NCT03628053WithdrawnPhase 3
Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia
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
Source: ClinicalTrials.gov · Last updated 9 Jul 2020
Reason given: Novartis is no longer pursuing this study because of planned investigation of novel CAR-T therapies in this patient population.
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 28 Jun 2018
- Start date
- 5 Jun 2020
- Primary completion date
- 8 Oct 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT03628053
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of extra-medullary disease.
- History of Veno-occlusive Disease (VOD).
- Active neurological autoimmune or inflammatory disorders.
- Active acute Graft-versus-Host Disease (GvHD), grade 2-4.
- Other protocol-defined Inclusion/Exclusion may apply.
Other
- Patients presenting with untreated first relapse of ALL more than 24 months after initial diagnosis
- History or presence of clinically relevant CNS pathology, or uncontrolled CNS leukemia.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.