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Acute Lymphoblastic LeukemiaPhase 3OBERONNCT03628053

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

A Phase 3 study testing Tisagenlecleucel, Blinatumomab and Inotuzumab in people with Acute Lymphoblastic Leukemia, run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
Tisagenlecleucel, Blinatumomab and Inotuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
5 Jun 2020to 7 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Refractory to primary induction therapy
  • Refractory to first salvage therapy or
  • Relapse after allogenic stem cell transplant.

Who cannot join

  • 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.
  • Other protocol-defined Inclusion/Exclusion may apply.

About this study

Official title: 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.

Being tested
Tisagenlecleucel, Blinatumomab, Inotuzumab
Keywords
Acute lymphoblastic leukemia, tisagenlecleucel, intouzumab, blinatumomab, CAR-T, CTL019
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TisagenlecleucelBiological

    Also called CTL019, KYMRIAH

    autologous cellular immunotherapy product

  • BlinatumomabDrug

    Also called BLINCYTO

    bispecific CD19-directed CD3 T-cell engager

  • InotuzumabDrug

    Also called BESPONSA, Inotuzumab ozogamicin

    CD22-directed antibody-drug conjugate

Study groups in NCT03628053
Study groupRoleWhat they receive
Tisagenlecleucel armExperimentalPatient to receive tisagenlecleucel after optional bridging therapy and lymphodepleting chemotherapy.
Receives: Biological: Tisagenlecleucel
Control armActive comparatorblinatumomab or inotuzumab per investigator's discretion after optional bridging chemotherapy
Receives: Drug: Blinatumomab; Drug: Inotuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Time from randomization to death for any reason

    Measured: 4 years

Secondary outcomes (15)

  1. Event Free Survival (EFS)

    EFS, assessed up to 48 months, is defined as the date from randomization to the earliest of (a) date of death due to any cause, (b) relapse after CR/CRi, or (c) treatment failure, which is defined as failure to achieve remission within 12 weeks of randomization.

    Measured: 4 years

  2. Percentage of patients who achieved MRD negative CR/CRi

    Percentage of patients who achieved MRD negative CR/CRi at month 3 post randomization

    Measured: 4 years

  3. Overall response rate

    ORR is defined as the proportion of subjects with best overall response (BOR) of CR or CRi, where the BOR is defined as the best response recorded from randomization until the start of new anticancer therapy or the data cut-off date, whichever is earlier

    Measured: 4 years

  4. Duration of response (DOR)

    DOR is defined as the duration from the date when the response criteria of CR/CRi is first met to the date of relapse or death due to underlying cancer.

    Measured: 4 years

  5. Probability of patients who achieved CR/CRi at month 12

    Probability of achieving CR/CRi based on all response assessments between randomization and month 12. This outcome measure will be based on all randomized patients and the assessment will be up to 48 months (from randomization of the first patient until 12 months after the randomization of the last patient).

    Measured: 4 years

  6. Prevalence of immunogenecity

    Percentage of patients who have anti-tisagenlecleucel antibodies in the serum before randomization

    Measured: 4 years

  7. Incidence of immunogenecity

    Percentage of patients who develop anti-tisagenlecleucel antibodies in the serum after infusion of tisagenlecleucel

    Measured: 4 years

  8. Impact of immunogenicity on clinical response

    difference in response between patients with immunogenicity and patients without immunogenicity

    Measured: 4 years

  9. Cellular kinetic profile by qPCR

    Summary of qPCR detected tisagenlecleucel transgene concentrations

    Measured: 4 years

  10. Cellular kinetics profile by flow cytometry

    Summary of flow cytometry-detected tisagenlecleucel transgene concentrations

    Measured: 4 years

  11. Relationship between dose and response

    Relationship between the administered dose of tisagenlecleucel and response to treatment (complete response with or without hematological recovery). This assessment will be done for all patients for up to 48 months.

    Measured: 4 years

  12. Relationship between exposure and response

    Describe the relationship between the cellular kinetics of tisagenlecleucel overtime and response.

    Measured: 4 years

  13. Relationship between dose and cellular kinetic

    Describe the relationship between the dose of tisagenlecleucel actually administered and cellular kinetics

    Measured: 4 years

  14. EQ-5D-3L

    Patient reported outcome measure

    Measured: 4 years

  15. EORTC QLQ-30

    Patient reported outcome measure

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2018
  2. Study start5 Jun 2020 (estimated)
  3. Primary completion8 Oct 2025 (estimated)
  4. Study completion7 Jan 2026 (estimated)

Why it stopped: Novartis is no longer pursuing this study because of planned investigation of novel CAR-T therapies in this patient population.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03628053
Sponsor's protocol ID
CCTL019I2301
Acronym
OBERON
Status last verified
Jul 2020
First submitted
28 Jun 2018
Last updated
9 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tisagenlecleucel, Blinatumomab and Inotuzumab in people with Acute Lymphoblastic Leukemia, run by Novartis Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03628053.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.

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