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This single-arm, multicenter Phase 2 trial will treat adult patients who have relapsed or refractory B-ALL with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to leukemia cells that express the CD19 protein on the cell surface. The study will determine if these modified T cells (called JCAR015) help the body's immune system eliminate leukemia cells. The trial will also study the safety of treatment with JCAR015, how long JCAR015 cells stay in the patient's body, the extent to which JCAR015 eliminates minimal residual disease, and the impact of this treatment on survival.
This is a single-arm, multicenter Phase 2 study to determine the efficacy and safety of JCAR015 in adult patients with relapsed or refractory B-ALL. The study will have the following sequential phases: Part A (screening, leukapheresis, cell product preparation, and cytoreductive chemotherapy) and Part B (treatment and follow-up). The follow-up period for each participant is approximately 12 months after the final JCAR015 infusion. The total duration of the study is expected to be approximately 3 years. Long-term follow-up for survival, toxicity, and viral vector safety will continue under a separate long-term follow-up protocol per health regulatory authority guidelines, currently up to 15 years after the last JCAR015 infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JCAR015 (CD19-targeted CAR T cells) | Experimental | JCAR015 was administered as two intravenous (IV) infusions separated by 14 to 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JCAR015 (CD19-targeted CAR T cells) | Biological | Part A: Following leukapheresis and concurrent with generation of JCAR015, participants received, at the Investigator's discretion, cytoreductive chemotherapy based on the Investigator's choice of regimens and/or supportive care. Part B: Participants who were eligible for treatment in Part B received two IV doses of JCAR015 CAR T cells separated by 14 to 28 days. JCAR015 infusion was preceded by lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematopoietic Recovery (CRi), as Determined by an Independent Review Committee (IRC) | Overall remission rate (ORR) is defined as the percentage of participants with CR or CRi based on IRC assessment. For CR, all of the following must be met: (1) in bone marrow, trilineage hematopoiesis and < 5% blasts; (2) in peripheral blood, neutrophils > 1,000/µL, platelets > 100,000/µL, and circulating blasts < 1%; (3) no clinical evidence of extramedullary disease by physical examination and no symptoms suggestive of CNS involvement (if additional assessments such as CSF assessment by lumbar puncture or Ommaya reservoir tap, CNS imaging, or biopsy are performed, results must show no evidence of disease); (4) no platelet and/or neutrophil transfusions ≤ 7 days before the date of peripheral blood sampling, and (5) no clinical evidence of recurrence for 4 weeks. For CRi, all criteria for CR are met except that one or more of the following exists in the peripheral blood: neutrophils ≤ 1,000/µL, platelets ≤ 100,000/µL, or platelet transfusions ≤ 7 days before blood sampling. | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CR or CRi, as Determined by an IRC | ORR is defined as the percentage of participants with CR or CRi based on IRC assessment (refer to criteria in Outcome Measure #1) | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC |
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Inclusion Criteria:
Age ≥ 18 years at the time of consent
Relapsed or refractory B-ALL, defined as:
Morphological evidence of disease in bone marrow (at least 5% blasts)
Evidence of CD19 expression
Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2 at the time of screening
Adequate pulmonary, renal, hepatic, and cardiac function
Adequate central or peripheral vascular access for leukapheresis procedure
Exclusion Criteria:
Isolated extramedullary disease relapse
Concomitant genetic syndrome or other known bone marrow failure syndrome
Burkitt's lymphoma/leukemia or chronic myelogenous leukemia lymphoid blast crisis (p210 BCR-ABL+)
Prior malignancy, unless treated with curative intent and with no evidence of active disease present for > 5 years before screening
Prior treatment with any gene therapy product
Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
Systemic fungal, bacterial, viral, or other infection that is not controlled, at the time of screening
Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening
Active central nervous system (CNS) involvement by malignancy (defined as CNS-3 per National Comprehensive Cancer Network [NCCN] guidelines)
History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Participation in an investigational research study using an investigational agent within 30 days of screening
History of treatment with a murine-derived biological product other than blinatumomab unless subject has been shown to be negative for human-anti-mouse-antibodies (HAMA) prior to or during screening
Pregnant or nursing women
Use of prohibited medications:
Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
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| Name | Affiliation | Role |
|---|---|---|
| Nikolaus Trede, MD, PhD | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35295 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24553386 | Background | Davila ML, Riviere I, Wang X, Bartido S, Park J, Curran K, Chung SS, Stefanski J, Borquez-Ojeda O, Olszewska M, Qu J, Wasielewska T, He Q, Fink M, Shinglot H, Youssif M, Satter M, Wang Y, Hosey J, Quintanilla H, Halton E, Bernal Y, Bouhassira DC, Arcila ME, Gonen M, Roboz GJ, Maslak P, Douer D, Frattini MG, Giralt S, Sadelain M, Brentjens R. Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia. Sci Transl Med. 2014 Feb 19;6(224):224ra25. doi: 10.1126/scitranslmed.3008226. | |
| 23550147 |
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Participants were adults with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (ALL).
