Trial Outcomes & Findings for Rituximab and ABVD for Hodgkin's Patients (NCT NCT00504504)

Last Updated: 2013-07-09

Results Overview

Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

85 participants

Primary outcome timeframe

Baseline to 5 Years or until disease progression

Results posted on

2013-07-09

Participant Flow

Recruitment Period: March 09, 2001 to August 29, 2007. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Of the 85 participants enrolled, three participants were excluded prior to assignment to groups as ineligible.

Participant milestones

Participant milestones
Measure	Rituximab + ABVD Chemotherapy Rituximab 375 mg/m\^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m\^2 IV, Bleomycin 10 U/m\^2 IV, Vinblastine 6 mg/m\^2 IV, DTIC 375 mg/m\^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
Overall Study STARTED	82
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rituximab and ABVD for Hodgkin's Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab + ABVD Chemotherapy n=82 Participants Rituximab 375 mg/m\^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m\^2 IV, Bleomycin 10 U/m\^2 IV, Vinblastine 6 mg/m\^2 IV, DTIC 375 mg/m\^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
Age Continuous	32 years n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 5 Years or until disease progression

Outcome measures

Outcome measures
Measure	Rituximab + ABVD Chemotherapy n=82 Participants Rituximab 375 mg/m\^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m\^2 IV, Bleomycin 10 U/m\^2 IV, Vinblastine 6 mg/m\^2 IV, DTIC 375 mg/m\^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD	83 percentage of participants

Adverse Events

Rituximab + ABVD Chemotherapy

Serious events: 40 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rituximab + ABVD Chemotherapy n=82 participants at risk Rituximab 375 mg/m\^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m\^2 IV, Bleomycin 10 U/m\^2 IV, Vinblastine 6 mg/m\^2 IV, DTIC 375 mg/m\^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
General disorders Fatigue	8.5% 7/82 • 6 years and 5 months
General disorders Pain	6.1% 5/82 • 6 years and 5 months
Gastrointestinal disorders Nausea	7.3% 6/82 • 6 years and 5 months
Gastrointestinal disorders Vomiting	1.2% 1/82 • 6 years and 5 months
Gastrointestinal disorders Constipation	1.2% 1/82 • 6 years and 5 months
Respiratory, thoracic and mediastinal disorders Dyspnea	1.2% 1/82 • 6 years and 5 months
Nervous system disorders Neuropathy	1.2% 1/82 • 6 years and 5 months
Blood and lymphatic system disorders Granuloctopenia	22.0% 18/82 • 6 years and 5 months

Other adverse events

Other adverse events
Measure	Rituximab + ABVD Chemotherapy n=82 participants at risk Rituximab 375 mg/m\^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m\^2 IV, Bleomycin 10 U/m\^2 IV, Vinblastine 6 mg/m\^2 IV, DTIC 375 mg/m\^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
General disorders Fatigue	39.0% 32/82 • 6 years and 5 months
General disorders Pain	34.1% 28/82 • 6 years and 5 months
General disorders Alopecia	42.7% 35/82 • 6 years and 5 months
Gastrointestinal disorders Nausea	54.9% 45/82 • 6 years and 5 months
Gastrointestinal disorders Vomiting	34.1% 28/82 • 6 years and 5 months
Gastrointestinal disorders Diarrhea	19.5% 16/82 • 6 years and 5 months
Gastrointestinal disorders Constipation	23.2% 19/82 • 6 years and 5 months
Respiratory, thoracic and mediastinal disorders Cough	19.5% 16/82 • 6 years and 5 months
Respiratory, thoracic and mediastinal disorders Dyspnea	18.3% 15/82 • 6 years and 5 months
Nervous system disorders Neuropathy	30.5% 25/82 • 6 years and 5 months
Blood and lymphatic system disorders Granuloctopenia	11.0% 9/82 • 6 years and 5 months

Additional Information

Anas Younes, MD / Professor

University of Texas (UT) MD Anderson Cancer

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place