A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation

• Sponsor: National Hematological Society, Russia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01519648
• Collaborator: (none)
• Enrollment: 808
• Location: 1
• Duration (Months): 26
• Patients Per Site Per Month: 31.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Fungal Infections

Detailed Description

This multi-center observational study of IFI in high risk hematological patients, the study will investigate the epidemiology of IFI, describe antifungal strategy, proportion of antifungal prophylaxis, empiric therapy, pre-emptive therapy and targeted therapy in at-risk patients.

Study Design

• Study Type: Observational
• Actual Enrollment: 808 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Acute leukemia patients Patients with de novo or relapsed acute myeloid and lymphoid leukemia
Allo- or auto- transplant recipients

Outcome Measures

Primary Outcome Measures

1. The Rate of Invasive Fungal Infections [6 month]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy

• All newly allogeneic or autologous transplant recipients during the study period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Hematological Society	Moscow		Russian Federation	119021

Sponsors and Collaborators

• National Hematological Society, Russia

Investigators

• Principal Investigator: Galina A Klyasova, National Research Center for Hematology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Hematological Society, Russia
• ClinicalTrials.gov Identifier: NCT01519648
• Other Study ID Numbers: RIFI
• First Posted: Jan 27, 2012
• Last Update Posted: Jul 25, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by National Hematological Society, Russia: Invasive fungal infection; Acute leukemia (AL); Hematopoietic stem cell transplantation; Antifungal stewardship; Neutropenia; Hematological malignancies
• Additional relevant MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections; Leukemia

Study Results

Participant Flow

Arm/Group Title	Acute Leukemia Patients	Allo- or Auto- Transplant Recipients
Arm/Group Description	Patients with de novo or relapsed acute myeloid and lymphoid leukemia
Period Title: Overall Study
STARTED	502	306
COMPLETED	502	306
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Acute Leukemia Patients	Allo- or Auto- Transplant Recipients	Total
Arm/Group Description	Patients with de novo or relapsed acute myeloid and lymphoid leukemia	Total of all reporting groups
Overall Participants	502	306	808
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	42 (1-79)	37 (1-66)	40 (1-79)
Age (Count of Participants)
<=18 years	69 13.7%	55 18%	124 15.3%
Between 18 and 65 years	389 77.5%	250 81.7%	639 79.1%
>=65 years	44 8.8%	1 0.3%	45 5.6%
Sex: Female, Male (Count of Participants)
Female	261 52%	150 49%	411 50.9%
Male	241 48%	156 51%	397 49.1%
Region of Enrollment (participants) [Number]
Russian Federation	502 100%	306 100%	808 100%

Outcome Measures

1. Primary Outcome

Title	The Rate of Invasive Fungal Infections
Description	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.
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute Leukemia Patients	Allo- or Auto- Transplant Recipients
Arm/Group Description	Patients with de novo or relapsed acute myeloid and lymphoid leukemia	Allo- or auto- transplant recipients
Measure Participants	502	306
Number [participants]	77 15.3%	27 8.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acute Leukemia Patients, Allo- or Auto- Transplant Recipients
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.872
	Confidence Interval	(2-Sided) 95%; 1.178 to 2.977
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.237
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	The study was observational and the adverse events were not evaluated
Arm/Group Title	Acute Leukemia Patients		Allo- or Auto- Transplant Recipients
Arm/Group Description	Patients with de novo or relapsed acute myeloid and lymphoid leukemia
All Cause Mortality
	Acute Leukemia Patients		Allo- or Auto- Transplant Recipients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Acute Leukemia Patients		Allo- or Auto- Transplant Recipients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Acute Leukemia Patients		Allo- or Auto- Transplant Recipients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.