Trial Outcomes & Findings for AKT Inhibitor MK-2206 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT01253447)

Last Updated: 2018-08-27

Results Overview

Responses defined by International Working Group (IWG) 2003 Response Criteria: Morphologic Complete Response (CR): Peripheral blood counts: No circulating blasts, Neutrophil count \>/= 1.0 x10\^9/L, Platelet count \>/= 100 x10\^9/L; Bone marrow aspirate and biopsy: \</= 5% blasts, No detectable Auer rods, No extramedullary leukemia. Partial Response (PR): No circulating blasts, Neutrophil count \>/=1.0 x10\^9/L, Platelet count \>/= 100 x10\^9/L, \>/= 50 % reduction in bone marrow blast to 6% to 25%, or blasts \</= 5% if Auer rods are present. Morphologic CR with incomplete count recovery (CRp): All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

12 weeks of treatment

Results posted on

2018-08-27

Participant Flow

Recruitment Period: October 27, 2010 to October 30, 2012. All recruitment done in medical clinics, either UT MD Anderson Cancer Center or Fred Hutchinson Cancer Research Center.

Participant milestones

Participant milestones
Measure	Treatment (Akt Inhibitor MK2206) Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
Overall Study STARTED	19
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Akt Inhibitor MK2206) Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
Overall Study Adverse Event	2

Baseline Characteristics

AKT Inhibitor MK-2206 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Akt Inhibitor MK2206) n=19 Participants Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
Age, Continuous	72 years n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	16 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	19 participants n=99 Participants

PRIMARY outcome

Timeframe: 12 weeks of treatment

Population: No participant was not evaluable for response.

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206) n=18 Participants Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
Number of Participants With a Response of CR, CRp, or PR CR	0 participants
Number of Participants With a Response of CR, CRp, or PR CRp	1 participants
Number of Participants With a Response of CR, CRp, or PR PR	0 participants

PRIMARY outcome

Timeframe: Up to 30 days post-treatment

Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 4.0 (CTCAEv4.0)

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206) n=18 Participants Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
Number of Participants With Treatment-related Non-hematological Toxicity Neutropenic Fever	2 Participants
Number of Participants With Treatment-related Non-hematological Toxicity Documented infection	6 Participants
Number of Participants With Treatment-related Non-hematological Toxicity Pneumonia	2 Participants
Number of Participants With Treatment-related Non-hematological Toxicity Fever of Unknown Origin	2 Participants
Number of Participants With Treatment-related Non-hematological Toxicity QTc Prolongation	4 Participants
Number of Participants With Treatment-related Non-hematological Toxicity Maculopapular Rash	10 Participants
Number of Participants With Treatment-related Non-hematological Toxicity Hyperglycemia	12 Participants
Number of Participants With Treatment-related Non-hematological Toxicity Posterior reversible encephalopathy (PRES Syndrome	1 Participants

SECONDARY outcome

Timeframe: Baseline to 12 courses

Population: The Assay did not work so no comparison can be made.

Peripheral blood Acute Myeloid Leukemia (AML) cells (total 2 x 10\^6) used to determine induction of apoptosis in AML stem cells by 4-color flow cytometry assay (CD34/CD38/CD123/annexin). Two-sample t-test conducted to compare changes between the responders and non-responders. Responders are participants who obtain a CR, CRp, or PR, with or without cytogenetic response.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Akt Inhibitor MK2206)

Serious events: 12 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Akt Inhibitor MK2206) n=19 participants at risk Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
Infections and infestations Anorectal infection	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Musculoskeletal and connective tissue disorders Back pain	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
General disorders Fatigue	15.8% 3/19 • Number of events 3 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Infections and infestations Febrile neutropenia	26.3% 5/19 • Number of events 6 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Metabolism and nutrition disorders Hyperglycemia	26.3% 5/19 • Number of events 6 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Metabolism and nutrition disorders Hyperkalemia	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Metabolism and nutrition disorders Hypertension	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Infections and infestations Infections	10.5% 2/19 • Number of events 2 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Blood and lymphatic system disorders Leukocytosis	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Respiratory, thoracic and mediastinal disorders Lung infection	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Cardiac disorders Myocardial infarction	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Blood and lymphatic system disorders Neutrophil count decreased	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Investigations Pain in extremity	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Blood and lymphatic system disorders Platelet count decreased	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Pruritus	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Rash acneiform	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Rash maculo-papular	21.1% 4/19 • Number of events 4 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Respiratory, thoracic and mediastinal disorders Bilateral carck in lungs	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Nervous system disorders Reversible posterior leukoencephalopathy syndrome	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Infections and infestations Sepsis	15.8% 3/19 • Number of events 3 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Mucor fungal infection	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Infections and infestations Soft Tissue Infection (cellulitis)	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.

