Health Condition 1: D728- Other specified disorders of whiteblood cells
Conditions
Sponsors
Tata Trusts
Eligibility
Inclusion criteria
Inclusion criteria: Cytologically or histologically confirmed diagnosis of AML & MDS-EB2 (except acute promyelocytic leukemia and therapy related AML/MDS)
Exclusion criteria
Exclusion criteria: Refractory AML and BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe proportion of patients with adequate â??individualâ?? Comprehensive Genomic profiling (genome, methylome, etc.). To describe MRD information of patients undergoing therapy for AML/MDS-EB by Standardized and validated MRD assays. To establish and report patient specific Computational drug models using individual patient derived comprehensive genomic information. Timepoint: first one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Describe the Alpha and beta diversity of microbiome within patients at different time points and between patients 30-day all-cause mortality Composite Response Rates including MRD Duration of CR 2y OS 2y PFS Incidence and severity of adverse events. [Subject and investigator-observed AEs] MDRO colonization rate of patients To correlate patient clinical outcomes with background Genomics, MRD and Microbiome InformationTimepoint: 2nd year | — |
Countries
India
Contacts
Public ContactDr Vivek S Radhakrishnan
Tata Medical Center, Kolkata
Outcome results
None listed