Clinical Trials /

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients

NCT02228096

Description:

This was a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell acute lymphoblastic leukemia, who were refractory to standard chemotherapy regimen or relapsed after allogeneic stem cell transplant.

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients
  • Official Title: A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia

Clinical Trial IDs

  • ORG STUDY ID: CCTL019B2205J
  • SECONDARY ID: 2015-003736-13
  • NCT ID: NCT02228096

Conditions

  • B-cell Acute Lymphoblastic Leukemia
  • Relapsed B-cell Acute Lymphoblastic Leukemia
  • Refractory B-cell Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
CTL019 T-cellstisagenlecleuceltisagenlecleucel (CTL019)

Purpose

This was a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell acute lymphoblastic leukemia, who were refractory to standard chemotherapy regimen or relapsed after allogeneic stem cell transplant.

Trial Arms

NameTypeDescriptionInterventions
tisagenlecleucel (CTL019)ExperimentalPediatric patients with relapsed/refractory B-cell ALL
  • CTL019 T-cells

Eligibility Criteria

        Inclusion Criteria:

          -  Relapsed or refractory pediatric B-cell ALL and lymphoblastic lymphoma:

               1. 2nd or greater Bone Marrow (BM) relapse OR

               2. Any BM relapse after allogeneic SCT and must be > 6 months from SCT at the time
                  of CTL019 infusion OR

               3. Refractory as defined by not achieving a CR after 2 cycles of a standard
                  chemotherapy regimen chemotherapy regimen or chemorefractory as defined by not
                  achieving a CR after 1 cycle of standard chemotherapy for relapse leukemia OR

               4. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are
                  intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI),
                  or if TKI therapy is contraindicated OR

               5. Ineligible for allogeneic SCT

          -  For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral
             blood by flow cytometry within 3 months of study entry

          -  Adequate organ function defined as:

               1. Renal function defined as (Calculated creatinine clearance or radioisotope
                  Glomerular Filtration Rate (GFR) > 60 mL/min/1.73 m2 OR serum creatinine based on
                  age/gender

               2. Alanine Aminotransferase (ALT) <= 5 times the upper limit of normal (ULN) for
                  age;

               3. Bilirubin < 2.0 mg/dL;

               4. Must have a minimum level of pulmonary reserve defined as ≤Grade 1 dyspnea and
                  pulse oxygenation > 91% on room air

               5. Left Ventricular Shortening Fraction (LVSF) ≥ 28% confirmed by echocardiogram, or
                  Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by echocardiogram or
                  MUGA within 7 days of screening

          -  Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening

          -  Life expectancy > 12 weeks

          -  Age 3 at the time of screening per protocol to age 21 at the time of initial diagnosis

          -  Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at
             screening

          -  Signed written informed consent and assent forms (if applicable) must be obtained
             prior to any study procedures

          -  Once all other eligibility criteria are confirmed, must have an apheresis product of
             non-mobilized cells received and accepted by the manufacturing site. Note: Apheresis
             product will not be shipped to or assessed for acceptance by the manufacturing site
             until documented confirmation of all other eligibility criteria is received.

          -  Patients with active CNS leukemia involvement defined as CNS-3 by CSF findings only
             are eligible but will have their CTL019 infusion delayed until CNS disease is reduced
             to CNS-1 or CNS-2 by CSF findings. Patients with other forms of active CNS-3 leukemic
             involvement such as CNS parenchymal or ocular disease, cranial nerve involvement or
             significant leptomeningeal disease are not eligible. However, such patients with other
             forms of CNS-3 leukemic involvement (non-CSF involvement) are eligible if there is
             documented evidence of disease stabilization for at least 3 months prior to CTL019
             infusion. Patients must have no acute/ongoing neurologic toxicity > Grade 1 with the
             exception of a history of controlled seizures or fixed neurologic deficits that have
             been stable/improving over the past 3 months.

        Exclusion Criteria:

          -  Isolated extra-medullary disease relapse

          -  Patients with concomitant genetic syndrome: such as patients with Fanconi anemia,
             Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome.
             Patients with Down Syndrome will not be excluded.

