Trial Outcomes & Findings for Combination Chemotherapy With or Without Rituximab in Treating Participants With Stage III-IV Classic Hodgkin Lymphoma (NCT NCT00654732)

Last Updated: 2020-02-28

Results Overview

EFS will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis. Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

From the start of study treatment up to 3 years

Results posted on

2020-02-28

Participant Flow

Frontline advance stage hodgkin lymphoma

Participant milestones

Participant milestones
Measure	RABVD Rituximab Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine	ABVD Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine
Overall Study STARTED	26	32
Overall Study COMPLETED	22	26
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	RABVD Rituximab Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine	ABVD Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine
Overall Study Adverse Event	4	6

Baseline Characteristics

Combination Chemotherapy With or Without Rituximab in Treating Participants With Stage III-IV Classic Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RABVD n=26 Participants Rituximab Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine	ABVD n=32 Participants Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	22 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Asian	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Black or African American	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) White	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	26 Participants n=5 Participants	32 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment United States	NA participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of study treatment up to 3 years

Outcome measures

Outcome measures
Measure	RABVD n=22 Participants Experimental Arm Rituximab, Adriamycin, Bleomycin, Vinblastine, and Dacarbazine	ABVD n=26 Participants Control Arm (Adriamycin, Bleomycin, Vinblastine, and Dacarbazine)
Event-free Survival (EFS) Rate	17 Participants	20 Participants

Adverse Events

RABVD

Serious events: 13 serious events

Other events: 0 other events

Deaths: 5 deaths

ABVD

Serious events: 13 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	RABVD n=26 participants at risk Rituximab chemotherapy	ABVD n=32 participants at risk Chemotherapy only
Blood and lymphatic system disorders Neutropennia	50.0% 13/26 • 4 years and 6 months	40.6% 13/32 • 4 years and 6 months
Blood and lymphatic system disorders Anemia	3.8% 1/26 • 4 years and 6 months	6.2% 2/32 • 4 years and 6 months
Blood and lymphatic system disorders Thrombocytopenia	3.8% 1/26 • 4 years and 6 months	6.2% 2/32 • 4 years and 6 months
Immune system disorders Infection	15.4% 4/26 • 4 years and 6 months	3.1% 1/32 • 4 years and 6 months
Respiratory, thoracic and mediastinal disorders Respiratory Complicaton	0.00% 0/26 • 4 years and 6 months	6.2% 2/32 • 4 years and 6 months
Nervous system disorders Neuropathy	3.8% 1/26 • 4 years and 6 months	9.4% 3/32 • 4 years and 6 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hun Ju Lee, Associate Professor, Lymphoma/Myeloma

UT MD Anderson Cancer Center

Phone: 713 794-1829

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place