Single Agent Decitabine in TP53 Mutated Relapsed/Refracto... | NCT03063203

ID	Type	Description	Link
3P50CA171963-06S1	U.S. NIH Grant/Contract		View source

Name	Class
Janssen Pharmaceuticals	INDUSTRY
National Institutes of Health (NIH)	NIH
National Cancer Institute (NCI)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Decitabine	Experimental	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle	Drug: Decitabine Procedure: Bone marrow biopsy/aspirate Procedure: Peripheral blood draw Procedure: Skin biopsy Procedure: Buccal swab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Decitabine	Drug	After 2 cycles, patients with progressive disease or relapse (a clear progression with at least >20% bone marrow blasts and an increase of at least 50% from prior biopsy) should be removed from protocol and proceed to salvage treatment according to center preference Transplant eligible patients who achieve CR, CRc, or CRi, after 3 cycles with a suitable donor will proceed to conditioning regimen and transplant Transplant eligible patients with PR after 3 cycles may be removed from protocol and proceed to salvage treatment according to center preference Transplant eligible patients with a suitable donor who achieve mLFS, CR, CRc, or CRi, may proceed to transplant after at 3 cycles Transplant ineligible patients with (CR, CRc or CRi, PR) will continue on maintenance doses Transplant ineligible patient with SD after cycle 4 may be removed from protocol and proceed to alternative treatment or continue on protocol according to treating physician's preference.

Measure	Description	Time Frame
Overall Survival of Participants With TP53 Mutation	Overall survival (OS) is defined as the time from enrollment to death due to any cause. For a patient who is not known to be alive at the end of study follow up, observation of OS is censored on the date the patient was last known to be alive To be evaluable for this outcome measure the participant would have to have received at least one dose of decitabine	1 year

Measure	Description	Time Frame
Percentage of Responding TP53 Mutated Patients (CR, CRi)	Complete remission (CR) - Defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 109/L (1,000/μL); platelet count >100 x 109/L (100,000/μL). Complete remission with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia - <1.0 x 109/L (1,000/μL) or thrombocytopenia -<100 x 109/L (100,000/μL)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

TP53 mutant AML. The presence of a TP53 mutation should be determined by Genoptix (or institutional preferred equivalent assay). Detection of a TP53 mutation at the time of initial diagnosis is sufficient for enrollment at the time of relapsed/refractory disease. Detection of a TP53 mutation in either the peripheral blood or bone marrow is adequate for enrollment. Alternatively, patients who have not had TP53 mutation analysis performed, but who have > 20% TP53 positive cells by immunohistochemistry detected on a bone marrow aspirate may also be enrolled,29 provided that mutation analysis is requested at the time of enrollment.
Relapsed/refractory AML following 7+3 (or similar cytarabine containing induction chemotherapy for AML) disease detected by one of the following methods:
- bone marrow blasts > 5%, or
- Hematologics flow cytometry assay (threshold > 0.5%) (alternative equivalent assay may be substituted), or
- Persistent cytogenetic abnormality (e.g. del5, del17p, etc), by FISH or conventional karotyping, or
- Persistent TP53 mutation (at least 5 variant reads with at least 50x coverage) determined by Genoptix (or institutional preferred equivalent assay).
Patients with > 10% blasts on a day +14 bone marrow biopsy following 7+3 may either be enrolled or may be treated with a course of standard re-induction (e.g. 5+2 or similar) and then re-evaluated for response. Eligible patients will meet any of the above criteria on a subsequent biopsy.
Bone marrow and organ function as defined below:
- Peripheral white blood cell count < 50,000/mcl (patients may receive hydroxyurea as necessary for cytoreduction),
- Total bilirubin < 1.5 x upper limit of normal,
- AST and ALT < 2.5 x upper limit of normal,
- Serum creatinine < 2.0 x upper limit of normal, and,
At least 18 years of age.
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable
Performance status ≤ 3

Exclusion Criteria:

