Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Azacitidine

Decitabine

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antimetabolites

Enzyme Inhibitors

Vidaza consists of 50 mg/ m2 s.c or i.v for 7 days (5 + weekend off + 2) every 28 days and increase after 1st cycle, if well tolerated, to 75 mg/m2 s.c or i.v. for 7 days (5 + weekend off + 2) every 28 days for further 5 cycles followed by cycles every 56 days for 4 years and six months

1st cycle 50 mg/sqm s.c. or i.v. for 7 days (5 + weekend off + 2) every 28 days and increase dosing after 1st cycle, if well tolerated, to 75 mg/ m2 for further 5 cycles, followed by cycles every 56 days for 4 years and six months post-remission.

Vidaza 100 milligram (mg) injection

Best supportive care includes antibiotics, transfusions and fluids

Best Supportive Care

Esther Natalie Oliva

The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged \>60 years, who have achieved complete remission (CR) following conventional induction ('3+7') and consolidation chemotherapy.

The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged \>60 years, who have achieved CR following conventional induction ('3+7') and consolidation chemotherapy to evaluate 2 an 5 year post-remission rates of Overall Survival and disease free survival between two arms

Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients

A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients

Disease-free survival (DFS) at 2 and 5 years. Events for DFS are death and first relapse (either AML or myelodysplastic syndrome (MDS) recurrence) and death; observations are censored at the date of last contact if alive and disease-free. DFS will be calculated from the date of achievement of CR to the date of 1st relapse or death. Patients still alive in 1st CR will be censored at the moment of last visit/contact.

Number and length of hospitalizations in the post-remission period.

Overall survival (OS) at 2 and 5 years. Event for OS in both arms is death and patients are censored at the date of last contact if alive

Associazione Qol-one

Cytarabine

Daunorubicin

Plerixafor

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

240 mcg/kg/dose and proceeding to escalating dose levels for determination of the single-dose maximum tolerated dose (MTD) provided that there are no unacceptable dose limiting toxicities

Medical Monitor

The purpose of this research study is to determine if plerixafor can make cells more sensitive to killing by cytarabine and daunorubicin, an anti-cancer drug regimen referred to as "7+3" that is commonly used in treating acute myeloid leukemia (AML). In this study, plerixafor is used with treatments cytarabine and daunorubicin and with and without granulocyte-colony stimulating factor (GCSF). Subjects will be monitored to see how well they tolerate the use of these drugs together and how well they work to treat the leukemia.

The purpose of the study is to determine the maximum tolerated dose (MTD) per plerixafor dosing schedule (once daily \[QD\] or twice daily \[BID\]), and/or recommended phase 2 dose (RP2D), by assessing safety and tolerability of plerixafor (Mozobil®) when used in combination with cytarabine and daunorubicin, and with and without granulocyte-colony stimulating factor (G-CSF)

Study of Plerixafor Combined With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase I, Dose Escalation Study of Plerixafor in Combination With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia

Genzyme, a Sanofi Company

Midostaurin

Protein Kinase Inhibitors

Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily.

Novartis Pharmaceuticals

This was a non-interventional, retrospective registry study, utilizing electronic health record (EHR) data collected in the hospital district of Helsinki and Uusimaa (HUS). Real-world health care resource utilization (HCRU) of AML patients was characterized.

Adult patients (18 years or older) with the inclusion diagnosis, AML (ICD-10 C92.0), between 1.1.2013 - 30.6.2020 were followed from the index date (first ever record of the inclusion diagnosis) until the end of follow-up (30.6.2020), or death. This study did not involve any contacts to patients.

The study inclusion period was changed from 1.1.2013 - 30.6.2020 specified in the protocol to 1.1.2016 - 30.6.2020 due to lack of medication data from pre-2016.

Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)

Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML) With a Focus on Patients Treated With Rydapt (Midostaurin) in Helsinki and Uusimaa Hospital District

Number of patients initiating midostaurin treatment were reported.

Number of patients who received Midostaurin at induction and consolidation phases were reported.

Duration of Midostaurin at induction and consolidation phase were reported.

Median average dose intensity in midostaurin treatment were reported.

Most frequent comorbidities at the time of AML diagnosis were reported.

Number of patients at the time of diagnosis (All treated AML patients) were reported.

Number of AML patients receiving midostaurin consolidation treatment in inpatient or outpatient care (based on given prescriptions) were reported.

Estimate HCRU and related costs in different disease stages were reported.

Symptoms and General Pathology

Recurrence

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

The patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine. The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1.4g/m2/d for 5 days intravenously.

The patients in control arm should receive the consolidation chemotherapy regimen with high-dose cytarabine. The dosage of cytarabine is 2000mg/m2/12h for 3 days (1,3,5) intravenously.

50 mg/m2, IV (in the vein) in combination with cytarabine 1.4mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4

2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4

Xianmin Song, Doctor

Xianmin Song

The purpose of the study is to determine whether Fludarabine in combination with cytarabine is more effective than high-dose cytarabine in post-remission therapy for patients with AML1-ETO acute myeloid leukemia.

AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy

A Randomized Comparison of Fludarabine in Combination With Cytarabine Versus High -Dose Cytarabine in Post-remission Therapy for AML1-ETO Acute Myeloid Leukemia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients	NCT05188326	Acute Myeloid L...	Vidaza 100 mill... Best Supportive...	61 Years -	Associazione Qol-one
Study of Plerixafor Combined With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia	NCT00990054	Acute Myeloid L...	Plerixafor	18 Years - 70 Years	Sanofi
Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)	NCT05488613	Acute Myeloid L...	Midostaurin	18 Years - 99 Years	Novartis
Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)	NCT05488613	Acute Myeloid L...	Midostaurin	18 Years - 99 Years	Novartis
AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy	NCT02024308	Acute Myeloid L... AML1-ETO Fusion...	Fludarabine Cytarabine	18 Years - 65 Years	Changhai Hospital
AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy	NCT02024308	Acute Myeloid L... AML1-ETO Fusion...	Fludarabine Cytarabine	18 Years - 65 Years	Changhai Hospital

Spots Global Cancer Trial Database for acute myeloid leukemia,