Trial Outcomes & Findings for A Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory PMLBCL (NCT NCT02423291)
NCT ID: NCT02423291
Last Updated: 2017-06-26
Results Overview
The antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma was determined using Cheson BD, Pfistner B, Juweid ME, et al. "Revised response criteria for malignant lymphoma". J Clin Oncol. 2007 Feb 10;25(5):579-586.Treatment response was assessed by dedicated spiral CT scan of neck, chest, neck, abdomen, and pelvis and PET scans performed at protocol-specified time points. Clinical response of progressive disease (PD), stable disease (SD), partial remission (PR), or complete remission (CR) will be determined at each assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
42 months
Results posted on
2017-06-26
Participant Flow
Participant milestones
| Measure |
Vial for IV Infusion
This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.
Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.
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|---|---|
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Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
0
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|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Vial for IV Infusion
This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.
Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.
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|---|---|
|
Overall Study
Lack of Efficacy
|
14
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vial for IV Infusion
n=15 Participants
This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.
Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=15 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 18.63 • n=15 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=15 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: 42 monthsPopulation: Trial was closed due to drug inefficacy on 14/Jul/2016 (last enrollment on 30/Jun/2015). Details in the Outcome Measure Data Table.
The antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma was determined using Cheson BD, Pfistner B, Juweid ME, et al. "Revised response criteria for malignant lymphoma". J Clin Oncol. 2007 Feb 10;25(5):579-586.Treatment response was assessed by dedicated spiral CT scan of neck, chest, neck, abdomen, and pelvis and PET scans performed at protocol-specified time points. Clinical response of progressive disease (PD), stable disease (SD), partial remission (PR), or complete remission (CR) will be determined at each assessment.
Outcome measures
| Measure |
Vial for IV Infusion
n=15 Participants
This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.
Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.
|
|---|---|
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Overall Objective Response Rate in Patients With Relapsed or Refractory PMLBCL
Quick PD
|
11 Participants
|
|
Overall Objective Response Rate in Patients With Relapsed or Refractory PMLBCL
PD after 1 cycle
|
1 Participants
|
|
Overall Objective Response Rate in Patients With Relapsed or Refractory PMLBCL
PD after 2 cycle
|
1 Participants
|
|
Overall Objective Response Rate in Patients With Relapsed or Refractory PMLBCL
PR
|
1 Participants
|
|
Overall Objective Response Rate in Patients With Relapsed or Refractory PMLBCL
SAE not related to drug
|
1 Participants
|
Adverse Events
Vial for IV Infusion
Serious events: 1 serious events
Other events: 15 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Vial for IV Infusion
n=15 participants at risk
This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.
Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.
|
|---|---|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected durig all Study Duration (3 years, 10 months).
We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
|
Other adverse events
| Measure |
Vial for IV Infusion
n=15 participants at risk
This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.
Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.
|
|---|---|
|
Gastrointestinal disorders
Intestinal perforation
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected durig all Study Duration (3 years, 10 months).
We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
|
|
Nervous system disorders
Peripheral neuropathy (NEC)
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected durig all Study Duration (3 years, 10 months).
We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected durig all Study Duration (3 years, 10 months).
We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected durig all Study Duration (3 years, 10 months).
We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected durig all Study Duration (3 years, 10 months).
We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected durig all Study Duration (3 years, 10 months).
We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected durig all Study Duration (3 years, 10 months).
We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected durig all Study Duration (3 years, 10 months).
We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected durig all Study Duration (3 years, 10 months).
We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected durig all Study Duration (3 years, 10 months).
We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected durig all Study Duration (3 years, 10 months).
We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
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Additional Information
MD Vittorio Stefoni
Institute of Hematology "L. e A. Seràgnoli", AOU Policlinico S.Orsola-Malpighi Via Massarenti, 9 - 40138 Bologna Italy
Phone: +39 0512143680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place