Prior treatment with either decitabine or azacitidine or an investigational agent
Acute promyelocytic leukemia with PML-RARA or t(15;17).
History of HIV, Hepatitis B, or Hepatitis C infection.
Concurrent illness including, but not limited to, ongoing uncontrolled infection, symptomatic NYHA class 3 or 4 congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Radiation therapy within 14 days of enrollment.
Chemotherapy administration in the 7 days preceding enrollment with the exception of hydroxyurea, which can be continued until Cycle 2. A washout period for oral tyrosine kinase inhibitors (e.g. Jakafi, etc) is not required, although tyrosine kinase inhibitors therapy must be discontinued prior to enrollment.
Malignancies (other than AML) requiring active therapy or diagnosed within the last year, with the exception of non-melanoma skin cancer which can be treated or in situ malignancies (such as cervical, breast, prostate, etc.)
Currently receiving any other investigational agents.
Known central nervous system (CNS) leukemia or testicular involvement of leukemia
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine or other agents used in the study.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 7 days of study entry.

Name	Affiliation	Role
John Welch, M.D., Ph.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

Label	URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine	View source

ID	Title	Description
FG000	Decitabine	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 1, 2020

ID	Title	Description
BG000	Decitabine	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Units	Counts
Participants	BG00017

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival of Participants With TP53 Mutation

Overall survival (OS) is defined as the time from enrollment to death due to any cause. For a patient who is not known to be alive at the end of study follow up, observation of OS is censored on the date the patient was last known to be alive
To be evaluable for this outcome measure the participant would have to have received at least one dose of decitabine

Posted

Median

95% Confidence Interval

days

1 year

ID	Title	Description
OG000	Decitabine	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Units	Counts
Participants	OG00017

Title

Denominators

Categories

Title	Measurements
	OG000244(116 to 390)

Secondary

Percentage of Responding TP53 Mutated Patients (CR, CRi)

Complete remission (CR) - Defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 109/L (1,000/μL); platelet count >100 x 109/L (100,000/μL).
Complete remission with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia - <1.0 x 109/L (1,000/μL) or thrombocytopenia -<100 x 109/L (100,000/μL)

Posted

Count of Participants

Participants

12 weeks

ID	Title	Description
OG000	Decitabine	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Units	Counts
Participants	OG000

Secondary

Time to Stem Cell Transplant Among Participants Who Are Suitable Candidates for Transplant and Have an Identified Donor

Document the number of days that it takes each participant to reach transplant
Transplant eligible participants are those who achieve complete remission (CR), cytogenetic complete remission (CRc), complete remission with incomplete hematologic recovery (CRi), or morphologic leukemia free state (mLFS) per 2017 ELN AML Recommendations.

Posted

Median

Full Range

days

12 weeks

ID	Title	Description
OG000	Decitabine	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Units	Counts
Participants	OG000

Secondary

Median Time to Leukemia Relapse (TTLR) in Non-transplant Patients

-Recurrence/morphologic relapse - Defined as relapse following complete remission is defined as reappearance of blasts in the blood or the finding of ≥ 5% blasts in the bone marrow, not attributable to any other cause. New dysplastic changes is considered relapse. If there are no blasts in the peripheral blood and 5-20% blasts in the bone marrow, bone marrow biopsy should be repeated in > 1 week to confirm relapse.

Posted

Median

Full Range

days

2 years

ID	Title	Description
OG000	Decitabine	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Units	Counts
Participants	OG000

Secondary

Event-free Survival (EFS)

-Event-free survival is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, death due to any cause, or loss to follow up.

Posted

Median

95% Confidence Interval

days

2 year

ID	Title	Description
OG000	Decitabine	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Units	Counts
Participants	OG000

Secondary

Average Number of Hospital Days

-Document number of hospital days that each participant stays and obtain average for all evaluable participants

Posted

Mean

Full Range

days

During cycles 1 and 2 (60 days)

ID	Title	Description
OG000	Decitabine	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Units	Counts
Participants	OG000

Secondary

Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment

Morphologically evident disease (>5% blasts by cytomorphology)
Molecularly detected disease (disease detected with flow cytometry, cytogenetic, or mutational analysis if ≤ 5% blasts by cytomorphology)
Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations

Response was not evaluable for 2 patients with molecularly evident disease as their samples were hemodilute. Response was not evaluable for 1 patient with molecularly detected disease as their sample was hemodilute.

