NCT01519648

Brief Summary

Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
808

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

July 18, 2014

Completed
Last Updated

July 25, 2014

Status Verified

July 1, 2014

Enrollment Period

1.7 years

First QC Date

January 23, 2012

Results QC Date

June 18, 2014

Last Update Submit

July 18, 2014

Conditions

Invasive Fungal Infections

Keywords

Invasive fungal infectionAcute leukemia (AL)Hematopoietic stem cell transplantationAntifungal stewardshipNeutropeniaHematological malignancies

Outcome Measures

Primary Outcomes (1)

  • The Rate of Invasive Fungal Infections

    Estimate the rate of IFIs in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.

    6 month

Study Arms (2)

Acute leukemia patients

Patients with de novo or relapsed acute myeloid and lymphoid leukemia

Allo- or auto- transplant recipients

Eligibility Criteria

Age1 Year - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This observational study will be implemented in the hematology departments or hematology centers with or without HSCT located throughout Russia.

You may qualify if:

  • Diagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy
  • All newly allogeneic or autologous transplant recipients during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Hematological Society

Moscow, 119021, Russia

Location

MeSH Terms

Conditions

Invasive Fungal InfectionsNeutropeniaHematologic Neoplasms

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersNeoplasms by SiteNeoplasms

Results Point of Contact

Title
Professor Galina A Klyasova
Organization
National Hematological Society
klyasova.g@blood.ru
+7(495)6125181

Study Officials

  • Galina A Klyasova

    National Research Center for Hematology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 27, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2013

Study Completion

March 1, 2014

Last Updated

July 25, 2014

Results First Posted

July 18, 2014

Record last verified: 2014-07

Locations

RU(1)