Trial Outcomes & Findings for Belantamab Mafodotin In Plasmablastic Lymphoma & ALK+ Large B-Cell Lymphoma (NCT NCT04676360)
NCT ID: NCT04676360
Last Updated: 2026-03-13
Results Overview
Proportion of patients who achieved partial response or complete response per 2014 Lugano criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Measured up to 2 years
Results posted on
2026-03-13
Participant Flow
Participant milestones
| Measure |
(BELANTAMAB MAFODOTIN
* Belantamab mafodotin will be administered intravenously on day 1 of a 21-day cycle.
* Treatment is intended to be administered on an outpatient basis.
Belantamab Mafodotin: Belantamab mafodotin will be administered intravenously at calculated dose on day 1 of each 21-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Belantamab Mafodotin In Plasmablastic Lymphoma & ALK+ Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
(BELANTAMAB MAFODOTIN
n=10 Participants
* Belantamab mafodotin will be administered intravenously on day 1 of a 21-day cycle.
* Treatment is intended to be administered on an outpatient basis.
Belantamab Mafodotin: Belantamab mafodotin will be administered intravenously at calculated dose on day 1 of each 21-day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Measured up to 2 yearsProportion of patients who achieved partial response or complete response per 2014 Lugano criteria.
Outcome measures
| Measure |
(BELANTAMAB MAFODOTIN
n=10 Participants
* Belantamab mafodotin will be administered intravenously on day 1 of a 21-day cycle.
* Treatment is intended to be administered on an outpatient basis.
Belantamab Mafodotin: Belantamab mafodotin will be administered intravenously at calculated dose on day 1 of each 21-day cycle.
|
|---|---|
|
Overall Response Rate
Complete response
|
0 Participants
|
|
Overall Response Rate
Partial response
|
0 Participants
|
|
Overall Response Rate
Stable disease
|
0 Participants
|
|
Overall Response Rate
Progressive disease
|
10 Participants
|
SECONDARY outcome
Timeframe: Measured up to 2 yearsProportion of patients who achieved complete response per 2014 Lugano criteria
Outcome measures
| Measure |
(BELANTAMAB MAFODOTIN
n=10 Participants
* Belantamab mafodotin will be administered intravenously on day 1 of a 21-day cycle.
* Treatment is intended to be administered on an outpatient basis.
Belantamab Mafodotin: Belantamab mafodotin will be administered intravenously at calculated dose on day 1 of each 21-day cycle.
|
|---|---|
|
Complete Response Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
(BELANTAMAB MAFODOTIN
n=10 Participants
* Belantamab mafodotin will be administered intravenously on day 1 of a 21-day cycle.
* Treatment is intended to be administered on an outpatient basis.
Belantamab Mafodotin: Belantamab mafodotin will be administered intravenously at calculated dose on day 1 of each 21-day cycle.
|
|---|---|
|
Progression Free Survival
|
1.38 months
Interval 0.69 to 1.41
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
(BELANTAMAB MAFODOTIN
n=10 Participants
* Belantamab mafodotin will be administered intravenously on day 1 of a 21-day cycle.
* Treatment is intended to be administered on an outpatient basis.
Belantamab Mafodotin: Belantamab mafodotin will be administered intravenously at calculated dose on day 1 of each 21-day cycle.
|
|---|---|
|
Overall Survival
|
3.49 months
Interval 1.12 to 7.82
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
(BELANTAMAB MAFODOTIN
n=10 Participants
* Belantamab mafodotin will be administered intravenously on day 1 of a 21-day cycle.
* Treatment is intended to be administered on an outpatient basis.
Belantamab Mafodotin: Belantamab mafodotin will be administered intravenously at calculated dose on day 1 of each 21-day cycle.
|
|---|---|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v5.0
|
10 Participants
|
Adverse Events
(BELANTAMAB MAFODOTIN
Serious events: 6 serious events
Other events: 10 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
(BELANTAMAB MAFODOTIN
n=10 participants at risk
* Belantamab mafodotin will be administered intravenously on day 1 of a 21-day cycle.
* Treatment is intended to be administered on an outpatient basis.
Belantamab Mafodotin: Belantamab mafodotin will be administered intravenously at calculated dose on day 1 of each 21-day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Tumor lysis syndrome
|
10.0%
1/10 • 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
10.0%
1/10 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
10.0%
1/10 • 2 years
|
|
General disorders
Disease progression
|
10.0%
1/10 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
10.0%
1/10 • 2 years
|
Other adverse events
| Measure |
(BELANTAMAB MAFODOTIN
n=10 participants at risk
* Belantamab mafodotin will be administered intravenously on day 1 of a 21-day cycle.
* Treatment is intended to be administered on an outpatient basis.
Belantamab Mafodotin: Belantamab mafodotin will be administered intravenously at calculated dose on day 1 of each 21-day cycle.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
2/10 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
20.0%
2/10 • 2 years
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
2/10 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
20.0%
2/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
20.0%
2/10 • 2 years
|
|
Infections and infestations
Thrush
|
20.0%
2/10 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
2/10 • 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • 2 years
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • 2 years
|
|
Infections and infestations
Bacteremia
|
10.0%
1/10 • 2 years
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Blurred vision
|
10.0%
1/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
2/10 • 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
10.0%
1/10 • 2 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
10.0%
1/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.0%
1/10 • 2 years
|
|
General disorders
Chills
|
10.0%
1/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • 2 years
|
|
General disorders
Fatigue
|
80.0%
8/10 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • 2 years
|
|
Investigations
Platelet count decreased
|
50.0%
5/10 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
5/10 • 2 years
|
|
General disorders
Edema limbs
|
40.0%
4/10 • 2 years
|
|
General disorders
Fever
|
50.0%
5/10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
40.0%
4/10 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
4/10 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
30.0%
3/10 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
30.0%
3/10 • 2 years
|
|
Eye disorders
Dry eye
|
30.0%
3/10 • 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
40.0%
4/10 • 2 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
30.0%
3/10 • 2 years
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • 2 years
|
|
Investigations
Neutrophil count decreased
|
30.0%
3/10 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
2/10 • 2 years
|
|
Psychiatric disorders
Anxiety
|
20.0%
2/10 • 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
20.0%
2/10 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • 2 years
|
|
Investigations
Creatinine increased
|
30.0%
3/10 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • 2 years
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
10.0%
1/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
1/10 • 2 years
|
|
Investigations
Fibrinogen decreased
|
10.0%
1/10 • 2 years
|
|
Infections and infestations
Fungemia
|
10.0%
1/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
1/10 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
10.0%
1/10 • 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.0%
1/10 • 2 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
10.0%
1/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
1/10 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10 • 2 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
10.0%
1/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
1/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.0%
1/10 • 2 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
10.0%
1/10 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
10.0%
1/10 • 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
10.0%
1/10 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
1/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
10.0%
1/10 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • 2 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
10.0%
1/10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • 2 years
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
1/10 • 2 years
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • 2 years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
10.0%
1/10 • 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
1/10 • 2 years
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10 • 2 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
10.0%
1/10 • 2 years
|
|
Investigations
White blood cell decreased
|
10.0%
1/10 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.0%
1/10 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
1/10 • 2 years
|
|
General disorders
Gait disturbance
|
10.0%
1/10 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place