          -  Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL,
             leukemia with B-cell [surface Immunoglobulin (sIg) positive and kappa or lambda
             restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)

          -  Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative
             intent and with no evidence of active disease

          -  Prior treatment with gene therapy product

          -  Treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy

          -  Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)

          -  Patient has participated in an investigational research study using an investigational
             agent within the last 30 days prior to screening

          -  Pregnant or nursing (lactating) women. NOTE: female study participants of reproductive
             potential must have a negative serum or urine pregnancy test performed within 48 hours
             before infusion

          -  Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening),
             or any uncontrolled infection at screening

          -  HIV positive test within 8 weeks of screening

          -  The following medications are excluded:

               1. Steroids: Therapeutic systemic doses of steroids must be stopped > 72 hours prior
                  to CTL019 infusion. However, the following physiological replacement doses of
                  steroids are allowed: < 12 mg/m2/day hydrocortisone or equivalent

               2. Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be
                  completed > 6 weeks prior to CTL019 infusion

               3. GVHD therapies: Any systemic drug used for GVHD must be stopped > 4 weeks prior
                  to CTL019 infusion to confirm that GVHD recurrence is not observed (e.g.
                  calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolate,
                  rapamycin, thalidomide, or immunosuppressive antibodies such as anti-CD20
                  (rituximab), anti-tumor necrosis factor [anti-TNF], anti-interleukin 6 [anti-IL6]
                  or anti-interleukin 6 receptor [anti-IL6R], systemic steroids)

               4. Chemotherapy:

          -  Tyrosine kinase inhibitors and hydroxyurea must be stopped > 72 hours prior to CTL019
             infusion

          -  The following drugs must be stopped > 1 week prior to CTL019 infusion and should not
             be administered concomitantly or following lymphodepleting chemotherapy: vincristine,
             6-mercaptopurine, 6-thioguanine, methotrexate < 25 mg/m2, cytosine arabinoside < 100
             mg/m2/day, asparaginase (non-pegylated)

          -  The following drugs must be stopped >2 weeks prior to CTL019 infusion: salvage
             chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines,
             cyclophosphamide, methotrexate ≥ 25 mg/m2), excluding the required lymphodepleting
             chemotherapy drugs

          -  Pegylated-asparaginase must be stopped > 4 weeks prior to CTL019 infusion e. CNS
             disease prophylaxis:

          -  CNS prophylaxis treatment must be stopped > 1 week prior to CTL019 infusion (e.g.
             intrathecal methotrexate) f. Radiotherapy:

          -  Non-CNS site of radiation must be completed > 2 weeks prior to CTL019 infusion

          -  CNS directed radiation must be completed > 8 weeks prior to CTL019 infusion g. Anti
             T-cell Antibodies: Administration of any T cell lytic or toxic antibody (e.g.
             alemtuzumab) within 8 weeks prior to CTL019 is prohibited since residual lytic levels
             may destroy the infused CTL019 cells and/or prevent their in vivo expansion. If such
             an agent has been administered within 8 weeks prior to CTL019, contact the Sponsor,
             consider consultation with an pharmacology expert, and consider measuring residual
             drug levels, if feasible, prior to CTL019 infusion Women of child-bearing potential
             (defined as all women physiologically capable of becoming pregnant) and all male
             participants, unless they are using highly effective methods of contraception for a
             period of 1 year after the CTL019 infusion. Highly effective contraception methods
             include:

               1. Total abstinence (when this is in line with the preferred and usual lifestyle of
                  the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal,
                  post-ovulation methods) and withdrawal are NOT acceptable methods of
                  contraception

               2. Female sterilization (have had surgical bilateral oophorectomy with or without
                  hysterectomy), total hysterectomy, or tubal ligation at least six weeks before
                  taking study treatment. In case of oophorectomy alone, only when the reproductive
                  status of the woman has been confirmed by follow up hormone level assessment

               3. Male sterilization (at least 6 months prior to screening). For female patients on
                  the study the vasectomized male partner should be the sole partner for that
                  patient

               4. Use of oral, injected or implanted hormonal methods of contraception or other
                  forms of hormonal contraception that have comparable efficacy (failure rate <1%),
                  for example hormone vaginal ring or transdermal hormone contraception

               5. Use of IUDs are excluded due to increased risks of infection and bleeding in this
                  population. However, IUD inserted prior to consent may remain in place, and a
                  second method of contraception is mandated

               6. In case of use of oral contraception, women must be stable on the same pill for a
                  minimum of 3 months before taking study treatment.

        Women who are not of reproductive potential (defined as either <11 years of age, Tanner
        Stage 1, post-menopausal for at least 24 consecutive months (i.e. have had no menses) or
        have undergone hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) are
        eligible without requiring the use of contraception. Women who are not yet of reproductive
        potential are to agree to use acceptable forms of contraception when they reach
        reproductive potential if within 1 year of CTL019 or if CAR cells are present in the blood
        by PCR. Acceptable documentation includes written or oral documentation communicated by
        clinician or clinician's staff of one of the following:

          1. Demographics show age < 11

          2. Physical examination indicates Tanner Stage 1

          3. Physician report/letter

          4. Operative report or other source documentation in the patient record

          5. Discharge summary

          6. Follicle stimulating hormone measurement elevated into the menopausal range
      
Maximum Eligible Age:21 Years
Minimum Eligible Age:3 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Remission Rate (ORR) Per Independent Review Committee (IRC) (for ALL Participants)
Time Frame:within 6 months after CTL019 infusion
Safety Issue:
Description:ORR is defined as the percentage of participants with a best overall disease response of complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until the start of new anticancer therapy. Best response was assigned in the following order: CR, CRi, CR or CRi with residual mediastinal disease, No response and Unknown.

Secondary Outcome Measures

Measure:Percentage of Participants With Clinical Response Without Stem Cell Transplantation (SCT) at Month 6 - Per IRC Assessment
Time Frame:Month 6
Safety Issue:
Description:Evaluate the percentage of participants who achieved CR or CRi at Month 6 without SCT between tisagenlecleucel infusion and Month 6 response assessment.
Measure:Percentage of Subjects Who Achieved CR or CRi and Then Proceeded to SCT While in Remission Prior to Month 6 Response - Per IRC Assessment
Time Frame:prior to Month 6
Safety Issue:
Description:Evaluate the percentage of subjects who achieved CR or CRi and then proceeded to SCT while in remission prior to Month 6 response assessment.
Measure:Duration of Remission (DOR) Per Local and IRC Assessment
Time Frame:From CR or CRi to relapse or death up to 60 months
Safety Issue:
Description:DOR is the time from achievement of CR or CRi, whichever occurs first, to relapse or death due to ALL
Measure:Percentage of Participants With CR or CRi With Minimum Residual Disease (MRD) Negative Bone Marrow 6 Months After CTL019 Infusion
Time Frame:within 6 months
Safety Issue:
Description:Percentage of participants with best overall response (BOR) of CR or CRi with MRD negative bone marrow status 6 months after CTL019 infusion among all participants who achieved CR or CRi per Local Investigator & IRC assessment
Measure:Relapse-free Survival (RFS) for Responders Per Local and IRC Assessment
Time Frame:60 Months
Safety Issue:
Description:RFS is the time from achievement of CR or CRi whichever occurs first to relapse or death due to any cause during CR or CRi.
Measure:Event-free Survival (EFS) Per Local and IRC Assessment
Time Frame:60 Months
Safety Issue:
Description:EFS is the time from date of CTL019 infusion to the earliest of death, relapse or treatment failure. Treatment failure is defined as "no response" in the study and discontinuation from the study due to any of the following reasons: death, AE, lack of efficacy, new anticancer therapy.
Measure:Overall Survival (OS)
Time Frame:60 Months
Safety Issue:
Description:OS is the time from date of CTL019 infusion to the date of death due to any reason
Measure:Secondary Outcome: Percentage of Participants Attaining CR or CRi With MRD Negative Bone Marrow Status at Day 28 +/- 4 Days After CTL019 Infusion
Time Frame:Day 28
Safety Issue:
Description:Percentage of participants attaining CR or CRi with MRD negative bone marrow status at Day 28 +/- 4 days after CTL019 infusion per Local Investigator and IRC assessment. BM MRD were only collected and measured only within responders.
Measure:CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
Time Frame:Enrollment; D1; D4; D7; D11; D14; D21; D28; M3; M6; M9, M12; M18; M24, M30, M36, M42, M48 for transgene levels in blood; Screening, D28, M3, M6 for transgene levels in bone marrow
Safety Issue:
Description:Characterize the in vivo cellular pharmacokinetic (PK) profile (levels,persistence, trafficking) of CTL019 cells in target tissues
Measure:Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)
