Trial Outcomes & Findings for A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation (NCT NCT01519648)

NCT ID: NCT01519648

Last Updated: 2014-07-25

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

808 participants

Primary outcome timeframe

6 month

Results posted on

2014-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	Acute Leukemia Patients Patients with de novo or relapsed acute myeloid and lymphoid leukemia	Allo- or Auto- Transplant Recipients
Overall Study STARTED	502	306
Overall Study COMPLETED	502	306
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acute Leukemia Patients n=502 Participants Patients with de novo or relapsed acute myeloid and lymphoid leukemia	Allo- or Auto- Transplant Recipients n=306 Participants	Total n=808 Participants Total of all reporting groups
Age, Continuous	42 years FULL_RANGE 1-79 • n=5 Participants	37 years FULL_RANGE 1-66 • n=7 Participants	40 years FULL_RANGE 1-79 • n=5 Participants
Age, Categorical <=18 years	69 Participants n=5 Participants	55 Participants n=7 Participants	124 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	389 Participants n=5 Participants	250 Participants n=7 Participants	639 Participants n=5 Participants
Age, Categorical >=65 years	44 Participants n=5 Participants	1 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Female	261 Participants n=5 Participants	150 Participants n=7 Participants	411 Participants n=5 Participants
Sex: Female, Male Male	241 Participants n=5 Participants	156 Participants n=7 Participants	397 Participants n=5 Participants
Region of Enrollment Russian Federation	502 participants n=5 Participants	306 participants n=7 Participants	808 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 month

Outcome measures

Outcome measures
Measure	Acute Leukemia Patients n=502 Participants Patients with de novo or relapsed acute myeloid and lymphoid leukemia	Allo- or Auto- Transplant Recipients n=306 Participants Allo- or auto- transplant recipients
The Rate of Invasive Fungal Infections	77 participants	27 participants

Adverse Events

Acute Leukemia Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Allo- or Auto- Transplant Recipients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Galina A Klyasova

National Hematological Society

Phone: +7(495)6125181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place