A total of 82 participants were enrolled at 15 study centers within the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | JCAR015 | Participants received up to two intravenous (IV) infusions of JCAR015 separated by 14 to 28 days. In Part A, participants received at the Investigator's discretion, cytoreductive chemotherapy based on the Investigator's choice and/or supportive care. In Part B, eligible participants received two IV doses of JCAR015 CAR T cells. JCAR015 infusion was preceded by lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A Screening Through Leukapheresis |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 14, 2016 | Apr 23, 2018 |
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Best overall response (BOR) is defined as the best disease response recorded from the time of the last JCAR015 infusion until the start of another anticancer therapy (refer to Outcome Measure #1 for criteria for CR and CRi). |
| Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC | BOR is defined as the best disease response recorded from the time of the last JCAR015 infusion until the start of another anticancer therapy (refer to Outcome Measure #1 for criteria for CR and CRi). | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| Percentage of Participants Who Achieved a Minimal Residual Disease (MRD)-Negative CR or CRi | Percentage of participants who achieved a CR or CRi, as determined by an IRC, with no evidence of MRD in the bone marrow (refer to Outcome Measure #1 for criteria for CR and CRi). MRD-negative is defined as undetectable leukemic cells in the bone marrow as determined by a polymerase chain reaction (PCR)-based assay. | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| Percentage of Participants Who Achieved a MRD-Negative CR or CRi | Percentage of participants who achieved a CR or CRi, as determined by an IRC, with no evidence of MRD in the bone marrow (refer to Outcome Measure #1 for criteria for CR and CRi). MRD-negative is defined as undetectable leukemic cells in the bone marrow as determined by a PCR-based assay. | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| Relapse-Free Survival (RFS), as Determined by an IRC | RFS is defined as the interval from the first documentation of CR or CRi (refer to Outcome Measure #1) to the earlier date of relapse or death due to any cause. Participants who proceeded to hematopoietic stem cell transplant (HSCT) after JCAR015 infusion were censored at the time of HSCT. | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| RFS, as Determined by an IRC | RFS is defined as the interval from the first documentation of CR or CRi (refer to Outcome Measure #1) to the earlier date of relapse or death due to any cause. Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT. | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| Event-Free Survival (EFS) | EFS is defined as the time from the date of the first JCAR015 infusion to the earliest of the following events: death from any cause, relapse, or treatment failure (defined as no response and subsequent discontinuation from the study for adverse event, lack of efficacy or progressive disease, or new anticancer therapy). Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT. | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| EFS | EFS is defined as the time from the date of the first JCAR015 infusion to the earliest of the following events: death from any cause, relapse, or treatment failure (defined as no response and subsequent discontinuation from the study for adverse event, lack of efficacy or progressive disease, or new anticancer therapy). Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT. | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| Overall Survival (OS) | OS is defined as the interval from the date of the first JCAR015 infusion to the date of death due to any reason. | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| OS | OS is defined as the interval from the date of the first JCAR015 infusion to the date of death due to any reason. | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| Duration of Remission (DOR) as Determined by an IRC | DOR is defined as the interval from the first documentation of CR or CRi to the earlier date of relapse or death due to ALL. | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC, at Month 6 After the Final JCAR015 Infusion | ORR at Month 6 is defined as the percentage of participants who achieved a CR or CRi at Month 6 after the final JCAR015 infusion without HSCT during the time period between the final JCAR015 infusion and the Month 6 response assessment (refer to Outcome Measure #1 for criteria for CR and CRi). | Day 1 (first JCAR015 infusion) up to 6 months after the last JCAR015 infusion |
| Percentage of Participants Who Achieved a Morphologic Remission Within 6 Months After the Final JCAR015 Infusion and Then Proceeded to HSCT | Percentage of participants who achieved a morphologic remission within 6 months after the final JCAR015 infusion and then proceeded to HSCT prior to 12 months after the final JCAR015 infusion | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
| Maximum Concentration of JCAR015 (Cmax) in the Peripheral Blood by Quantitative Polymerase Chain Reaction (qPCR) | Cmax is defined as the highest measured number of copies of JCAR015 transgene per microgram of genomic DNA in peripheral blood cells as assessed by qPCR. | Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable) |
