Trial Outcomes & Findings for Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma (NCT NCT05993299)

Last Updated: 2024-10-22

Results Overview

ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). 95% CI is based on Clopper-Pearson exact confidence interval.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Up to approximately 36 months

Results posted on

2024-10-22

Participant Flow

This study is a sub study of the master protocol (NCT03967223). The results presented are until the primary completion date. Data collection is still ongoing and additional results will be provided after study completion.

Participant milestones

Participant milestones
Measure	Letetresgene Autoleucel (Lete-cel) Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m\^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m\^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10\^9 to 15×10\^9 transduced T cells.
Overall Study STARTED	7
Overall Study Received T Cell Infusion	5
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Letetresgene Autoleucel (Lete-cel) Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m\^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m\^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10\^9 to 15×10\^9 transduced T cells.
Overall Study Did not meet treatment eligibility criteria	2
Overall Study Ongoing	4

Baseline Characteristics

Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Letetresgene Autoleucel (Lete-cel) n=7 Participants Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m\^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m\^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10\^9 to 15×10\^9 transduced T cells.
Age, Continuous	49.4 years STANDARD_DEVIATION 16.70 • n=5 Participants
Age, Customized <=18 years	1 Participants n=5 Participants
Age, Customized 19-64 years	6 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 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	7 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 Canada	1 participants n=5 Participants
Region of Enrollment Netherlands	2 participants n=5 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 36 months

Population: Modified intent-to-treat (mITT) population included all participants who received any dose of Lete-cel.

Outcome measures

Outcome measures
Measure	Letetresgene Autoleucel (Lete-cel) n=5 Participants Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m\^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m\^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10\^9 to 15×10\^9 transduced T cells.
Overall Response Rate (ORR)	80 percentage of participants Interval 28.4 to 99.5

SECONDARY outcome

Timeframe: Up to approximately 54 months

Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 54 months

Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease as assessed by local investigators, or death among participants with a confirmed response per RECIST 1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 36 months

Population: Modified intent-to-treat (mITT) population included all participants who received any dose of Lete-cel.

DCR is defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) with a minimal 12 weeks (84 days ± 7 day window) duration relative to the total number of participants within the analysis population at the time of primary analysis as determined by local investigators per RECIST v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. The disease progression (PD) is defined as the date of radiological disease progression based on imaging data per RECIST v1.1. 95% CI is based on Clopper-Pearson exact confidence interval.

Outcome measures

Outcome measures
Measure	Letetresgene Autoleucel (Lete-cel) n=5 Participants Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m\^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m\^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10\^9 to 15×10\^9 transduced T cells.
Disease Control Rate (DCR)	80.0 Percentage of Participants Interval 28.4 to 99.5

SECONDARY outcome

Timeframe: Up to approximately 54 months

PFS is defined as the interval of time between from the date of T-cell infusion to the earliest date of radiological progression of disease (PD) as assessed by local investigator per RECIST v1.1, or death due to any cause. The PD is defined as the date of radiological disease progression based on imaging data per RECIST v1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 54 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 54 months

An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included cytokine release syndrome (CRS), hematopoietic cytopenias (including pancytopenia and aplastic anemia), graft vs host disease (GVHD), ICANS, Guillain-Barre syndrome, treatment-related inflammatory response at tumor site(s), and neutropenia Grade 4 lasting ≥28 days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 54 months

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs and SAEs were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 54 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 54 months

RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 54 months

Instances of Insertional Oncogenesis (IO) was summarized descriptively.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 to Day 14

Population: Pharmacokinetic (PK) population included participants in the safety population from whom at least one persistence sample was obtained, analyzed and was measurable.

Cmax was defined as maximum observed persistence, determined directly from the persistence-time data. Blood samples were collected for PK analysis.

Outcome measures

Outcome measures
Measure	Letetresgene Autoleucel (Lete-cel) n=5 Participants Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m\^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m\^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10\^9 to 15×10\^9 transduced T cells.
Maximum Transgene Expansion (Cmax)	119701.64 Copies per microgram genomic DNA Geometric Coefficient of Variation 68.267

SECONDARY outcome

Timeframe: Day 1 to Day 14

Population: Pharmacokinetic (PK) population

Tmax was defined as time to reach Cmax, determined directly from the persistence-time data. Blood samples were collected for PK analysis.

Outcome measures

Outcome measures
Measure	Letetresgene Autoleucel (Lete-cel) n=5 Participants Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m\^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m\^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10\^9 to 15×10\^9 transduced T cells.
Time to Cmax (Tmax)	6.90 Days Interval 1.9 to 13.6

SECONDARY outcome

Timeframe: Up to 28 days

Population: Pharmacokinetic (PK) population

Area under the persistence-time curve from time zero to Day 28. Blood samples were collected for PK analysis.

