Trial Outcomes & Findings for Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease (NCT NCT01042509)

NCT ID: NCT01042509

Last Updated: 2017-02-01

Results Overview

Overall response of participants to alemtuzumab and rituximab combination at day +30, +90 and +365 of follow-up

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 30, 90 and 365 days
• Results posted on: 2017-02-01

Participant Flow

Participant milestones

Measure	Patients With Chronic GVHD Patients with chronic GVHD after first-line therapy failure.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease

Baseline characteristics by cohort

Measure	Patients With Chronic GVHD n=15 Participants Patients with chronic GVHD after first-line therapy failure.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41 years STANDARD_DEVIATION 20 • n=5 Participants
Gender Female	5 Participants n=5 Participants
Gender Male	10 Participants n=5 Participants
Region of Enrollment Mexico	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 30, 90 and 365 days

Population: All consecutive patients were included in an intention to treat analysis to evaluate clinical response to alemtuzumab and rituximab combination.

Overall response of participants to alemtuzumab and rituximab combination at day +30, +90 and +365 of follow-up

Outcome measures

Measure	Treatment Group n=15 Participants This study had only one arm
Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006. Overall response at +30-day evaluation	100 percentage of participants
Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006. Overall response at +90-day evaluation	78 percentage of participants
Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006. Overall response at +365-day evaluation	80 percentage of participants

SECONDARY outcome

Timeframe: 365 days

Population: 15 consecutive patients were included for the analysis with periodical clinical evaluations to assess adverse effects.

Percentage of participants who experienced side effects

Outcome measures

Measure	Treatment Group n=15 Participants This study had only one arm
Side Effects	10 Participants

Adverse Events

Treatment Group

Serious events: 10 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Group n=15 participants at risk This study had only one arm
Infections and infestations pneumonia	6.7% 1/15 • Number of events 1 • 1 year
Infections and infestations infection	60.0% 9/15 • Number of events 9 • 1 year

Other adverse events

Measure	Treatment Group n=15 participants at risk This study had only one arm
Investigations pneumonia	46.7% 7/15 • Number of events 7 • 1 year

Additional Information

Dr. David Gomez-Almaguer

Hospital Universitario

Phone: 5281-83488510

Email: hematohu@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place