Trial Outcomes & Findings for Pidilizumab in Treating Patients With Stage III-IV Diffuse Large B-Cell Lymphoma Following First Remission (NCT NCT02530125)

Last Updated: 2018-03-19

Results Overview

Response will be defined as the proportion of CD4+CD25+PD-L1+ T lymphocytes and CD4+CD62L+CD127+ T lymphocytes responders. Responders are defined as either a) a 50% increase or b) a half standard deviation increase in lymphocyte subsets. Lymphocyte subsets will be evaluated by flow cytometry on peripheral blood obtained at specified time points through the treatment period.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.

Results posted on

2018-03-19

Participant Flow

The study opened for accrual on August 4, 2016 with an accrual goal of up to 30 patients. The manufacturer of pidilizumab requested accrual be suspended on November 15, 2016 and the study was permanently closed to accrual. The manufacturer discontinued pidilizumab due to issues with supply. 4 patients were registered and treated with pidilizumab.

Participant milestones

Participant milestones
Measure	Treatment (Pidilizumab) Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pidilizumab: Given IV
Completed Treatment STARTED	4
Completed Treatment COMPLETED	3
Completed Treatment NOT COMPLETED	1
Followed for Survival for 2 Years STARTED	3
Followed for Survival for 2 Years COMPLETED	0
Followed for Survival for 2 Years NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Pidilizumab) Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pidilizumab: Given IV
Completed Treatment Early termination of study	1
Followed for Survival for 2 Years Early termination of study	3

Baseline Characteristics

Pidilizumab in Treating Patients With Stage III-IV Diffuse Large B-Cell Lymphoma Following First Remission

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Pidilizumab) n=4 Participants Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pidilizumab: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.

Population: Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up to the point of termination of the study.

Population: This is only based of of 4 patients that received treatment of pidilizumab. Study terminated early due to manufacturer decision to discontinue pidilizumab.

Adverse events (AEs) were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. In general, AEs are graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

Outcome measures

Outcome measures
Measure	Treatment (Pidilizumab) n=4 Participants Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pidilizumab: Given IV
The Frequency and Severity of Toxicity - Number of Grade 1, 2, 3, 4, and 5, Adverse Events Experienced During Treatment of Pidilizumab Defined by NCI CTCAE v 4.03. Grade 1	55 Adverse events
The Frequency and Severity of Toxicity - Number of Grade 1, 2, 3, 4, and 5, Adverse Events Experienced During Treatment of Pidilizumab Defined by NCI CTCAE v 4.03. Grade 2	10 Adverse events
The Frequency and Severity of Toxicity - Number of Grade 1, 2, 3, 4, and 5, Adverse Events Experienced During Treatment of Pidilizumab Defined by NCI CTCAE v 4.03. Grade 3	2 Adverse events
The Frequency and Severity of Toxicity - Number of Grade 1, 2, 3, 4, and 5, Adverse Events Experienced During Treatment of Pidilizumab Defined by NCI CTCAE v 4.03. Grade 4	0 Adverse events
The Frequency and Severity of Toxicity - Number of Grade 1, 2, 3, 4, and 5, Adverse Events Experienced During Treatment of Pidilizumab Defined by NCI CTCAE v 4.03. Grade 5	0 Adverse events

SECONDARY outcome

Timeframe: From study enrollment until death, or until last contact, assessed up to 2 years. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.

Population: Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.

To estimate the overall survival (OS) at 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.

Population: Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.

To estimate the progression free survival (PFS) at 2 years. PFS will be defined as time from study enrollment until the first occurrence of disease relapse, progression, re-initiation of cytotoxic chemotherapy, or death due to disease, or until last contact if the patient did not experience any of these.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.

Population: Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.

To estimate time to second line chemotherapy (TSLC) at 2 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.

Population: Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.

Peripheral blood obtained at day 1 and day 127 will be analyzed and levels will be compared to evaluate for a change (increase/decrease) following treatment with pidilizumab.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.

Population: Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.

Peripheral blood will be tested for serum levels of TNF-α, IFN-γ, IL-2, IL- 7, IL-9, and galectin-1. Levels will be compared from specified time points through treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.

Population: Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.

Tissue sample slides from the diagnostic biopsy will be evaluated by immunohistochemistry for expression of PD-1 and PD-L1. Presence/absence (binary) of PD-1 and PD-L1 will be correlated with response to pidilizumab and clinical outcomes.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Pidilizumab)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Pidilizumab) n=4 participants at risk Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pidilizumab: Given IV
Skin and subcutaneous tissue disorders Basal cell carcinoma	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.

Other adverse events

Other adverse events
Measure	Treatment (Pidilizumab) n=4 participants at risk Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pidilizumab: Given IV
Blood and lymphatic system disorders Anemia	50.0% 2/4 • Number of events 3 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Gastrointestinal disorders Constipation	50.0% 2/4 • Number of events 4 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Gastrointestinal disorders Dysphagia	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Gastrointestinal disorders Diarrhea	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
General disorders Fatigue	50.0% 2/4 • Number of events 2 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
General disorders Edema limbs	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
General disorders Fever	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Investigations Neutrophil count decrease	50.0% 2/4 • Number of events 2 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Investigations Alanine aminotransferase increased	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Investigations Lymphocyte count decreased	75.0% 3/4 • Number of events 8 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Investigations Platelet count decreased	50.0% 2/4 • Number of events 3 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Investigations White blood cell decreased	50.0% 2/4 • Number of events 7 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Infections and infestations Bronchial infection	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Psychiatric disorders Anxiety	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Psychiatric disorders Depression	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Nervous system disorders Lethargy	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Nervous system disorders Paraesthesia	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Metabolism and nutrition disorders Hyperglycemia	75.0% 3/4 • Number of events 7 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Metabolism and nutrition disorders Hyperalbuminemia	50.0% 2/4 • Number of events 4 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Metabolism and nutrition disorders Hyponatremia	50.0% 2/4 • Number of events 2 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Metabolism and nutrition disorders Hypocalcemia	50.0% 2/4 • Number of events 2 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Renal and urinary disorders Oliguria	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Respiratory, thoracic and mediastinal disorders Post nasal drip	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 2 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Vascular disorders Hypertension	25.0% 1/4 • Number of events 2 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Vascular disorders Hematoma	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.
Skin and subcutaneous tissue disorders Pruritus	25.0% 1/4 • Number of events 1 • Adverse events were collected over 1 year, 4 months [Time frame: Start treatment through 127 days and then every 3 months up to 2 years] The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.

Additional Information

Winter, Jane MD

Northwestern University

Phone: 312 695 4033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place