Trial Outcomes & Findings for Brentuximab Vedotin Plus AD in Non-bulky Limited Stage Hodgkin Lymphoma (NCT NCT02505269)

Last Updated: 2020-08-24

Results Overview

The number of patients that achieved a complete response (CR) to therapy as assessed by the revised International Working Group Criteria. Complete response: * Lymph nodes and extralymphatic sites: Score 1, 2, or 3 with or without a residual mass on 5-point (Daeuville) scale * Bone Marrow: No evidence of FDG-avi disease * No new lesions Deauville Criteria for PET scan Interpretation in Lymphoma Five-point scale: 1. No Uptake 2. Uptake ≤ mediastinum 3. Uptake \>mediastinum but ≤ liver 4. Uptake moderately increased compared to liver at any site 5. Uptake markedly increased compared to the liver at any site or/and new sites of disease

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

4-6 months

Results posted on

2020-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	Brentuximab Vedotin The following procedures will take place during study visits beginning after the screening procedures: \- Participants will receive combination therapy: * Brentuximab Vedotin intravenously on predetermined days per cycle * Adriamycin intravenously on predetermined days per cycle * Dacarbazine intravenously on predetermined days per cycle Brentuximab Vedotin Adriamycin Dacarbazine
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brentuximab Vedotin n=34 Participants The following procedures will take place during study visits beginning after the screening procedures: \- Participants will receive combination therapy: * Brentuximab Vedotin intravenously on predetermined days per cycle * Adriamycin intravenously on predetermined days per cycle * Dacarbazine intravenously on predetermined days per cycle Brentuximab Vedotin Adriamycin Dacarbazine
Age, Continuous	36 years n=34 Participants
Sex: Female, Male Female	23 Participants n=34 Participants
Sex: Female, Male Male	11 Participants n=34 Participants
Region of Enrollment United States	34 Participants n=34 Participants

PRIMARY outcome

Timeframe: 4-6 months

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=34 Participants The following procedures will take place during study visits beginning after the screening procedures: \- Participants will receive combination therapy: * Brentuximab Vedotin intravenously on predetermined days per cycle * Adriamycin intravenously on predetermined days per cycle * Dacarbazine intravenously on predetermined days per cycle Brentuximab Vedotin Adriamycin Dacarbazine
Complete Response Rate	34 Participants

SECONDARY outcome

Timeframe: 4-6 months

The number of patients that achieved a complete Metabolic Response (CR) or Partial Metabolic Response (PR) to therapy as assessed by the revised International Working Group Criteria. Complete Metabolic Response: Lymph nodes and extralymphatic sites: Score 1, 2, or 3 with or without a residual mass on 5-point (Daeuville) scale Bone Marrow: No evidence of FDG-avi disease No new lesions Partial Metabolic Response: \>Lymph nodes and extralymphatic sites: Score 4, 5 with reduced uptake compared with baseline and residual mass(es) of any size. Deauville Criteria for PET scan Interpretation in Lymphoma Five-point scale: 1. No Uptake 2. Uptake ≤ mediastinum 3. Uptake \>mediastinum but ≤ liver 4. Uptake moderately increased compared to liver at any site 5. Uptake markedly increased compared to the liver at any site or/and new sites of disease

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=34 Participants The following procedures will take place during study visits beginning after the screening procedures: \- Participants will receive combination therapy: * Brentuximab Vedotin intravenously on predetermined days per cycle * Adriamycin intravenously on predetermined days per cycle * Dacarbazine intravenously on predetermined days per cycle Brentuximab Vedotin Adriamycin Dacarbazine
Overall Response Rate	34 Participants

SECONDARY outcome

Timeframe: 4-6 months

The number of patients that experienced grade III and grade IV adverse events that were deemed to be possibly, probably, or definitely related to study treatment. Adverse events were assessed using Common Toxicology Criteria for Adverse Events (CTCAE v4.0) criteria.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=34 Participants The following procedures will take place during study visits beginning after the screening procedures: \- Participants will receive combination therapy: * Brentuximab Vedotin intravenously on predetermined days per cycle * Adriamycin intravenously on predetermined days per cycle * Dacarbazine intravenously on predetermined days per cycle Brentuximab Vedotin Adriamycin Dacarbazine
Number of Patients With Grade III and IV Adverse Events Grade III Adverse Events	4 Participants
Number of Patients With Grade III and IV Adverse Events Grade IV Adverse Events	0 Participants

Adverse Events

Brentuximab Vedotin

Serious events: 5 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Brentuximab Vedotin n=34 participants at risk The following procedures will take place during study visits beginning after the screening procedures: \- Participants will receive combination therapy: * Brentuximab Vedotin intravenously on predetermined days per cycle * Adriamycin intravenously on predetermined days per cycle * Dacarbazine intravenously on predetermined days per cycle Brentuximab Vedotin Adriamycin Dacarbazine
Gastrointestinal disorders Colitis	2.9% 1/34 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 1/34 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Infections and infestations Upper respiratory infection	2.9% 1/34 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Nausea	2.9% 1/34 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Vomiting	2.9% 1/34 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Diarrhea	2.9% 1/34 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Vascular disorders Thromboembolic event	2.9% 1/34 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)

