SNPMiner Trials by Shray Alag

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Report for Mutation S239D

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 ---

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