Trial Outcomes & Findings for Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma (NCT NCT00722865)
NCT ID: NCT00722865
Last Updated: 2017-10-18
Results Overview
Failure-free survival: the absence of relapse, non-relapse mortality or addition of another systemic therapy
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
2 years and median follow-up of 18 months
Results posted on
2017-10-18
Participant Flow
Participant milestones
| Measure |
Avastin (Bevacizumab)
single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Avastin (Bevacizumab)
n=25 Participants
single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.
|
|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
Stage of Cancer
Stage III
|
10 Participants
n=5 Participants
|
|
Stage of Cancer
Stage IV
|
15 Participants
n=5 Participants
|
|
Hemoglobin
<10.5 g/dL
|
7 Participants
n=5 Participants
|
|
Hemoglobin
>=10.5 g/dL
|
18 Participants
n=5 Participants
|
|
Leukocytosis
>15,000/uL
|
5 Participants
n=5 Participants
|
|
Leukocytosis
<=15,000/uL
|
20 Participants
n=5 Participants
|
|
Absolute lymphocyte count
<600/uL
|
4 Participants
n=5 Participants
|
|
Absolute lymphocyte count
>=600/uL
|
21 Participants
n=5 Participants
|
|
Albumin
<4.0 g/dL
|
17 Participants
n=5 Participants
|
|
Albumin
>=4.0 g/dL
|
8 Participants
n=5 Participants
|
|
B symptoms
Yes
|
15 Participants
n=5 Participants
|
|
B symptoms
No
|
10 Participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS)
0
|
1 Participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS)
1
|
5 Participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS)
2
|
5 Participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS)
3
|
4 Participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS)
4
|
7 Participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS)
5
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years and median follow-up of 18 monthsFailure-free survival: the absence of relapse, non-relapse mortality or addition of another systemic therapy
Outcome measures
| Measure |
Avastin (Bevacizumab)
n=25 Participants
single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.
|
|---|---|
|
Failure-free Survival
at 2 years
|
67 percentage of participants
Interval 50.0 to 84.0
|
|
Failure-free Survival
at median follow-up of 18 months
|
73 percentage of participants
Interval 57.0 to 88.0
|
SECONDARY outcome
Timeframe: 2 yearsOverall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (\<=1.5cm in greatest diameter) PR = \>=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT
Outcome measures
| Measure |
Avastin (Bevacizumab)
n=25 Participants
single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.
|
|---|---|
|
Overall Response Rate Using the Modified Cheson Criteria
|
96 percentage of participants
Interval 82.0 to 99.0
|
SECONDARY outcome
Timeframe: 2 years and medium follow-up of 18 monthsProgression-free survival: a patient lives with the disease but it does not get worse.
Outcome measures
| Measure |
Avastin (Bevacizumab)
n=25 Participants
single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.
|
|---|---|
|
Progression-free Survival
at 2 years
|
67 percentage of participants
Interval 50.0 to 84.0
|
|
Progression-free Survival
at median follow-up of 18 months
|
73 percentage of participants
Interval 57.0 to 88.0
|
SECONDARY outcome
Timeframe: 2 yearsOverall survival: patients are still alive.
Outcome measures
| Measure |
Avastin (Bevacizumab)
n=25 Participants
single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.
|
|---|---|
|
Overall Survival
|
25 Participants
|
SECONDARY outcome
Timeframe: 2 yearsToxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)
Outcome measures
| Measure |
Avastin (Bevacizumab)
n=25 Participants
single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.
|
|---|---|
|
Safety
Thrombocytopenia · Grade 1-2
|
3 Participants
|
|
Safety
Thrombocytopenia · Grade 3-4
|
0 Participants
|
|
Safety
Thrombocytopenia · Did not have any
|
22 Participants
|
|
Safety
Febrile neutropenia · Grade 1-2
|
0 Participants
|
|
Safety
Febrile neutropenia · Grade 3-4
|
4 Participants
|
|
Safety
Febrile neutropenia · Did not have any
|
21 Participants
|
|
Safety
Hypertension · Grade 1-2
|
2 Participants
|
|
Safety
Hypertension · Grade 3-4
|
1 Participants
|
|
Safety
Hypertension · Did not have any
|
22 Participants
|
|
Safety
Proteinuria · Grade 1-2
|
0 Participants
|
|
Safety
Proteinuria · Grade 3-4
|
0 Participants
|
|
Safety
Proteinuria · Did not have any
|
25 Participants
|
|
Safety
Pericardial effusion · Grade 1-2
|
1 Participants
|
|
Safety
Pericardial effusion · Grade 3-4
|
1 Participants
|
|
Safety
Pericardial effusion · Did not have any
|
23 Participants
|
|
Safety
Pleural effusion · Grade 1-2
|
1 Participants
|
|
Safety
Pleural effusion · Grade 3-4
|
0 Participants
|
|
Safety
Pleural effusion · Did not have any
|
24 Participants
|
|
Safety
Skin breakdown · Grade 1-2
|
0 Participants
|
|
Safety
Skin breakdown · Grade 3-4
|
1 Participants
|
|
Safety
Skin breakdown · Did not have any
|
24 Participants
|
|
Safety
Mucositis · Grade 1-2
|
4 Participants
|
|
Safety
Mucositis · Grade 3-4
|
0 Participants
|
|
Safety
Mucositis · Did not have any
