of allogeneic hematopoietic cell transplantation (HCT)

Time: Up to 6 Months

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 rs12459419

Measured by clearance of measurable residual disease (MRD) with bone marrow evaluation after one or two cycles of therapy and compare responses (rate of eradication of MRD) based on CD33 single nucleotide polymorphism rs12459419 genotype.. Rate of sinusoidal obstructive syndrome (SOS).



HPO Nodes


HPO:
Acute megakaryocytic leukemia
Genes 1
GATA1
Acute myeloid leukemia
Genes 29
MPL MLF1 NSD1 JAK2 KRAS NPM1 ELANE DKC1 ETV6 TCIRG1 DNAJC21 SRP54 EFL1 FLT3 NUP214 CEBPA THPO MLLT10 RUNX1 PIGA CBFB BRCA2 KIT PICALM SBDS GFI1 SH3GL1 LPP DNMT3A
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
Myeloid leukemia
Genes 12
GATA2 F13A1 CBL ARHGAP26 F13B KRAS PTPN11 SAMD9L KIT SETBP1 NF1 NRAS