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A Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory PMLBCL (FIL_SGN01)

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ClinicalTrials.gov Identifier: NCT02423291
Recruitment Status : Completed
First Posted : April 22, 2015
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Mediastinal Large B Cell Lymphoma
Intervention Drug: Brentuximab Vedotin
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vial for IV Infusion
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 15 [1]
Completed 0 [2]
Not Completed 15
Reason Not Completed
Lack of Efficacy             14
Adverse Event             1
[1]
Patients enrolled
[2]
Patients that have completed therapy
Arm/Group Title Vial for IV Infusion
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  86.7%
>=65 years
2
  13.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
37  (18.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
10
  66.7%
Male
5
  33.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 15 participants
15
1.Primary Outcome
Title Overall Objective Response Rate in Patients With Relapsed or Refractory PMLBCL
Hide Description 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.
Time Frame 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
Trial was closed due to drug inefficacy on 14/Jul/2016 (last enrollment on 30/Jun/2015). Details in the Outcome Measure Data Table.
Arm/Group Title Vial for IV Infusion
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
Quick PD
11
  73.3%
PD after 1 cycle
1
   6.7%
PD after 2 cycle
1
   6.7%
PR
1
   6.7%
SAE not related to drug
1
   6.7%
Time Frame Adverse event data were collected durig all Study Duration (3 years, 10 months).
Adverse Event Reporting Description We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
 
Arm/Group Title Vial for IV Infusion
Hide Arm/Group Description

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.

All-Cause Mortality
Vial for IV Infusion
Affected / at Risk (%)
Total   3/15 (20.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Vial for IV Infusion
Affected / at Risk (%) # Events
Total   1/15 (6.67%)    
Cardiac disorders   
Tachycardia 1 [1]  1/15 (6.67%)  1
1
Term from vocabulary, CTCAE (4.0)
[1]
CARDIAC DISORDER Tachycardia
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vial for IV Infusion
Affected / at Risk (%) # Events
Total   15/15 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  2/15 (13.33%)  2
Leukopenia  1/15 (6.67%)  1
Granulocytopenia  3/15 (20.00%)  3
Thrombocytopenia  2/15 (13.33%)  2
Cardiac disorders   
Atrial fibrillation  1/15 (6.67%)  1
Gastrointestinal disorders   
Intestinal perforation  1/15 (6.67%)  1
General disorders   
Fatigue  1/15 (6.67%)  1
Investigations   
Alanine aminotransferase increased  2/15 (13.33%)  2
Gamma-glutamyltransferase increased  1/15 (6.67%)  1
Nervous system disorders   
Peripheral neuropathy (NEC)  1/15 (6.67%)  1
Skin and subcutaneous tissue disorders   
Erythema  1/15 (6.67%)  1
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: MD Vittorio Stefoni
Organization: Institute of Hematology “L. e A. Seràgnoli”, AOU Policlinico S.Orsola-Malpighi Via Massarenti, 9 - 40138 Bologna Italy
Phone: +39 0512143680
Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT02423291     History of Changes
Other Study ID Numbers: FIL_SGN01
First Submitted: September 30, 2013
First Posted: April 22, 2015
Results First Submitted: February 24, 2017
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017