Other adverse events

Other adverse events
Measure	Brentuximab Vedotin n=34 participants at risk The following procedures will take place during study visits beginning after the screening procedures: \- Participants will receive combination therapy: * Brentuximab Vedotin intravenously on predetermined days per cycle * Adriamycin intravenously on predetermined days per cycle * Dacarbazine intravenously on predetermined days per cycle Brentuximab Vedotin Adriamycin Dacarbazine
Gastrointestinal disorders Abdominal pain	14.7% 5/34 • Number of events 6 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Investigations Alanine aminotransferase increased	20.6% 7/34 • Number of events 9 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Skin and subcutaneous tissue disorders Alopecia	35.3% 12/34 • Number of events 14 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Blood and lymphatic system disorders Anemia	14.7% 5/34 • Number of events 6 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Metabolism and nutrition disorders Anorexia	17.6% 6/34 • Number of events 7 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Psychiatric disorders Anxiety	26.5% 9/34 • Number of events 10 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Musculoskeletal and connective tissue disorders Arthralgia	11.8% 4/34 • Number of events 7 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Investigations Aspartate aminotransferase increased	20.6% 7/34 • Number of events 9 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Musculoskeletal and connective tissue disorders Back pain	5.9% 2/34 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Bloating	5.9% 2/34 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Eye disorders Blurred vision	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Reproductive system and breast disorders Breast pain	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Nervous system disorders Concentration impairment	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Constipation	52.9% 18/34 • Number of events 24 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Respiratory, thoracic and mediastinal disorders Cough	20.6% 7/34 • Number of events 7 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Diarrhea	11.8% 4/34 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Eye disorders Dry eye	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Dry mouth	8.8% 3/34 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Skin and subcutaneous tissue disorders Dry skin	8.8% 3/34 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Nervous system disorders Dysgeusia	11.8% 4/34 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Dyspepsia	17.6% 6/34 • Number of events 9 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Respiratory, thoracic and mediastinal disorders Dyspnea	11.8% 4/34 • Number of events 7 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Endocrine disorders Endocrine disorders - Other, specify	8.8% 3/34 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Skin and subcutaneous tissue disorders Erythema multiforme	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
General disorders Fatigue	61.8% 21/34 • Number of events 29 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
General disorders Fever	8.8% 3/34 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Vascular disorders Flushing	8.8% 3/34 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Gastroesophageal reflux disease	14.7% 5/34 • Number of events 6 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	14.7% 5/34 • Number of events 5 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
General disorders General disorders and administration site conditions - Other, specify	5.9% 2/34 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Gingival pain	5.9% 2/34 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Nervous system disorders Headache	26.5% 9/34 • Number of events 13 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Respiratory, thoracic and mediastinal disorders Hiccups	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Vascular disorders Hot flashes	11.8% 4/34 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Metabolism and nutrition disorders Hyperglycemia	11.8% 4/34 • Number of events 7 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Psychiatric disorders Insomnia	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Investigations Lymphocyte count decreased	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Mucositis oral	17.6% 6/34 • Number of events 8 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Musculoskeletal and connective tissue disorders Myalgia	11.8% 4/34 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Respiratory, thoracic and mediastinal disorders Nasal congestion	20.6% 7/34 • Number of events 7 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Nausea	79.4% 27/34 • Number of events 39 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
General disorders Neck edema	5.9% 2/34 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Investigations Neutrophil count decreased	23.5% 8/34 • Number of events 11 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
General disorders Non-cardiac chest pain	11.8% 4/34 • Number of events 5 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Nervous system disorders Paresthesia	14.7% 5/34 • Number of events 6 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Nervous system disorders Peripheral sensory neuropathy	61.8% 21/34 • Number of events 29 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Skin and subcutaneous tissue disorders Pruritus	23.5% 8/34 • Number of events 8 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Skin and subcutaneous tissue disorders Rash acneiform	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Skin and subcutaneous tissue disorders Rash maculo-papular	23.5% 8/34 • Number of events 16 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Skin and subcutaneous tissue disorders Scalp pain	8.8% 3/34 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Skin and subcutaneous tissue disorders Skin ulceration	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Respiratory, thoracic and mediastinal disorders Sore throat	17.6% 6/34 • Number of events 7 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Ear and labyrinth disorders Tinnitus	5.9% 2/34 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Infections and infestations Upper respiratory infection	11.8% 4/34 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Gastrointestinal disorders Vomiting	14.7% 5/34 • Number of events 5 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)
Investigations White blood cell decreased	17.6% 6/34 • Number of events 10 • From the start of treatment until 30 days after the end of treatment (up to approximately 5 months)

Additional Information

Dr. Jeremy Abramson

Massachusetts General Hospital

Phone: 617-724-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place