Other adverse events

Other adverse events
Measure	Treatment (Akt Inhibitor MK2206) n=19 participants at risk Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
Gastrointestinal disorders Anorexia	10.5% 2/19 • Number of events 2 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Psychiatric disorders Anxiety	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Musculoskeletal and connective tissue disorders Back Pain	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Musculoskeletal and connective tissue disorders Bone Pain	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Bruising	10.5% 2/19 • Number of events 2 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Investigations Chills	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Respiratory, thoracic and mediastinal disorders Cough	21.1% 4/19 • Number of events 4 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Metabolism and nutrition disorders Creatinine increased	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Psychiatric disorders Depression	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Gastrointestinal disorders Diarrhea	52.6% 10/19 • Number of events 11 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Nervous system disorders Dizziness	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Dry skin	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Respiratory, thoracic and mediastinal disorders Dyspnea	52.6% 10/19 • Number of events 11 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Blood and lymphatic system disorders Edema limbs	15.8% 3/19 • Number of events 3 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Cardiac disorders Electrocardiogram QT corrected interval prolonged	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Endocrine disorders Hidradenitis	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
General disorders Epistaxis	15.8% 3/19 • Number of events 3 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Injury, poisoning and procedural complications Fall	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
General disorders Fatigue	42.1% 8/19 • Number of events 8 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Investigations Fever	15.8% 3/19 • Number of events 3 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Flushing	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Musculoskeletal and connective tissue disorders Gait disturbance	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Gastrointestinal disorders Poor Appetitue, Gastrointestinal	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Nervous system disorders Headache	15.8% 3/19 • Number of events 3 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Ear and labyrinth disorders Hearing impaired	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Renal and urinary disorders Hematuria	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Gastrointestinal disorders Hemorrhoids	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Metabolism and nutrition disorders Hyperglycemia	68.4% 13/19 • Number of events 26 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Metabolism and nutrition disorders Hypokalemia	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Infections and infestations Throat Yeast infection	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Psychiatric disorders Insomnia	10.5% 2/19 • Number of events 2 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Nervous system disorders Intracranial hemorrhage	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Investigations Pancytopenia	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Psychiatric disorders Irritability	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Respiratory, thoracic and mediastinal disorders Laryngitis	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Gastrointestinal disorders Mucositis oral	10.5% 2/19 • Number of events 2 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Gastrointestinal disorders Nausea	10.5% 2/19 • Number of events 2 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Gastrointestinal disorders Oral hemorrhage	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Musculoskeletal and connective tissue disorders Pain	10.5% 2/19 • Number of events 5 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Eye disorders Periorbital edema	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Pruritus	21.1% 4/19 • Number of events 4 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Rash maculo-papular	26.3% 5/19 • Number of events 6 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Renal and urinary disorders acute renal insufficiency, elevated creatinine	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Cardiac disorders Sinus tachycardia	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Night Sweats	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Petechiae	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Skin ulceration	15.8% 3/19 • Number of events 3 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Skin and subcutaneous tissue disorders Leukemia Cutis	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Gastrointestinal disorders Sore throat	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Nervous system disorders Tremor	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Renal and urinary disorders Urinary frequency	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Renal and urinary disorders Urinary tract pain	5.3% 1/19 • Number of events 1 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Gastrointestinal disorders Vomiting	10.5% 2/19 • Number of events 2 • Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.

Additional Information

Marina Konopleva, MD, PHD / Professor

The University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60