Trial Outcomes & Findings for Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease (NCT NCT01404936)

Results Overview

Complete Response (CR): Disappearance of all clinical evidence of active tumors for a minimum of 8 weeks. Partial Response (PR): 50% or greater decrease in sum of products all measured lesions persisting for at least 4 weeks. No Change: Steady state or change of +/- 25% of tumor size and no progression for minimum of 8 weeks with no appearance of new lesions. Progressive Disease: \> 25 % increase in size of any measurable lesion or appearance of significant new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

After 6 courses (3 months)

Results posted on

2013-02-01

Participant Flow

Recruitment Period: July 25, 1996 through March 3, 2000. All participants were recruited at UT MD Anderson Cancer Center.

Of the 35 participants registered, five (5) were excluded from the trial.

Participant milestones

Participant milestones
Measure	Interferon-2A + Chemotherapy Interferon-2A 4 (x106 IU/m\^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m\^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interferon-2A + Chemotherapy n=30 Participants Interferon-2A 4 (x106 IU/m\^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m\^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
Age Continuous	30 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: After 6 courses (3 months)

Population: Two patients did not complete therapy; however, they were included in the intent-to-treat analysis. One patient was censored at the last follow-up date since no events had occurred.

Complete Response (CR): Disappearance of all clinical evidence of active tumors for a minimum of 8 weeks. Partial Response (PR): 50% or greater decrease in sum of products all measured lesions persisting for at least 4 weeks. No Change: Steady state or change of +/- 25% of tumor size and no progression for minimum of 8 weeks with no appearance of new lesions. Progressive Disease: \> 25 % increase in size of any measurable lesion or appearance of significant new lesions.

Outcome measures

Outcome measures
Measure	Interferon-2A + Chemotherapy n=30 Participants Interferon-2A 4 (x106 IU/m\^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m\^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
Participants' Response Complete Response	23 participants
Participants' Response Uncomfirmed Complete Response	2 participants
Participants' Response Partial Response	3 participants
Participants' Response Progressive Disease	1 participants

Adverse Events

Interferon-2A + Chemotherapy

Serious events: 3 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Interferon-2A + Chemotherapy n=30 participants at risk Interferon-2A 4 (x106 IU/m\^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m\^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
Blood and lymphatic system disorders Cytopenia	3.3% 1/30 • 3 years and 4 months
Hepatobiliary disorders Hepatotoxicity	3.3% 1/30 • 3 years and 4 months
Respiratory, thoracic and mediastinal disorders Pulmonary Toxicity	3.3% 1/30 • 3 years and 4 months

Other adverse events

Other adverse events
Measure	Interferon-2A + Chemotherapy n=30 participants at risk Interferon-2A 4 (x106 IU/m\^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m\^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
General disorders Asthenia	6.7% 2/30 • 3 years and 4 months
Investigations Fever	33.3% 10/30 • 3 years and 4 months
Gastrointestinal disorders Nausea	66.7% 20/30 • 3 years and 4 months
Psychiatric disorders Psychiatric Disorders	6.7% 2/30 • 3 years and 4 months

Additional Information

Anas Younes, MD / Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place