The study period is from the start of study treatment, cycle 1 day 1 until 28 days after the last treatment dose. (Cycle 5 day 9). Treatment will be continued until cycle 5 is completed or the study is terminated for the patient. The cycles will be repeated every 28 days. Cycle 1 Day 1 of study treatment will be between day +30 and day +45 post-transplant. Each 28-day cycle is comprised of Pevonedistat at 20 mg/m2 IV infusion over 1 hour on days 1, 3 and 5 and Azacitidine at 25 mg/m2 IV infusion over 30 minutes on days 1, 2, 3, 4, 5, 8 and 9. The drugs can be administered either through a central catheter or a peripheral line.

Acute Myeloid Leukemia (AML)

To assess the toxicity and efficacy of a combination of Pevonedistat and Azacitidine as post allogeneic hematopoietic stem cell transplant maintenance therapy for non-remission AML.

Pevonedistat

Although hematopoietic stem cell transplantation (HSCT) is curative for many patients with AML, AML in relapse at the time of transplant is still a major challenge with low rates of leukemia-free survival even with an intensive myeloablative conditioning.

transplant

Azacitidine

Penn State Hershey Medical Center: Penn State Cancer Institute

Pevonedistat and Azacitidine as Maintenance Therapy After Allogeneic Stem Cell Transplantation for Non-Remission AML

A Phase II Study of Pevonedistat (MLN4924, TAK924) and Azacitidine as Maintenance Therapy After Allogeneic Stem Cell Transplantation for Non-Remission Acute Myelogenous Leukemia

Cumulative incidence of relapse at 2 years

Shin Mineishi

Professor and Director, Blood and Marrow Transplant Program

Milton S. Hershey Medical Center

Millennium Pharmaceuticals, Inc.

Takeda

Acute Myelogenous Leukemia

Acute Lymphoblastic Leukemia

Chronic Myelogenous Leukemia

High-risk Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Advanced Myelofibrosis

TH-302 will be administered as a 30-minute intravenous infusion daily for 5 days every 21 days. Patients who successfully complete a 3-week treatment cycle without evidence of significant treatment-related toxicity or clinically significant progressive disease will continue to receive treatment for up to six cycles.

TH-302

University of Texas M.D. Anderson Cancer Center

Study of Hypoxia-Activated Prodrug TH-302 to Treat Advanced Leukemias

A Phase I Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of TH-302, a Hypoxia-Activated Prodrug, in Patients With Advanced Leukemias

Threshold Pharmaceuticals

myelodysplastic syndromes

hypoxia

myelodysplastic syndromes/hypoxia

Pevonedistat and Azacitidine as Maintenance Therapy After Allogeneic Stem Cell Transplantation for Non-Remission AML

Study of Hypoxia-Activated Prodrug TH-302 to Treat Advanced Leukemias

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