Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Daunorubicin

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.

If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.

In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.

If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year

Glasdegib

CPX-351

Chao Family Comprehensive Cancer Center University of California, Irvine

University of California Irvine Medical

Gary Schiller, MD

Deepa Jeyakumar, MD

Brian Jonas, MD, PhD

This is a phase 2 single-arm, open-label clinical trial determining efficacy of CPX-351 in combination with Glasdegib in subjects with Acute Myelogenous Leukemia with myelodysplastic syndrome related changes or therapy-related acute myeloid leukemia.

CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia

Phase II Study of the Combination of CPX-351 and Glasdegib in Previously Untreated Patients With Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia

This is defined as the percentage of subjects with event-free survival (EFS) at 6 months. EFS is defined as the number of months where patients are in a remission state.

To evaluate the tolerability of administering CPX-351 in combination with glasdegib in patients with newly diagnosed with Acute Myeloid Leukemia (AML) with Myelodysplastic Syndrome (MDS) related changes or treatment-related AML from the start of treatment, duration of treatment and up to 4 weeks after completion of study treatment. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.

To assess the overall response rate to the combination of CPX-351 and glasdegib. The overall response rate (ORR) is defined as the rate of complete remissions (CR) and complete remission with incomplete count recovery (CRi). ORR = CR + CRi

Durability of response is measured by relapse-free survival (RFS). RFS is defined as the amount of time a patient remains in remission after having achieved a CR or CRi

To evaluate the overall survival of patients with newly diagnosed with Acute Myeloid Leukemia (AML) with Myelodysplastic Syndrome (MDS) related changes or treatment-related AML.

To evaluate the time to normal hematopoiesis, process by which blood cells are formed, as determined by laboratory studies inclusive of complete blood counts (CBCs)

This is defined as the number of participants who continue on to receive an allogenic hematopoietic stem cell transplant after induction, re-induction, or consolidation.

Jazz Pharmaceuticals

Pfizer

University of California, Irvine

HS Associate Clinical Professor

Spots Global Cancer Trial Database for aml with mds related changes