SNPMiner Trials by Shray Alag


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Report for Mutation I332E

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 Single Agent JNJ-56022473 in MDS and AML Patients Failing Hypomethylating Agent Based Therapy

The outcome of HMA-refractory patients with MDS or AML is dismal with a median survival of 5 months after failure, representing a significant unmet medical need due to the very limited treatment options. In this context, a specific targeting of the leukemic stem cell (LSC) seems a promising option to selectively combat the leukemic progenitor cells. In fact, CD123 is overexpressed in AML and MDS progenitors making it an attractive target for immunotherapy-based approaches. JNJ-56022473 is a promising compound that has been engineered with regard to this strategy and the current phase II trial has the aim to evaluate the overall hematological response rate at 3 months in HMA refractory/relapsed AML and MDS patients.

NCT02992860 Myelodysplastic Syndrome (MDS) Acute Myeloid Leukemia (AML) Drug: JNJ-56022473 Procedure: Bone marrow analyses and CBC with differential Other: Flow cytometry analyses Other: Central biobanking Procedure: Histopathology analysis Genetic: Cytogenetic analysis Procedure: Serum chemistry Procedure: Automated CBC Procedure: Pregnancy Test
MeSH: Leukemia, Myeloid Leukemia, Myeloid, Acute Preleukemia Myelodysplastic Syndromes
HPO: Acute megakaryocytic leukemia Acute myeloid leukemia Myelodysplasia Myeloid leukemia

To enhance the cytotoxicity of the first-generation antibody CSL360, the proprietary Xencor (Xmab®) technology was applied and two amino acid mutations (S239D and I332E) were introduced into the Fc region. --- S239D --- --- I332E ---

Primary Outcomes

Description: Overall hematological response rate at 3 months (either CR, PR, marrow-CR, HI, SD)

Measure: Overall hematological response rate

Time: 3 months

Secondary Outcomes

Description: Toxicity as measured by NCI CTCAE 4.03

Measure: Toxicity

Time: 3 or 12 months

Measure: Overall survival

Time: 1 year

Measure: Progression-free-survival

Time: 1 year

Measure: Overall hematological response rate at 12 months

Time: 1 year

Description: measured by EORTC-QLQ30

Measure: Quality of life EORTC-QLQ30

Time: 9 or 15 months

Measure: Time to treatment failure

Time: 3 or 12 months

Measure: Duration of response (best overall response)

Time: 3 or 12 months


HPO Nodes


Acute myeloid leukemia
Genes 50
KIT DDX41 SBDS LPP ETV6 DNMT3A TERT JAK2 NUP214 CEBPA BRCA2 TCIRG1 DNAJC21 TET2 FLT3 TET2 JAK2 SRP54 SF3B1 SRP54 SH3GL1 KRAS EFL1 PIGA MLLT10 SRP54 DNAJC21 DKC1 RUNX1 RUNX1 MPL CBFB NSD1 THPO ELANE NPM1 ASXL1 CHIC2 MLF1 DNAJC21 ERBB3 GFI1 GFI1 SRSF2 KIT PICALM RPS14 GATA2 SBDS TET2
Myeloid leukemia
Genes 20
KIT SETBP1 NF1 ARHGAP26 CBL TET2 KRAS PTPN11 F13A1 SAMD9L SAMD9L GATA2 CBL ASXL1 DNMT3A F13B NRAS SRSF2 TERC TERT
Myelodysplasia
Genes 93
NAGS MPL SLX4 TET2 TERT TRIP13 DDX41 SBDS TP53 ATRX TET2 SF3B1 BUB1B TCIRG1 DNAJC21 RFWD3 BUB1 TET2 FANCL ATRX ASXL1 TET2 JAK2 SAMD9 SRP54 RPS14 PALB2 GINS1 SMARCD2 GATA2 SF3B1 BUB3 GATA2 SRP54 TET2 FANCB FANCE TET2 FANCM RFWD3 EFL1 RAD51 PIGA SRP54 DNAJC21 RAF1 DKC1 MPL RUNX1 MPL FANCD2 BRAF LIG4 FANCG RECQL4 THPO NBEAL2 CALR JAK2 TERC ERCC4 FANCI ELANE GATA2 SRP72 FANCG ASXL1 FANCC BRCA1 ERBB3 PTPN11 BRIP1 GFI1 SRSF2 HSPA9 KIT HAX1 GFI1B MAD2L2 CEP57 RPS14 FANCF SH2B3 XRCC2 RPS19 TINF2 SBDS TET2 BRCA2 RAD51C UBE2T JAK2 FANCA