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

Novartis

Status and phase: Withdrawn; Phase 3

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: Blinatumomab; Drug: Inotuzumab; Biological: Tisagenlecleucel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03628053

CCTL019I2301

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Tisagenlecleucel arm

Experimental group

Description:

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

Treatment:

Biological: Tisagenlecleucel

Control arm

Active Comparator group

Description:

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

Treatment:

Drug: Inotuzumab

Drug: Blinatumomab