Raw Ground Truth
Inclusion Criteria:Males and females greater than or equal to (>=)18 years of age (at the time consent is obtained).Diagnosis of MDS, CMML or AMLEastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2Adequate organ functionA woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test within 7 days before the first dose of study intervention.Exclusion Criteria:History of, or known, central nervous system (CNS) involvementPrior solid organ transplantationKnown allergies, hypersensitivity, or intolerance to GSK3326595 or 5-Azacitidine or its excipientPrior therapy with any Protein arginine methyl transferase 5 (PRMT5) inhibitorHistory of a second malignancy, excluding non-melanoma skin cell cancer, within the last three yearsActive severe or uncontrolled infectionHistory of optic nerve neuropathy or neuritis.History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Raw Prediction
Inclusion Criteria:
- Males and females greater than or equal to (>=) 18 years of age (at the time consent is obtained).
- Diagnosis of MDS, CMML, or AML.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Adequate organ function.
- A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test within 7 days before the first dose of study intervention.
- Treatment naïve MDS and CMML participants are now included in the Part 2 Dose Expansion cohorts.
Exclusion Criteria:
- History of, or known, central nervous system (CNS) involvement.
- Prior solid organ transplantation.
- Known allergies, hypersensitivity, or intolerance to GSK3326595 or 5-Azacitidine or its excipient.
- Prior therapy with any Protein arginine methyl transferase 5 (PRMT5) inhibitor.
- History of a second malignancy, excluding non-melanoma skin cell cancer, within the last three years.
- Active severe or uncontrolled infection.
- History of optic nerve neuropathy or neuritis.
- History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- Additional prohibited medications (strong/moderate inhibitors or inducers of MATE2-K, OAT3, and OCT2 transporters) as identified in the latest supplement to the Investigator Brochure.
Processed Ground Truth
1. Males and females greater than or equal to (>=)18 years of age (at the time consent is obtained).Diagnosis of MDS, CMML or AMLEastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2Adequate organ functionA woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test within 7 days before the first dose of study intervention.Exclusion Criteria:History of, or known, central nervous system (CNS) involvementPrior solid organ transplantationKnown allergies, hypersensitivity, or intolerance to GSK3326595 or 5-Azacitidine or its excipientPrior therapy with any Protein arginine methyl transferase 5 (PRMT5) inhibitorHistory of a second malignancy, excluding non-melanoma skin cell cancer, within the last three yearsActive severe or uncontrolled infectionHistory of optic nerve neuropathy or neuritis.History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Processed Prediction
1. Males and females greater than or equal to (>=) 18 years of age (at the time consent is obtained).
2. Diagnosis of MDS, CMML, or AML.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
4. Adequate organ function.
5. A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test within 7 days before the first dose of study intervention.
6. Treatment naïve MDS and CMML participants are now included in the Part 2 Dose Expansion cohorts.
1. History of, or known, central nervous system (CNS) involvement.
2. Prior solid organ transplantation.
3. Known allergies, hypersensitivity, or intolerance to GSK3326595 or 5-Azacitidine or its excipient.
4. Prior therapy with any Protein arginine methyl transferase 5 (PRMT5) inhibitor.
5. History of a second malignancy, excluding non-melanoma skin cell cancer, within the last three years.
6. Active severe or uncontrolled infection.
7. History of optic nerve neuropathy or neuritis.
8. History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
9. Additional prohibited medications (strong/moderate inhibitors or inducers of MATE2-K, OAT3, and OCT2 transporters) as identified in the latest supplement to the Investigator Brochure.