Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

— OBERON  

Official title:

Tisagenlecleucel Versus Blinatumomab or Inotuzumab for Adult Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia: A Randomized Open Label, Multicenter, Phase III Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03628053
• Other study ID #: CCTL019I2301
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 5, 2020
• Est. completion date: January 7, 2026

Study information

• Verified date: July 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 7, 2026
• Est. primary completion date: October 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed informed consent.

2. Age = 18 years.

3. Subject with CD19-expressing B-ALL.

4. Adequate organ function.

5. Patients considered in any of the following settings are eligible:

1. Untreated first or second relapse

2. Refractory to primary induction therapy

3. Refractory to first salvage therapy or

4. Relapse after allogenic stem cell transplant.

Exclusion Criteria:

1. Patients presenting with untreated first relapse of ALL more than 24 months after initial diagnosis

2. Presence of extra-medullary disease.

3. History or presence of clinically relevant CNS pathology, or uncontrolled CNS leukemia.

4. History of Veno-occlusive Disease (VOD).

5. Active neurological autoimmune or inflammatory disorders.

6. Active acute Graft-versus-Host Disease (GvHD), grade 2-4.

Other protocol-defined Inclusion/Exclusion may apply.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• Tisagenlecleucel
autologous cellular immunotherapy product

Drug:
• Blinatumomab
bispecific CD19-directed CD3 T-cell engager
• Inotuzumab
CD22-directed antibody-drug conjugate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Time from randomization to death for any reason	4 years
Secondary	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
Secondary	Percentage of patients who achieved MRD negative CR/CRi	Percentage of patients who achieved MRD negative CR/CRi at month 3 post randomization	4 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Prevalence of immunogenecity	Percentage of patients who have anti-tisagenlecleucel antibodies in the serum before randomization	4 years
Secondary	Incidence of immunogenecity	Percentage of patients who develop anti-tisagenlecleucel antibodies in the serum after infusion of tisagenlecleucel	4 years
Secondary	Impact of immunogenicity on clinical response	difference in response between patients with immunogenicity and patients without immunogenicity	4 years
Secondary	Cellular kinetic profile by qPCR	Summary of qPCR detected tisagenlecleucel transgene concentrations	4 years
Secondary	Cellular kinetics profile by flow cytometry	Summary of flow cytometry-detected tisagenlecleucel transgene concentrations	4 years
Secondary	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
Secondary	Relationship between exposure and response	Describe the relationship between the cellular kinetics of tisagenlecleucel overtime and response.	4 years
Secondary	Relationship between dose and cellular kinetic	Describe the relationship between the dose of tisagenlecleucel actually administered and cellular kinetics	4 years
Secondary	EQ-5D-3L	Patient reported outcome measure	4 years
Secondary	EORTC QLQ-30	Patient reported outcome measure	4 years