| Maximum Concentration of JCAR015 (Cmax) in the Peripheral Blood by Flow Cytometry | Cmax is defined as the highest measured concentration of JCAR015 CAR T cells per microliter of peripheral blood as measured by flow cytometry. | Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable) |
| Time to Maximum Concentration of JCAR015 (Tmax) in the Peripheral Blood as Measured by qPCR | Tmax is defined as the time after the JCAR015 infusion at which the maximum concentration (Cmax) as measured by qPCR is observed. If Cmax occurred after the second infusion, Tmax was calculated from the time of the second infusion. | Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable) |
| Tmax in the Peripheral Blood as Measured by Flow Cytometry | Tmax is defined as the time after the JCAR015 infusion at which the Cmax as measured by flow cytometry of the JCAR015 CAR is observed. If Cmax occurred after the second infusion, Tmax was calculated from the time of the second infusion. | Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable) |
| Area Under the Concentration-vs-Time Curve (AUC) for JCAR015 in the Peripheral Blood as Measured by qPCR | AUC is defined as the area under the concentration-vs-time curve from Day 1 to Day 29 after the first JCAR015 infusion as measured by qPCR of the JCAR015 transgene. AUC calculation includes pharmacokinetic (PK) results up to the second JCAR015 infusion for subjects who received the second infusion prior to Day 29 after the first JCAR015 infusion. | Pre-dose Day 1 of the first JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion |
| AUC for JCAR015 in the Peripheral Blood as Measured by Flow Cytometry | AUC is defined as the area under the concentration-vs-time curve from Day 1 to Day 29 after the first JCAR015 infusion as measured by flow cytometry of the JCAR015 CAR. AUC calculation includes PK results up to the second JCAR015 infusion for subjects who received the second infusion prior to Day 29 after the first JCAR015 infusion. | Pre-dose Day 1 of the first JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion |
| Percentage of Participants Who Developed Anti-Therapeutic Antibodies Against JCAR015 | Percentage of participants who developed anti-therapeutic antibodies against JCAR015 | Part B Screening; Day 14 after the first JCAR015 infusion; Pre-Dose Day 1 of the second JCAR015 infusion; Day 14 after the second JCAR015 infusion; and Day 28, Month 3, Month 6, and Month 12 after the last JCAR015 infusion |
| City of Hope |
| Duarte |
| California |
| 91010 |
| United States |
| University of California | San Francisco | California | 94143 | United States |
| University of Colorado Denver -- Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| Sylvester Comprehensive Cancer Center/UMHC | Miami | Florida | 33136 | United States |
| The Blood and Marrow Transplant Program at Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Northwestern University Robert H Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Sidney Kimmel Comprehensive Cancer Center @ Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Background |
| Sadelain M, Brentjens R, Riviere I. The basic principles of chimeric antigen receptor design. Cancer Discov. 2013 Apr;3(4):388-98. doi: 10.1158/2159-8290.CD-12-0548. Epub 2013 Apr 2. |
| 23515080 | Background | Brentjens RJ, Davila ML, Riviere I, Park J, Wang X, Cowell LG, Bartido S, Stefanski J, Taylor C, Olszewska M, Borquez-Ojeda O, Qu J, Wasielewska T, He Q, Bernal Y, Rijo IV, Hedvat C, Kobos R, Curran K, Steinherz P, Jurcic J, Rosenblat T, Maslak P, Frattini M, Sadelain M. CD19-targeted T cells rapidly induce molecular remissions in adults with chemotherapy-refractory acute lymphoblastic leukemia. Sci Transl Med. 2013 Mar 20;5(177):177ra38. doi: 10.1126/scitranslmed.3005930. |
| 21849486 | Background | Brentjens RJ, Riviere I, Park JH, Davila ML, Wang X, Stefanski J, Taylor C, Yeh R, Bartido S, Borquez-Ojeda O, Olszewska M, Bernal Y, Pegram H, Przybylowski M, Hollyman D, Usachenko Y, Pirraglia D, Hosey J, Santos E, Halton E, Maslak P, Scheinberg D, Jurcic J, Heaney M, Heller G, Frattini M, Sadelain M. Safety and persistence of adoptively transferred autologous CD19-targeted T cells in patients with relapsed or chemotherapy refractory B-cell leukemias. Blood. 2011 Nov 3;118(18):4817-28. doi: 10.1182/blood-2011-04-348540. Epub 2011 Aug 17. |
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| Part B Screening |
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| Study Treatment |
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| 12-Month Follow-up Period |
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Total number of subjects who received at least one infusion of JCAR015
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| ID | Title | Description |
|---|---|---|
| BG000 | JCAR015 | Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Median | Full Range | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Time Since Diagnosis | Median | Full Range | years |
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| Number of Prior Lines of Therapy | Median | Full Range | lines of therapy |
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| Most Recent Prior Regimen | Count of Participants | Participants |
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| Response to Most Recent Prior Regimen | Count of Participants | Participants |
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| Prior Stem Cell Transplant | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group (ECOG) Score | 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair From Oken MM, et al. Am J Clin Oncol 1982;5(6):649-655. | Count of Participants | Participants |
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| Philadelphia Chromosome Status | The Philadelphia (Ph) chromosome is an abnormally short chromosome 22 that results from translocation between the BCR gene on chromosome 22 with the ABL gene on chromosome 9. The resulting BCR-ABL gene encodes a fusion protein with uncontrolled tyrosine kinase activity and has been linked to chronic myeloid leukemia and one form of ALL. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
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| Primary | Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematopoietic Recovery (CRi), as Determined by an Independent Review Committee (IRC) | Overall remission rate (ORR) is defined as the percentage of participants with CR or CRi based on IRC assessment. For CR, all of the following must be met: (1) in bone marrow, trilineage hematopoiesis and < 5% blasts; (2) in peripheral blood, neutrophils > 1,000/µL, platelets > 100,000/µL, and circulating blasts < 1%; (3) no clinical evidence of extramedullary disease by physical examination and no symptoms suggestive of CNS involvement (if additional assessments such as CSF assessment by lumbar puncture or Ommaya reservoir tap, CNS imaging, or biopsy are performed, results must show no evidence of disease); (4) no platelet and/or neutrophil transfusions ≤ 7 days before the date of peripheral blood sampling, and (5) no clinical evidence of recurrence for 4 weeks. For CRi, all criteria for CR are met except that one or more of the following exists in the peripheral blood: neutrophils ≤ 1,000/µL, platelets ≤ 100,000/µL, or platelet transfusions ≤ 7 days before blood sampling. | The analysis population includes participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one JCAR015 infusion, and who were evaluable for response (excludes 2 subjects with Grade 5 brain edema who died within 8 days after JCAR015 infusion). | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
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| Secondary | Percentage of Participants With CR or CRi, as Determined by an IRC | ORR is defined as the percentage of participants with CR or CRi based on IRC assessment (refer to criteria in Outcome Measure #1) | The analysis population includes participants with morphologic disease who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one JCAR015 infusion, and who were evaluable for response (excludes 5 subjects with Grade 5 brain edema who died within 8 days after JCAR015 infusion). | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
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| Secondary | Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC | Best overall response (BOR) is defined as the best disease response recorded from the time of the last JCAR015 infusion until the start of another anticancer therapy (refer to Outcome Measure #1 for criteria for CR and CRi). | The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015. | Posted | Number | percentage of participants | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
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| Secondary | Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC | BOR is defined as the best disease response recorded from the time of the last JCAR015 infusion until the start of another anticancer therapy (refer to Outcome Measure #1 for criteria for CR and CRi). | The analysis population includes all participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015. | Posted | Number | percentage of participants | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
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| Secondary | Percentage of Participants Who Achieved a Minimal Residual Disease (MRD)-Negative CR or CRi | Percentage of participants who achieved a CR or CRi, as determined by an IRC, with no evidence of MRD in the bone marrow (refer to Outcome Measure #1 for criteria for CR and CRi). MRD-negative is defined as undetectable leukemic cells in the bone marrow as determined by a polymerase chain reaction (PCR)-based assay. | The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015. | Posted | Number | percentage of participants | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
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| Secondary | Percentage of Participants Who Achieved a MRD-Negative CR or CRi | Percentage of participants who achieved a CR or CRi, as determined by an IRC, with no evidence of MRD in the bone marrow (refer to Outcome Measure #1 for criteria for CR and CRi). MRD-negative is defined as undetectable leukemic cells in the bone marrow as determined by a PCR-based assay. | The analysis population includes all participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015. | Posted | Number | percentage of participants | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
