Acute Myeloid Leukemia Clinical Trial
— AMLOfficial title:
Clinical Factors Associated With the Development of Severe Sepsis in Patients Being Treated for Acute Myeloid Leukemia
Verified date | January 2017 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Acute leukemia is a life threatening illness that strikes people of all ages. In addition to
surviving the direct effects of the disease, the treatment of leukemia generally requires
chemotherapy which has its own burden. Infection is one of the most common secondary
problems faced by these patients. Simple infections are common and easily treated with
aggressive antibiotics. However, treated progressive infection leads to loss of vital organ
function and is termed severe sepsis. Severe sepsis is associated with increased risk of
death and the need for specialized care in the intensive care unit.
Besides the appropriate use of antibiotics, little is known about what clinical and patient
factors are associated with the development of severe sepsis. Recent evidence has suggested
that certain practices like frequent transfusion of blood products and control of glucose
levels effects outcome in critically ill patients. In addition, there have been advances in
our knowledge of certain genes that may predispose people to severe infections. It is
possible that these factors are important in people who are not yet critically ill, but are
at risk for the development of severe sepsis.
This observational study will look at genetic, clinical and therapeutic factors that are
associated with the development of severe sepsis. This will help doctors understand what
treatments may be helpful in preventing this serious complication.
Status | Completed |
Enrollment | 120 |
Est. completion date | May 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - Diagnosis of acute myeloid leukemia - Age = 18 years of age - Plans to receive chemotherapy as an inpatient and remain inpatient until hematologic recovery as determined by the primary treating physician Exclusion criteria: - Subject is unlikely to survive > 3 months with treatment - Current diagnosis of severe sepsis - Subject or surrogate is unable to give informed consent - Subject is incarcerated - Patient's family, physician, or both not in favor of endotracheal intubation or mechanical ventilation for any length of time or the presence of an advanced directive to withhold the same. - Subject currently requiring mechanical ventilation - Subject with current diagnosis of acute lung injury or ARDS (bilateral infiltrates on chest X-ray and PF ratio< 300 with no evidence of left atrial hypertension) - Subject has received chemotherapy for the treatment of AML > 96 hours ago. |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | determine the true relationship of hyperglycemia to the development of severe sepsis after chemotherapy for AML | end of study |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Recruiting |
NCT04460235 -
Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma
|
Phase 4 | |
Completed |
NCT04022785 -
PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
Completed |
NCT03678493 -
A Study of FMT in Patients With AML Allo HSCT in Recipients
|
Phase 2 | |
Recruiting |
NCT05424562 -
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
|
||
Terminated |
NCT03224819 -
Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)
|
Early Phase 1 | |
Completed |
NCT03197714 -
Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia
|
Phase 1 | |
Active, not recruiting |
NCT04070768 -
Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Active, not recruiting |
NCT04107727 -
Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)
|
Phase 2 | |
Recruiting |
NCT04920500 -
Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients
|
N/A | |
Recruiting |
NCT04385290 -
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
|
Phase 1/Phase 2 | |
Recruiting |
NCT03897127 -
Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics
|
Phase 3 | |
Active, not recruiting |
NCT04021368 -
RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome
|
Phase 1 | |
Recruiting |
NCT03665480 -
The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML
|
Phase 2/Phase 3 | |
Completed |
NCT02485535 -
Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant
|
Phase 1 | |
Enrolling by invitation |
NCT04093570 -
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
|
Phase 2 | |
Recruiting |
NCT04069208 -
IA14 Induction in Young Acute Myeloid Leukemia
|
Phase 2 | |
Recruiting |
NCT05744739 -
Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)
|
Phase 1 | |
Recruiting |
NCT04969601 -
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings
|
Phase 1/Phase 2 |