Trial Outcomes & Findings for Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma (NCT NCT01318317)
NCT ID: NCT01318317
Last Updated: 2025-04-25
Results Overview
Number of DLTs per dose level are reported. A DLT is defined as: Any grade 3 or higher toxicity, with the exception of expected adverse events; and designated as definitely or probably related (level of attribution) to the infusion of the TCM cells; and occurring within 28 days of T-cell infusion; Any toxicity requiring the use of steroids to ablate side effects attributable to the infusion of the TCM cells, and occurring within 28 days of T-cell infusion; Any toxicity which is a lower grade, but that increases in grade to a grade 3 or higher as a direct result of the TCM, and occurring within 28 days of T-cell infusion; Any grade 2 or greater autoimmune toxicity, and occurring within 28 days of T-cell infusion.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Within 28 days of T-cell infusion
Results posted on
2025-04-25
Participant Flow
Three additional participants underwent leukapheresis, however, two were ineligible for transplant and the third refused additional treatment and therefore were not assigned a dose level.
Participant milestones
| Measure |
Dose Level 0 (25 x 10^6 CAR+ T-cells)
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. All patients receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 1 (50 x 10^6 CAR+ T-cells)
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. All patients receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 2 (100 x 10^6 CAR+ T-cells)
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. All patients receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
4
|
3
|
|
Overall Study
COMPLETED
|
1
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Dose Level 0 (25 x 10^6 CAR+ T-cells)
n=1 Participants
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 1 (50 x 10^6 CAR+ T-cells)
n=4 Participants
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 2 (100 x 10^6 CAR+ T-cells)
n=3 Participants
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75 years
n=5 Participants
|
60 years
n=7 Participants
|
58 years
n=5 Participants
|
62 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Disease histology
Diffuse Large B-Cell Lymphoma
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Disease histology
Mantle Cell Lymphoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 28 days of T-cell infusionNumber of DLTs per dose level are reported. A DLT is defined as: Any grade 3 or higher toxicity, with the exception of expected adverse events; and designated as definitely or probably related (level of attribution) to the infusion of the TCM cells; and occurring within 28 days of T-cell infusion; Any toxicity requiring the use of steroids to ablate side effects attributable to the infusion of the TCM cells, and occurring within 28 days of T-cell infusion; Any toxicity which is a lower grade, but that increases in grade to a grade 3 or higher as a direct result of the TCM, and occurring within 28 days of T-cell infusion; Any grade 2 or greater autoimmune toxicity, and occurring within 28 days of T-cell infusion.
Outcome measures
| Measure |
Dose Level 0 (25 x 10^6 CAR+ T-cells)
n=1 Participants
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 1 (50 x 10^6 CAR+ T-cells)
n=4 Participants
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 2 (100 x 10^6 CAR+ T-cells)
n=3 Participants
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 days post T cell infusionPopulation: 1 participant in dose level 1 did not have any whole blood samples to analyze. Overall median was reported due to small samples sizes in each dose level.
Peak expansion of WPRE is expressed in CAR copy number/mL of blood is summarized with median and range
Outcome measures
| Measure |
Dose Level 0 (25 x 10^6 CAR+ T-cells)
n=7 Participants
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 1 (50 x 10^6 CAR+ T-cells)
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 2 (100 x 10^6 CAR+ T-cells)
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
|---|---|---|---|
|
Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE) Detection Above Background
|
280 CAR copy number/mL
Interval 0.0 to 925.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days post T cell infusionPopulation: 1 participant in dose level 1 did not have any whole blood samples to analyze. Overall mean was reported due to small samples sizes in each dose level.
WPRE persistence of quantifiable CD19 CAR summarized with mean and standard deviation
Outcome measures
| Measure |
Dose Level 0 (25 x 10^6 CAR+ T-cells)
n=7 Participants
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 1 (50 x 10^6 CAR+ T-cells)
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 2 (100 x 10^6 CAR+ T-cells)
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
|---|---|---|---|
|
Number of Days of Quantifiable CD19 CAR Post T-cell Infusion
|
18.25 days
Standard Deviation 12.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 21 days post T-cell infusionCount of participants who fail to engraft post transplant.
Outcome measures
| Measure |
Dose Level 0 (25 x 10^6 CAR+ T-cells)
n=1 Participants
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 1 (50 x 10^6 CAR+ T-cells)
n=4 Participants
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 2 (100 x 10^6 CAR+ T-cells)
n=3 Participants
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
|---|---|---|---|
|
Failure to Engraft
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearEstimated using the Kaplan-Meier methods. Progression is defined using the revised IWG response criteria, as any new lesion or increase by ≥50% of previously involved sites from nadir.
Outcome measures
| Measure |
Dose Level 0 (25 x 10^6 CAR+ T-cells)
n=8 Participants
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 1 (50 x 10^6 CAR+ T-cells)
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 2 (100 x 10^6 CAR+ T-cells)
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
|---|---|---|---|
|
Progression-free Survival at 1 Year
|
50 percentage of participants
Interval 16.0 to 84.0
|
—
|
—
|
Adverse Events
Dose Level 0 (25 x 10^6 CAR+ T-cells)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 1 (50 x 10^6 CAR+ T-cells)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Dose Level 2 (100 x 10^6 CAR+ T-cells)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Level 0 (25 x 10^6 CAR+ T-cells)
n=1 participants at risk
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 1 (50 x 10^6 CAR+ T-cells)
n=4 participants at risk
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 2 (100 x 10^6 CAR+ T-cells)
n=3 participants at risk
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified (incl cysts and polyps)- Other
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
Other adverse events
| Measure |
Dose Level 0 (25 x 10^6 CAR+ T-cells)
n=1 participants at risk
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 1 (50 x 10^6 CAR+ T-cells)
n=4 participants at risk
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
Dose Level 2 (100 x 10^6 CAR+ T-cells)
n=3 participants at risk
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
1/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Cardiac disorders
Sinus tachycardia
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Abdominal distension
|
100.0%
1/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
1/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Flatulence
|
100.0%
1/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
1/1 • During and after treatment, up to 38 months
|
75.0%
3/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • During and after treatment, up to 38 months
|
75.0%
3/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
General disorders
Chills
|
100.0%
1/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
General disorders
Fatigue
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
General disorders
Fever
|
100.0%
1/1 • During and after treatment, up to 38 months
|
75.0%
3/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
General disorders
Injection site reaction
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
General disorders
Pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
General disorders
Edema limbs
|
100.0%
1/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
General disorders
Infusion related reaction
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
General disorders
Localized edema
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Infections and infestations
Eye infection
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Infections and infestations
Soft tissue infection
|
100.0%
1/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • During and after treatment, up to 38 months
|
75.0%
3/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Investigations
Cholesterol high
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Investigations
Creatinine increased
|
0.00%
0/1 • During and after treatment, up to 38 months
|
75.0%
3/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Investigations
Weight loss
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Investigations
White blood cell decreased
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
100.0%
1/1 • During and after treatment, up to 38 months
|
75.0%
3/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
1/1 • During and after treatment, up to 38 months
|
75.0%
3/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
100.0%
1/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
100.0%
1/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Nervous system disorders
Dysgeusia
|
100.0%
1/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • During and after treatment, up to 38 months
|
75.0%
3/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • During and after treatment, up to 38 months
|
75.0%
3/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Psychiatric disorders
Insomnia
|
100.0%
1/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Psychiatric disorders
Restlessness
|
100.0%
1/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
100.0%
1/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • During and after treatment, up to 38 months
|
50.0%
2/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • During and after treatment, up to 38 months
|
75.0%
3/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
100.0%
1/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
100.0%
1/1 • During and after treatment, up to 38 months
|
75.0%
3/4 • During and after treatment, up to 38 months
|
66.7%
2/3 • During and after treatment, up to 38 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/1 • During and after treatment, up to 38 months
|
0.00%
0/4 • During and after treatment, up to 38 months
|
33.3%
1/3 • During and after treatment, up to 38 months
|
|
Vascular disorders
Hypertension
|
100.0%
1/1 • During and after treatment, up to 38 months
|
100.0%
4/4 • During and after treatment, up to 38 months
|
100.0%
3/3 • During and after treatment, up to 38 months
|
|
Vascular disorders
Lymphedema
|
0.00%
0/1 • During and after treatment, up to 38 months
|
25.0%
1/4 • During and after treatment, up to 38 months
|
0.00%
0/3 • During and after treatment, up to 38 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place