|
21 Participants
|
|
Safety
Sensory neuropathy · Grade 1-2
|
8 Participants
|
|
Safety
Sensory neuropathy · Grade 3-4
|
1 Participants
|
|
Safety
Sensory neuropathy · Did not have any
|
16 Participants
|
|
Safety
Thrombosis/embolism · Grade 1-2
|
0 Participants
|
|
Safety
Thrombosis/embolism · Grade 3-4
|
2 Participants
|
|
Safety
Thrombosis/embolism · Did not have any
|
23 Participants
|
|
Safety
Renal failure · Grade 1-2
|
0 Participants
|
|
Safety
Renal failure · Grade 3-4
|
1 Participants
|
|
Safety
Renal failure · Did not have any
|
24 Participants
|
|
Safety
Fatigue · Grade 1-2
|
21 Participants
|
|
Safety
Fatigue · Grade 3-4
|
1 Participants
|
|
Safety
Fatigue · Did not have any
|
3 Participants
|
|
Safety
Anemia · Grade 1-2
|
19 Participants
|
|
Safety
Anemia · Grade 3-4
|
3 Participants
|
|
Safety
Anemia · Did not have any
|
3 Participants
|
|
Safety
Neutropenia · Grade 1-2
|
1 Participants
|
|
Safety
Neutropenia · Grade 3-4
|
22 Participants
|
|
Safety
Neutropenia · Did not have any
|
2 Participants
|
Adverse Events
Avastin (Bevacizumab)
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Avastin (Bevacizumab)
n=25 participants at risk
single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.
|
|---|---|
|
Nervous system disorders
Sensory Neuropathy
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Necrosis
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Pericardial Effusion
|
4.0%
1/25 • Number of events 1
|
Other adverse events
| Measure |
Avastin (Bevacizumab)
n=25 participants at risk
single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.
|
|---|---|
|
Gastrointestinal disorders
Ascites
|
100.0%
25/25 • Number of events 165
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
25/25 • Number of events 165
|
|
General disorders
Chills
|
100.0%
25/25 • Number of events 165
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
25/25 • Number of events 165
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
25/25 • Number of events 165
|
|
Blood and lymphatic system disorders
Leukocytosis
|
100.0%
25/25 • Number of events 165
|
|
General disorders
Head/headache
|
100.0%
25/25 • Number of events 165
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
100.0%
25/25 • Number of events 165
|
|
Gastrointestinal disorders
Jejunal fistula
|
100.0%
25/25 • Number of events 165
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
100.0%
25/25 • Number of events 165
|
|
Gastrointestinal disorders
Anal hemorrhage
|
56.0%
14/25 • Number of events 25
|
|
Nervous system disorders
Movements involuntary
|
36.0%
9/25 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial stricture
|
28.0%
7/25 • Number of events 11
|
|
General disorders
Abdomen- pain
|
20.0%
5/25 • Number of events 12
|
|
General disorders
Back- pain
|
20.0%
5/25 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.0%
4/25 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
16.0%
4/25 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
16.0%
4/25 • Number of events 7
|
|
Infections and infestations
Anorectal infection
|
16.0%
4/25 • Number of events 6
|
|
General disorders
Edema face
|
16.0%
4/25 • Number of events 5
|
|
Gastrointestinal disorders
Gastritis
|
16.0%
4/25 • Number of events 5
|
|
General disorders
Extremity-limb- pain
|
16.0%
4/25 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
12.0%
3/25 • Number of events 8
|
|
Blood and lymphatic system disorders
Nose- hemorrhage
|
12.0%
3/25 • Number of events 7
|
|
Cardiac disorders
Conduction disorder
|
12.0%
3/25 • Number of events 5
|
|
Cardiac disorders
Hypertension
|
12.0%
3/25 • Number of events 5
|
|
General disorders
Death neonatal
|
12.0%
3/25 • Number of events 5
|
|
Gastrointestinal disorders
Ileal obstruction
|
12.0%
3/25 • Number of events 5
|
|
Nervous system disorders
Edema cerebral
|
12.0%
3/25 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
12.0%
3/25 • Number of events 4
|
|
General disorders
Neck- pain
|
12.0%
3/25 • Number of events 3
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
8.0%
2/25 • Number of events 8
|
|
Metabolism and nutrition disorders
Alkalosis
|
8.0%
2/25 • Number of events 7
|
|
General disorders
Fatigue
|
8.0%
2/25 • Number of events 3
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
8.0%
2/25 • Number of events 3
|
|
General disorders
Joint, pain
|
8.0%
2/25 • Number of events 3
|
|
General disorders
Pain-other
|
8.0%
2/25 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
8.0%
2/25 • Number of events 3
|
|
Cardiac disorders
Myocarditis
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
8.0%
2/25 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.0%
2/25 • Number of events 2
|
|
Infections and infestations
Wound infection
|
8.0%
2/25 • Number of events 2
|
|
Infections and infestations
Infections and infestations - Other, specify
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Chest wall, pain
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Throat/pharynx/larynx- pain
|
8.0%
2/25 • Number of events 2
|
Additional Information
Jeremy Abramson, MD
Massachusetts General Hospital Cancer Center
Phone: 617-724-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place