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

  • Interventional
  • Not Recruiting
  • NCT03628053
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT03628053

IRB#IRB18-1455

Lead SponsorNovartis Pharmaceuticals

Lead PhysicianSatyajit Kosuri

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting