Trial Outcomes & Findings for Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma (NCT NCT00369681)

NCT ID: NCT00369681

Last Updated: 2018-08-27

Results Overview

Number of relapses among participants who had tumors positive for Epstein-Barr virus (EBV).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: Up to 56 months
• Results posted on: 2018-08-27

Participant Flow

One subject withdrew consent prior to initiating the study.

Participant milestones

Measure	R-ABVD ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m\^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m\^2 Cycles 2, 4, and 6 Day 1.
Overall Study STARTED	50
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	R-ABVD ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m\^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m\^2 Cycles 2, 4, and 6 Day 1.
Overall Study Death	1

Baseline Characteristics

Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma

Baseline characteristics by cohort

Measure	R-ABVD n=49 Participants ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m\^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m\^2 Cycles 2, 4, and 6 Day 1.
Age, Continuous	33 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 56 months

Population: Only 4 participants had EBV(+) tumors.

Number of relapses among participants who had tumors positive for Epstein-Barr virus (EBV).

Outcome measures

Measure	R-ABVD n=4 Participants ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m\^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m\^2 Cycles 2, 4, and 6 Day 1.
Effect of Rituximab on EBV(+) Tumors	0 relapses

PRIMARY outcome

Timeframe: 3 years

Population: Only 21 participants had a detectable CD27(+) ALDH(+) clone prior to study intervention. The remaining participants either did not have such a clone or did not have a sample tested to look for a clone.

Number of relapses for participants who did and did not have re-emergence of clonal CD27(+) ALDH(+) B cells after completing study intervention.

Outcome measures

Measure	R-ABVD n=21 Participants ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m\^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m\^2 Cycles 2, 4, and 6 Day 1.
Relationship Between Marker Detection and Clinical Outcome No re-emergence of clone	0 relapses
Relationship Between Marker Detection and Clinical Outcome Re-emergence of clone	2 relapses

SECONDARY outcome

Timeframe: 3 years

Population: All evaluable participants.

Percentage of participants who did not experience death, relapse, or progression (worsening) of their lymphoma.

Outcome measures

Measure	R-ABVD n=49 Participants ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m\^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m\^2 Cycles 2, 4, and 6 Day 1.
Event-free Survival	83 percentage of participants Interval 68.0 to 92.0

SECONDARY outcome

Timeframe: 5 years

Population: Data pertaining to this outcome was not collected.

Outcome measures

Outcome data not reported

Adverse Events

R-ABVD

Serious events: 16 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	R-ABVD n=50 participants at risk ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m\^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m\^2 Cycles 2, 4, and 6 Day 1.
Blood and lymphatic system disorders Febrile neutropenia	14.0% 7/50 • Number of events 7 • Adverse events were tracked monthly for up to six months. Only the following adverse events were collected for this study: all grade 3-5 toxicities; any previously-undescribed toxicity potentially attributable to the addition of the rituximab to the ABVD regimen, regardless of grade; any toxicity associated with infusion of rituximab, regardless of grade.
Infections and infestations Non-neutropenic infection	18.0% 9/50 • Number of events 9 • Adverse events were tracked monthly for up to six months. Only the following adverse events were collected for this study: all grade 3-5 toxicities; any previously-undescribed toxicity potentially attributable to the addition of the rituximab to the ABVD regimen, regardless of grade; any toxicity associated with infusion of rituximab, regardless of grade.
Vascular disorders Thrombosis	8.0% 4/50 • Number of events 4 • Adverse events were tracked monthly for up to six months. Only the following adverse events were collected for this study: all grade 3-5 toxicities; any previously-undescribed toxicity potentially attributable to the addition of the rituximab to the ABVD regimen, regardless of grade; any toxicity associated with infusion of rituximab, regardless of grade.
Respiratory, thoracic and mediastinal disorders Pulmonary toxicity	6.0% 3/50 • Number of events 3 • Adverse events were tracked monthly for up to six months. Only the following adverse events were collected for this study: all grade 3-5 toxicities; any previously-undescribed toxicity potentially attributable to the addition of the rituximab to the ABVD regimen, regardless of grade; any toxicity associated with infusion of rituximab, regardless of grade.
Investigations Other, not specified	8.0% 4/50 • Number of events 4 • Adverse events were tracked monthly for up to six months. Only the following adverse events were collected for this study: all grade 3-5 toxicities; any previously-undescribed toxicity potentially attributable to the addition of the rituximab to the ABVD regimen, regardless of grade; any toxicity associated with infusion of rituximab, regardless of grade.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yvette Kasamon

Johns Hopkins University

Phone: 410-955-8839

Email: ykasamon@jhmi.edu

Results disclosure agreements

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