Posted

Count of Participants

Participants

Through 12 weeks

ID	Title	Description
OG000	Morphologically Evident Disease	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle
OG001	Molecularly Detected Disease	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Secondary

Survival Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment

Morphologically evident disease (>5% blasts by cytomorphology)
Molecularly detected disease (disease detected with flow cytometry, cytogenetic, or mutational analysis with ≤ 5% blasts by cytomorphology)

Posted

Median

95% Confidence Interval

days

2 years

ID	Title	Description
OG000	Morphologically Evident Disease	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle
OG001	Molecularly Detected Disease	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Secondary

Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML

-Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations

2 patients with de novo AML were not evaluable for this outcome measure because the samples were hemodilute. 1 patient with treatment related AML was not evaluable for this outcome measure because the samples were hemodilute.

Posted

Count of Participants

Participants

Through 12 weeks

ID	Title	Description
OG000	Patients With de Novo AML	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle
OG001	Patients With Secondary AML	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Secondary

Survival Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML

Posted

Median

95% Confidence Interval

days

2 years

ID	Title	Description
OG000	Patients With de Novo AML	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle
OG001	Patients With Secondary AML	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle
OG002	Patients With Treatment Related AML

Secondary

Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations

-Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations

Response was not evaluable for 3 patients with presence of cytogenetic abnormalities in addition to TP53 mutations as their response samples were hemodilute.

Posted

Count of Participants

Participants

12 weeks

ID	Title	Description
OG000	Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle
OG001	Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Secondary

Survival Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations

Posted

Median

95% Confidence Interval

days

2 years

ID	Title	Description
OG000	Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle
OG001	Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Secondary

Median Number of Hospital Stays

-Document number of hospital days that each participant stays and obtain median for all evaluable participants

Posted

Median

Full Range

days

During cycles 1 and 2 (60 days)

ID	Title	Description
OG000	Decitabine	Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle. Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Febrile neutropenia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0004 affected17 at risk
Chest tightness	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Chest pain - cardiac	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Heart failure	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Ear pain	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Diplopia	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Conjunctivitis	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Heartburn	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected17 at risk
Dyspepsia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Gastrointestinal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected17 at risk
Oral pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Stomach pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Toothache	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected17 at risk
Knots	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Injection site reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Localized edema - right breast	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Chills	General disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected17 at risk
Edema limbs	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Fatigue	General disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected17 at risk
Fever	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Infusion related reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Non-cardiac chest pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Cellulitis on shin	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Staphylococcus epidermis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Thrush	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Sepsis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Upper respiratory infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Alanine aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0004 affected17 at risk
Alkaline phosphatase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected17 at risk
Aspartate aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0004 affected17 at risk
Blood bilirubin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Cardiac troponin I increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Creatinine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Lymphocyte count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0009 affected17 at risk
Neutrophil count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0006 affected17 at risk
Platelet count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0005 affected17 at risk
Weight loss	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
White blood cell decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0007 affected17 at risk
Acidosis	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Hypermagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Hypernatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected17 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Hypomagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected17 at risk
Hypophosphatemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Hip pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Shoulder pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Neck pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected17 at risk
Dysgeusia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected17 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Tremor	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Confusion	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Delirium	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Hallucinations	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Insomnia	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Acute kidney injury	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected17 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected17 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Oily skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Traumatic fat necrosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Rash maculopapular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected17 at risk
Hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Hypotension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D001374	Azacitidine
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bacteremia streptococcus	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Facial cellulitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Febrile neutropenia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected17 at risk
Sinusitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk
Thromboembolic event	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected17 at risk