Time Frame:Baseline; Day 14; Day 28; Month 3; Month 6; Month 12; Month 24, Month 36
Safety Issue:
Description:Humoral immunogenicity was measured by anti-CTL019 antibodies in human serum using a flow cytometry method. (Prevalence and incidence of immunogenicity to CTL019)
Measure:ORR by Low Baseline Bone Marrow Burden Within 6 Months Post CTL019 Infusion
Time Frame:Within 6 months
Safety Issue:
Description:ORR within 6 months after infusion of CTL019 per Local & IRC assessment by baseline bone marrow tumor burden presence.
Measure:ORR by High Baseline Bone Marrow Burden Within 6 Months Post CTL019 Infusion
Time Frame:Within 6 months
Safety Issue:
Description:ORR within 6 months after infusion of CTL019 per Local Investigator & IRC assessment by high baseline bone marrow tumor burden presence.
Measure:ORR by Baseline Extramedullary Disease Presence of Yes Within 6 Months Post CTL019 Infusion
Time Frame:Within 6 months
Safety Issue:
Description:ORR within 6 months after infusion of CTL019 per Local Investigator & IRC assessment by baseline extramedullary disease presence of Yes.
Measure:ORR by Baseline Extramedullary Disease Presence of No Within 6 Months Post CTL019 Infusion
Time Frame:Within 6 months
Safety Issue:
Description:ORR within 6 months after infusion of CTL019 per Local Investigator & IRC assessment by baseline extramedullary disease presence of No.
Measure:Bone Marrow (BM) Minimum Residual Disease (MRD) Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by High Baseline Bone Marrow Tumor Burden
Time Frame:Within 6 months
Safety Issue:
Description:BM MRD status was by Local Investigator and IRC assessment within 6 months after infusion of CTL019 by baseline bone marrow tumor burden. BM MRD were collected and measured only within responders.
Measure:Bone Marrow MRD Status Was by Flow Cytometry Within 6 Months Post CTL019 Infusion by Low Baseline Bone Marrow Tumor Burden
Time Frame:Within 6 months
Safety Issue:
Description:BM MRD status was per Local Investigator and IRC assessment within 6 months after infusion of CTL019 by low baseline bone marrow tumor burden. BM MRD were collected and measured only within responders.
Measure:Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: Yes
Time Frame:Within 6 months
Safety Issue:
Description:BM MRD status was by Local Investigator and IRC assessment within 6 months after infusion pf CTL019 by baseline extramedullary disease presence of Yes. BM MRD were collected and measured only within responders.
Measure:Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: No
Time Frame:Within 6 months
Safety Issue:
Description:BM MRD status WAS per Local Investigator and IRC assessment within 6 months after infusion pf CTL019 by baseline extramedullary disease presence of No. BM MRD were collected and measured only within responders.
Measure:Duration of Remission (DoR) Censoring Hematopoietic Stem Cell Transplantation (HSCT) by Low Baseline Bone Marrow Tumor Burden
Time Frame:Within 6 months
Safety Issue:
Description:DoR per Local Investigator & IRC assessment by low baseline marrow tumor burden
Measure:Duration of Remission (DoR) Censoring HSCT by High Baseline Bone Marrow Tumor Burden
Time Frame:Within 6 months
Safety Issue:
Description:DoR per Local Investigator & IRC assessment by high baseline bone marrow tumor burden
Measure:Duration of Remission (DoR) Censoring HSCT by Baseline Extramedullary Disease Presence: Yes
Time Frame:Within 6 months
Safety Issue:
Description:DoR per Local Investigator & IRC assessment by baseline extramedullary disease presence of Yes.
Measure:Duration of Remission (DoR) Censoring HSCT by Baseline Extramedullary Disease Presence: No
Time Frame:Within 6 months
Safety Issue:
Description:DoR per Local Investigator & IRC assessment by baseline extramedullary disease presence of No
Measure:Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
Time Frame:Baseline; Day 14; Day 28; Month 3; Month 6; Month 12; Month 24, Month 36
Safety Issue:
Description:Activation of T cells in PBMC collected from subjects in response to mCAR19 -derived peptides was used to assess the cellular immunogenicity against tisagenlecleucel. CD4 and CD8 T cell net responses (in %) were calculated for 2 non-overlapping CTL019 peptide pools (i.e., Pool 1 and Pool 2). (Lymphocyte subsets of B and T cells and description of associated safety events)
Measure:Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: AUC0-28d and AUC0-84d
Time Frame:0 - 28 days post-infusion for AUC0-28d and 0 - 84 days post-infusion for AUC0-84d
Safety Issue:
Description:Characterize the in vivo cellular pharmacokinetic (PK) profile. AUC0-28d and AUC0-84d is defined as the AUC from time zero to day 28 and 84 or other disease assessment days, in peripheral blood (% or copies/μg x days). Data was only reported for evaluable PK parameters. The Overall Number of Participants Analyzed represents all participants for which a baseline assessment was collected for this Outcome Measure, and therefore these participants did contribute data to this estimation parameter, whereas the Number Analyzed per Row represents the number of participants with data available at either 28 or 84 days.
Measure:Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: Cmax
Time Frame:Day 28
Safety Issue:
Description:Characterize the in vivo cellular pharmacokinetic (PK) profile. Cmax is defined as the maximum (peak) observed in peripheral blood drug concentration after single dose administration (% or copies/μg).
Measure:Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: Tmax
Time Frame:Day 28
Safety Issue:
Description:Characterize the in vivo cellular pharmacokinetic (PK) profile. Tmax is defined as the time to reach maximum (peak) peripheral blood drug concentration after single dose administration (days)
Measure:Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: T1/2
Time Frame:Day 28
Safety Issue:
Description:Characterize the in vivo cellular pharmacokinetic (PK) profile. T1/2 is defined as the half-life associated with the disposition phase slopes (alpha, beta, gamma etc.) of a semi logarithmic concentration-time curve (days) in peripheral blood
Measure:Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: Clast
Time Frame:Day 28
Safety Issue:
Description:Characterize the in vivo cellular pharmacokinetic (PK) profile. Clast is defined as the last observed quantifiable concentration in peripheral blood (% or copies/ug)
Measure:Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: Tlast
Time Frame:Day 28
Safety Issue:
Description:Characterize the in vivo cellular pharmacokinetic (PK) profile. Tlast is defined as the time of last observed quantifiable concentration in peripheral blood (days)"
Measure:CD19 Status of Bone Marrow/Blood Relapse in FAS Patients Who Achieved CR or CRi and Then Relapsed
Time Frame:At time of relapse up to 60 months
Safety Issue:
Description:The CD19 status of bone marrow/blood relapse was categorized as follows: CD19 positive, CD19 dim, CD19 negative, CD19 positive/negative & CD19 unknown
Measure:Site of Initial Relapse Among FAS Patients Who Achieved CR/CRi and Then Relapsed
Time Frame:At time of relapse up to 60 months
Safety Issue:
Description:This is the site of involvement of initial relapse after achieving a best overall response of CR/CRi.
Measure:Time to B-cell Recovery in Participants Who Achieved CR or CRi by IRC
Time Frame:during the whole study, up to 60 months
Safety Issue:
Description:Time to B cell recovery was defined as the time from onset of remission to the earliest time when the percentage of CD19+ total B cell among viable WBC is ≥ 1% or among lymphocyte is at least 3%.
Measure:Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
Time Frame:Enrollment/Pre-Chemotherapy; Pre-infusion; Baseline; Day 7; Day 14; Day 21; Day 28; Month 3; Month 6; Month 9; Month 12; Month 24; Month 36
Safety Issue:
Description:The levels (%) of CD19+ total B cells amongst viable white blood cells (WBC) in peripheral blood
Measure:Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: C Reactive Protein (CRP)
Time Frame:Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3
Safety Issue:
Description:C-Reactive Protein at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3
Measure:Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Ferritin
Time Frame:Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3
Safety Issue:
Description:Ferritin at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3
Measure:Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: INF-gamma
Time Frame:Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3
Safety Issue:
Description:INF-gamma at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3
Measure:Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-6 (IL-6)
Time Frame:Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3
Safety Issue:
Description:IL-6 at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3
Measure:Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-2 (IL-2)
Time Frame:Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3
Safety Issue:
Description:IL-2 at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • relapsed/refractory
  • Philadelphia chromosome positive acute lymphoblastic leukemia
  • Pharmaceuticals
  • Philadelphia chromosome positive
  • Acute Lymphoid Leukemia (ALL)
  • Acute Lymphocytic Leukemia (ALL)
  • CTL019
  • tisagenlecleucel

Last Updated

November 23, 2020