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

Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by a PeerScope System™ extended view colonoscopy.

Group B (control group) will undergo a PeerScope System™ extended view colonoscopy followed immediately by a Standard view colonoscopy.

Colon Polyps and Adenomas

Colon Cancer

endoscopic diagnosis, treatment and video observation of the digestive tract, endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients

Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system

North Shore Gasstroenterology Assoiates, P.C.

Southshore Gasstroenterology, P.C

Carmel Medical Center

Elisha Medical Center

The Tel Aviv Sourasky Medical Center

Polyp Detection With The Peerscope System™

Polyp Detection With The Peerscope System™: A Randomized Tandem Colonoscopy Study

Sample size calculation is based on detecting a difference in the adenoma overall detection rate and the overall polyp detection rate using the PeerScope System™ extended view as compared to Standard view colonoscopy.
Total sample size will be 196 patients. Each patient will undergo the procedure by the two devices: PeerScope System™ extended view and Standard view colonoscopy. The rational for this sample size is based on detecting a rate difference of 20% between the study devices.

diverticulitis/hypoxia

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

Polyp Detection With The Peerscope System™

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