Trial Outcomes & Findings for Rituximab for Prevention of Chronic GVHD (NCT NCT00379587)

NCT ID: NCT00379587

Last Updated: 2014-03-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 65 participants
• Primary outcome timeframe: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion
• Results posted on: 2014-03-19

Participant Flow

Participant milestones

Measure	Rituxan (Rituximab) 375mg/m\^2 IV at 3, 6, 9 and 12 months from transplantation
Overall Study STARTED	65
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Rituxan (Rituximab) 375mg/m\^2 IV at 3, 6, 9 and 12 months from transplantation
Overall Study Lost to Follow-up	2

Baseline Characteristics

Rituximab for Prevention of Chronic GVHD

Baseline characteristics by cohort

Measure	Rituxan (Rituximab) n=65 Participants 375mg/m\^2 IV at 3, 6, 9 and 12 months from transplantation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants

PRIMARY outcome

Timeframe: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion

Outcome measures

Measure	Rituxan (Rituximab) n=65 Participants 375mg/m\^2 IV at 3, 6, 9 and 12 months from transplantation
Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years Year One	38 percentage of participants
Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years Year Two	48 percentage of participants

SECONDARY outcome

Timeframe: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion

Outcome measures

Measure	Rituxan (Rituximab) n=65 Participants 375mg/m\^2 IV at 3, 6, 9 and 12 months from transplantation
Incidence of Grade 3 or Higher Infectious Complications Year One	11 percentage of participants
Incidence of Grade 3 or Higher Infectious Complications Year Two	15 percentage of participants

SECONDARY outcome

Timeframe: by 4 years after peripheral blood stem cell (PBSC) infusion

Percentage of participants with relapsed disease by year 4 post transplant.

Outcome measures

Measure	Rituxan (Rituximab) n=65 Participants 375mg/m\^2 IV at 3, 6, 9 and 12 months from transplantation
Incidence of Relapse or Progression of Disease	34 percentage of participants

SECONDARY outcome

Timeframe: by 18 months after peripheral blood stem (PBSC) infusion

White blood cell decrease, neutrophil cell count decrease, or platelet cell decrease considered possibly or probably related to therapy with rituximab.

Outcome measures

Measure	Rituxan (Rituximab) n=65 Participants 375mg/m\^2 IV at 3, 6, 9 and 12 months from transplantation
Incidence of Adverse Hematological Events	11 participants

Adverse Events

Rituxan (Rituximab)

Serious events: 6 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rituxan (Rituximab) n=65 participants at risk 375mg/m\^2 IV at 3, 6, 9 and 12 months from transplantation
Infections and infestations Septic Shock	1.5% 1/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.
Infections and infestations Pneumonia	3.1% 2/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.
Blood and lymphatic system disorders Febrile Neutropenia	1.5% 1/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.5% 1/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.
Respiratory, thoracic and mediastinal disorders Interstital Pneumonitis	1.5% 1/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.

Other adverse events

Measure	Rituxan (Rituximab) n=65 participants at risk 375mg/m\^2 IV at 3, 6, 9 and 12 months from transplantation
Blood and lymphatic system disorders Hemoglobin Decrease	6.2% 4/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.
Blood and lymphatic system disorders Neutrophil Decrease	10.8% 7/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.
Blood and lymphatic system disorders Platelet Decrease	6.2% 4/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.
General disorders Fatigue	7.7% 5/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.
Skin and subcutaneous tissue disorders Rash/Desquamation	6.2% 4/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.
Gastrointestinal disorders Mucositis	6.2% 4/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.
Blood and lymphatic system disorders Alkaline Phosphatase Increase	6.2% 4/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.
Blood and lymphatic system disorders Alanine Aminotransferase Increase	9.2% 6/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.
Blood and lymphatic system disorders Aspartate Aminotransferase Increase	9.2% 6/65 • Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once in that SOC.

Additional Information

Corey S. Cutler, MD, MPH

Dana-Farber Cancer Institute

Phone: 617-632-5946

Email: corey_cutler@dfci.harvard.edu

Results disclosure agreements

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