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Novartis is no longer pursuing this study because of planned investigation of novel CAR-T therapies in this patient population.
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This trial aims to compare the benefits and risks of tisagenlecleucel to blinatumomab or inotuzumab in adult patients with relapsed or refractory ALL. This trial investigates tisagenlecleucel as an additional treatment option for this patient population with high unmet medical need.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tisagenlecleucel arm | Experimental | Patient to receive tisagenlecleucel after optional bridging therapy and lymphodepleting chemotherapy. |
|
| Control arm | Active Comparator | blinatumomab or inotuzumab per investigator's discretion after optional bridging chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tisagenlecleucel | Biological | autologous cellular immunotherapy product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time from randomization to death for any reason | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival (EFS) | EFS, assessed up to 48 months, is defined as the date from randomization to the earliest of (a) date of death due to any cause, (b) relapse after CR/CRi, or (c) treatment failure, which is defined as failure to achieve remission within 12 weeks of randomization. | 4 years |
| Percentage of patients who achieved MRD negative CR/CRi |
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Inclusion Criteria:
Signed informed consent.
Age ≥ 18 years.
Subject with CD19-expressing B-ALL.
Adequate organ function.
Patients considered in any of the following settings are eligible:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000626284 | tisagenlecleucel |
| C510808 | blinatumomab |
| D000080045 | Inotuzumab Ozogamicin |
| ID | Term |
|---|---|
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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This is a phase III, open label, multinational, randomized trial. Eligible patients will be randomized 1:1 to Tisagenlecleucel treatment strategy (tisagenlecleucel after optional bridging chemotherapy and lymphodepleting chemotherapy) or control arm treatment strategy (blinatumomab or inotuzumab per investigator's discretion after optional bridging chemotherapy).
The randomization will be performed stratifying for the number of prior salvage therapies (0 vs. 1) and prior allogenic stem cell transplant (yes vs. no).
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| Blinatumomab | Drug | bispecific CD19-directed CD3 T-cell engager |
|
|
| Inotuzumab | Drug | CD22-directed antibody-drug conjugate |
|
|
Percentage of patients who achieved MRD negative CR/CRi at month 3 post randomization |
| 4 years |
| Overall response rate | ORR is defined as the proportion of subjects with best overall response (BOR) of CR or CRi, where the BOR is defined as the best response recorded from randomization until the start of new anticancer therapy or the data cut-off date, whichever is earlier | 4 years |
| Duration of response (DOR) | DOR is defined as the duration from the date when the response criteria of CR/CRi is first met to the date of relapse or death due to underlying cancer. | 4 years |
| Probability of patients who achieved CR/CRi at month 12 | Probability of achieving CR/CRi based on all response assessments between randomization and month 12. This outcome measure will be based on all randomized patients and the assessment will be up to 48 months (from randomization of the first patient until 12 months after the randomization of the last patient). | 4 years |
| Prevalence of immunogenecity | Percentage of patients who have anti-tisagenlecleucel antibodies in the serum before randomization | 4 years |
| Incidence of immunogenecity | Percentage of patients who develop anti-tisagenlecleucel antibodies in the serum after infusion of tisagenlecleucel | 4 years |
| Impact of immunogenicity on clinical response | difference in response between patients with immunogenicity and patients without immunogenicity | 4 years |
| Cellular kinetic profile by qPCR | Summary of qPCR detected tisagenlecleucel transgene concentrations | 4 years |
| Cellular kinetics profile by flow cytometry | Summary of flow cytometry-detected tisagenlecleucel transgene concentrations | 4 years |
| Relationship between dose and response | Relationship between the administered dose of tisagenlecleucel and response to treatment (complete response with or without hematological recovery). This assessment will be done for all patients for up to 48 months. | 4 years |
| Relationship between exposure and response | Describe the relationship between the cellular kinetics of tisagenlecleucel overtime and response. | 4 years |
| Relationship between dose and cellular kinetic | Describe the relationship between the dose of tisagenlecleucel actually administered and cellular kinetics | 4 years |
| EQ-5D-3L | Patient reported outcome measure | 4 years |
| EORTC QLQ-30 | Patient reported outcome measure | 4 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D061067 |
| Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |