Trial Outcomes & Findings for Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL) (NCT NCT05328102)
NCT ID: NCT05328102
Last Updated: 2024-04-30
Results Overview
An adverse event (AE) was any untoward medical occurrence in a study participant. The AE did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug. AEs may have included the onset of new illness and the exacerbation of preexisting conditions. TEAEs were defined as events with onset dates on or after the start of study treatment or events that were present before the first infusion of study treatment and subsequently worsened in severity. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Results posted on
2024-04-30
Participant Flow
The study planned to enroll participants at 11 sites (1 in the United States, 7 in France, 2 in Spain, and 1 in South Korea). However, due to early study termination only 3 participants were enrolled and dosed at a single site in the United States.
The study was planned to be performed sequentially, with Part 1A (Safety run-in, with a lower plamotamab dose), Part 1B (Safety run-in, with the target plamotamab dose) and Part 2 (Open-Label, randomized). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
Participant milestones
| Measure |
Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide
Plamotamab was administered at a lower dose in addition to tafasitamab (12 milligrams \[mg\]/kilograms \[kg\] intravenously) plus lenalidomide (25 mg orally).
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL)
Baseline characteristics by cohort
| Measure |
Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide
n=3 Participants
Plamotamab was administered at a lower dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25 mg orally).
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|---|---|
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Age, Customized
>=18 years
|
3 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)Population: Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
An adverse event (AE) was any untoward medical occurrence in a study participant. The AE did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug. AEs may have included the onset of new illness and the exacerbation of preexisting conditions. TEAEs were defined as events with onset dates on or after the start of study treatment or events that were present before the first infusion of study treatment and subsequently worsened in severity. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide
n=3 Participants
Plamotamab was administered at a lower dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25 mg orally).
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|---|---|
|
Part 1 A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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3 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)Population: Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
Cytokine release syndrome was defined as "a supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T cells and/or other immune effector cells". A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide
n=3 Participants
Plamotamab was administered at a lower dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25 mg orally).
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|---|---|
|
Part 1 A: Number of Participants With Cytokine Release Syndrome
|
2 Participants
|
Adverse Events
Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide
n=3 participants at risk
Plamotamab was administered at a lower dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25 mg orally).
|
|---|---|
|
Immune system disorders
Cytokine release syndrome
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Infections and infestations
Pneumonia aspiration
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
Other adverse events
| Measure |
Part 1A: Plamotamab (Lower Dose), Tafasitamab, and Lenalidomide
n=3 participants at risk
Plamotamab was administered at a lower dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25 mg orally).
|
|---|---|
|
Immune system disorders
Cytokine release syndrome
|
66.7%
2/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
General disorders
Fatigue
|
66.7%
2/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Renal and urinary disorders
Hydronephrosis
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
General disorders
Asthenia
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
66.7%
2/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
66.7%
2/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
66.7%
2/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Infections and infestations
Urinary tract infection
|
66.7%
2/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Nervous system disorders
Metabolic encephalopathy
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Gastrointestinal disorders
Abdominal hernia
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
|
Vascular disorders
Embolism
|
33.3%
1/3 • From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)
Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place