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| Secondary | Relapse-Free Survival (RFS), as Determined by an IRC | RFS is defined as the interval from the first documentation of CR or CRi (refer to Outcome Measure #1) to the earlier date of relapse or death due to any cause. Participants who proceeded to hematopoietic stem cell transplant (HSCT) after JCAR015 infusion were censored at the time of HSCT. | The analysis population includes participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015, and who achieved a CR or CRi after JCAR015 infusion. | Posted | Median | 95% Confidence Interval | months | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
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| Secondary | RFS, as Determined by an IRC | RFS is defined as the interval from the first documentation of CR or CRi (refer to Outcome Measure #1) to the earlier date of relapse or death due to any cause. Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT. | The analysis population includes participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015, and who achieved a CR or CRi after JCAR015 infusion. | Posted | Median | 95% Confidence Interval | months | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
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| Secondary | Event-Free Survival (EFS) | EFS is defined as the time from the date of the first JCAR015 infusion to the earliest of the following events: death from any cause, relapse, or treatment failure (defined as no response and subsequent discontinuation from the study for adverse event, lack of efficacy or progressive disease, or new anticancer therapy). Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT. | The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015. | Posted | Median | 95% Confidence Interval | months | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
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| Secondary | EFS | EFS is defined as the time from the date of the first JCAR015 infusion to the earliest of the following events: death from any cause, relapse, or treatment failure (defined as no response and subsequent discontinuation from the study for adverse event, lack of efficacy or progressive disease, or new anticancer therapy). Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT. | The analysis population includes all participants who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015. | Posted | Median | 95% Confidence Interval | months | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
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| Secondary | Overall Survival (OS) | OS is defined as the interval from the date of the first JCAR015 infusion to the date of death due to any reason. | The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015. | Posted | Median | 95% Confidence Interval | months | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
|
| ||||||||||||||||||||||||||
| Secondary | OS | OS is defined as the interval from the date of the first JCAR015 infusion to the date of death due to any reason. | The analysis population includes all participants who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015. | Posted | Median | 95% Confidence Interval | months | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Remission (DOR) as Determined by an IRC | DOR is defined as the interval from the first documentation of CR or CRi to the earlier date of relapse or death due to ALL. | The analysis population includes participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015, and who achieved a CR or CRi after JCAR015 infusion. | Posted | Median | 95% Confidence Interval | months | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC, at Month 6 After the Final JCAR015 Infusion | ORR at Month 6 is defined as the percentage of participants who achieved a CR or CRi at Month 6 after the final JCAR015 infusion without HSCT during the time period between the final JCAR015 infusion and the Month 6 response assessment (refer to Outcome Measure #1 for criteria for CR and CRi). | The analysis population includes all participants who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015. | Posted | Number | percentage of participants | Day 1 (first JCAR015 infusion) up to 6 months after the last JCAR015 infusion |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Morphologic Remission Within 6 Months After the Final JCAR015 Infusion and Then Proceeded to HSCT | Percentage of participants who achieved a morphologic remission within 6 months after the final JCAR015 infusion and then proceeded to HSCT prior to 12 months after the final JCAR015 infusion | The analysis population includes participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015, and who were evaluable for response. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion |
|
| ||||||||||||||||||||||||||
| Secondary | Maximum Concentration of JCAR015 (Cmax) in the Peripheral Blood by Quantitative Polymerase Chain Reaction (qPCR) | Cmax is defined as the highest measured number of copies of JCAR015 transgene per microgram of genomic DNA in peripheral blood cells as assessed by qPCR. | The analysis population includes all participants who received at least one infusion of JCAR015. | Posted | Median | Full Range | vector copy number/microgram | Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable) |