Outcome measures

Outcome measures
Measure	Letetresgene Autoleucel (Lete-cel) n=5 Participants Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m\^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m\^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10\^9 to 15×10\^9 transduced T cells.
Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28])	1911782.96 Days*copies per microgram genomic DNA Geometric Coefficient of Variation 53.709

Adverse Events

Letetresgene Autoleucel (Lete-cel)

Serious events: 4 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Letetresgene Autoleucel (Lete-cel) n=7 participants at risk Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m\^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m\^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10\^9 to 15×10\^9 transduced T cells.
Gastrointestinal disorders Gastrointestinal haemorrhage	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Gastrointestinal disorders Small intestinal obstruction	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Immune system disorders Cytokine release syndrome	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Immune system disorders Graft versus host disease	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Blood and lymphatic system disorders Anaemia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Injury, poisoning and procedural complications Radiation pneumonitis	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Investigations Weight decreased	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Metabolism and nutrition disorders Dehydration	14.3% 1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Respiratory, thoracic and mediastinal disorders Haemoptysis	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.

Other adverse events

Other adverse events
Measure	Letetresgene Autoleucel (Lete-cel) n=7 participants at risk Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m\^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m\^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10\^9 to 15×10\^9 transduced T cells.
Immune system disorders Cytokine release syndrome	57.1% 4/7 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Immune system disorders Graft versus host disease	14.3% 1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Infections and infestations COVID-19	42.9% 3/7 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Infections and infestations Cytomegalovirus infection reactivation	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Infections and infestations Enterocolitis infectious	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Infections and infestations Pneumonia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Infections and infestations Rhinitis	14.3% 1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Investigations Alanine aminotransferase increased	42.9% 3/7 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Investigations Aspartate aminotransferase increased	28.6% 2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Investigations Blood fibrinogen decreased	28.6% 2/7 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Investigations Neutrophil count decreased	28.6% 2/7 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Investigations Platelet count decreased	28.6% 2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Investigations White blood cell count decreased	28.6% 2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Investigations Blood alkaline phosphatase increased	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Investigations Blood lactate dehydrogenase increased	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Investigations Lymphocyte count decreased	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Investigations Weight decreased	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Gastrointestinal disorders Constipation	42.9% 3/7 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Gastrointestinal disorders Gastrooesophageal reflux disease	42.9% 3/7 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Gastrointestinal disorders Nausea	42.9% 3/7 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Gastrointestinal disorders Abdominal pain	28.6% 2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Gastrointestinal disorders Abdominal discomfort	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Gastrointestinal disorders Diarrhoea	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Gastrointestinal disorders Dysphagia	14.3% 1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Gastrointestinal disorders Frequent bowel movements	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
General disorders Fatigue	57.1% 4/7 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
General disorders Oedema peripheral	28.6% 2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
General disorders Axillary pain	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
General disorders Catheter site phlebitis	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
General disorders Non-cardiac chest pain	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
General disorders Pyrexia	14.3% 1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Respiratory, thoracic and mediastinal disorders Dyspnoea	42.9% 3/7 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Respiratory, thoracic and mediastinal disorders Cough	28.6% 2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Respiratory, thoracic and mediastinal disorders Dysphonia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Respiratory, thoracic and mediastinal disorders Productive cough	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Skin and subcutaneous tissue disorders Rash maculo-papular	28.6% 2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Skin and subcutaneous tissue disorders Alopecia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Skin and subcutaneous tissue disorders Dry skin	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Skin and subcutaneous tissue disorders Onychomadesis	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Skin and subcutaneous tissue disorders Pruritus	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Blood and lymphatic system disorders Anaemia	28.6% 2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Blood and lymphatic system disorders Eosinophilia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Blood and lymphatic system disorders Neutropenia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Metabolism and nutrition disorders Hypokalaemia	28.6% 2/7 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Metabolism and nutrition disorders Hypervolaemia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Metabolism and nutrition disorders Hypoalbuminaemia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Metabolism and nutrition disorders Hypocalcaemia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Metabolism and nutrition disorders Hyponatraemia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Metabolism and nutrition disorders Hypophosphataemia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Musculoskeletal and connective tissue disorders Arthralgia	28.6% 2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Musculoskeletal and connective tissue disorders Bone pain	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Nervous system disorders Dysgeusia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Nervous system disorders Headache	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Nervous system disorders Paraesthesia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Cardiac disorders Sinus tachycardia	14.3% 1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Hepatobiliary disorders Hyperbilirubinaemia	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Injury, poisoning and procedural complications Infusion related reaction	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Psychiatric disorders Anxiety	14.3% 1/7 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Psychiatric disorders Depression	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Psychiatric disorders Insomnia	14.3% 1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Reproductive system and breast disorders Menstruation irregular	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
Vascular disorders Hot flush	14.3% 1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion. All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER