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

Status: In Review

Description

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.

Eligibility Criteria

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:
  • Untreated first or second relapse
  • Refractory to primary induction therapy
  • Refractory to first salvage therapy or
  • Relapse after allogenic stem cell transplant.

Exclusion Criteria

  • Patients presenting with untreated first relapse of ALL more than 24 months after initial diagnosis
  • Presence of extra-medullary disease.
  • History or presence of clinically relevant CNS pathology, or uncontrolled CNS leukemia.
  • History of Veno-occlusive Disease (VOD).
  • Active neurological autoimmune or inflammatory disorders.
  • Active acute Graft-versus-Host Disease (GvHD), grade 2-4.

Locations & Contacts

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: In review
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Novartis Pharmaceuticals Corporation

Trial IDs

Primary ID CCTL019I2301
Secondary IDs NCI-2019-01059
Clinicaltrials.gov ID NCT03628053