|
| ||||||||||||||||||||||||||
| Secondary | Maximum Concentration of JCAR015 (Cmax) in the Peripheral Blood by Flow Cytometry | Cmax is defined as the highest measured concentration of JCAR015 CAR T cells per microliter of peripheral blood as measured by flow cytometry. | The analysis population includes all participants who received at least one infusion of JCAR015. | Posted | Median | Full Range | cells/microliter | Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable) |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Maximum Concentration of JCAR015 (Tmax) in the Peripheral Blood as Measured by qPCR | Tmax is defined as the time after the JCAR015 infusion at which the maximum concentration (Cmax) as measured by qPCR is observed. If Cmax occurred after the second infusion, Tmax was calculated from the time of the second infusion. | The analysis population includes all participants who received at least one infusion of JCAR015. | Posted | Median | Full Range | days | Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable) |
|
| ||||||||||||||||||||||||||
| Secondary | Tmax in the Peripheral Blood as Measured by Flow Cytometry | Tmax is defined as the time after the JCAR015 infusion at which the Cmax as measured by flow cytometry of the JCAR015 CAR is observed. If Cmax occurred after the second infusion, Tmax was calculated from the time of the second infusion. | The analysis population includes all participants who received at least one infusion of JCAR015 and whose Cmax was >0. | Posted | Median | Full Range | days | Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable) |
|
| ||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-vs-Time Curve (AUC) for JCAR015 in the Peripheral Blood as Measured by qPCR | AUC is defined as the area under the concentration-vs-time curve from Day 1 to Day 29 after the first JCAR015 infusion as measured by qPCR of the JCAR015 transgene. AUC calculation includes pharmacokinetic (PK) results up to the second JCAR015 infusion for subjects who received the second infusion prior to Day 29 after the first JCAR015 infusion. | The analysis population includes all participants who received at least one infusion of JCAR015. | Posted | Median | Full Range | vector copy number*days/microgram | Pre-dose Day 1 of the first JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion |
|
| ||||||||||||||||||||||||||
| Secondary | AUC for JCAR015 in the Peripheral Blood as Measured by Flow Cytometry | AUC is defined as the area under the concentration-vs-time curve from Day 1 to Day 29 after the first JCAR015 infusion as measured by flow cytometry of the JCAR015 CAR. AUC calculation includes PK results up to the second JCAR015 infusion for subjects who received the second infusion prior to Day 29 after the first JCAR015 infusion. | The analysis population includes all participants who received at least one infusion of JCAR015. | Posted | Median | Full Range | cells*days/microliter | Pre-dose Day 1 of the first JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed Anti-Therapeutic Antibodies Against JCAR015 | Percentage of participants who developed anti-therapeutic antibodies against JCAR015 | The analysis population includes all enrolled subjects who underwent leukapheresis and had a sample that was evaluable for the assay. | Posted | Number | percentage of participants | Part B Screening; Day 14 after the first JCAR015 infusion; Pre-Dose Day 1 of the second JCAR015 infusion; Day 14 after the second JCAR015 infusion; and Day 28, Month 3, Month 6, and Month 12 after the last JCAR015 infusion |
|
|
From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion
The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JCAR015 | Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days. | 24 | 38 | 23 | 38 | 38 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Encephalopathy | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytokine release syndrome | Immune system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
Investigators have the right to publish and/or present study data after publication of the sponsor's multicenter study publication provided that the investigator shall (i) provide the sponsor a copy of any proposed publication or presentation generally thirty (30) days in advance of the submission; (ii) delete any confidential information of the sponsor; and (iii) delay submission for generally up to ninety (90) days to permit the sponsor to prepare and file intellectual property applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nikolaus Trede | Juno Therapeutics | 206-566-5886 | Nick.Trede@junotherapeutics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2016 | Apr 23, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Physician Decision |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| Change in diagnosis, no longer eligible |
|
| Subject received alternative therapy |
|
| Subject transferred to hospice |
|
| 65 or older |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Marqibo |
|
| Multi-agent chemotherapy |
|
| Tyrosine kinase inhibitor + chemotherapy |
|
| Tyrosine kinase inhibitor alone |
|
| Other |
|
| Not applicable |
|
| Missing |
|
| 2 |
|
| 3 |
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