Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults

Next Previous
X
Search
Trial Profile

A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Aug 2024

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Blinatumomab (Primary) ; Cyclophosphamide; Cyclophosphamide; Cytarabine; Cytarabine; Cytarabine; Daunorubicin; Dexamethasone; Etoposide; Mercaptopurine; Methotrexate; Methotrexate; Methotrexate; Pegaspargase; Pegaspargase; Prednisone; Rituximab; Vincristine
  • Indications Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 06 Aug 2024 According to an Amgen media release, data from this study published in the New England Journal of Medicine.
    • 14 Jun 2024 According to an Amgen media release, the U.S. Food and Drug Administration (FDA) has approved BLINCYTO (blinatumomab) for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status based on results form E1910 trial.
    • 06 Feb 2024 According to an Amgen media release, The FDA granted Priority Review for the Company's supplemental BLA for BLINCYTO in early-stage, CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) based in part on the Phase 3 E1910 study.Based on the Priority Review designation, the PDUFA date for BLINCYTO is June 21, 2024. Additional global regulatory authority submissions are underway.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top