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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-05

Study Completion Date

2026-01-07

Brief Summary

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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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Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tisagenlecleucel arm

Patient to receive tisagenlecleucel after optional bridging therapy and lymphodepleting chemotherapy.

Group Type EXPERIMENTAL

Tisagenlecleucel

Intervention Type BIOLOGICAL

autologous cellular immunotherapy product

Control arm

blinatumomab or inotuzumab per investigator's discretion after optional bridging chemotherapy

Group Type ACTIVE_COMPARATOR

Blinatumomab

Intervention Type DRUG

bispecific CD19-directed CD3 T-cell engager

Inotuzumab

Intervention Type DRUG

CD22-directed antibody-drug conjugate

Interventions

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Tisagenlecleucel

autologous cellular immunotherapy product

Intervention Type BIOLOGICAL

Blinatumomab

bispecific CD19-directed CD3 T-cell engager

Intervention Type DRUG

Inotuzumab

CD22-directed antibody-drug conjugate

Intervention Type DRUG

Other Intervention Names

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CTL019 KYMRIAH BLINCYTO BESPONSA Inotuzumab ozogamicin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No