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: 22 Jun 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

    • 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.
    • 12 Dec 2023 Results of a sub-group analysis assessing outcomes of patients in the blinatumomab arm of the trial who received all 4 cycles of blinatumomab compared to those who received 1-2 cycles presented at the 65th American Society of Hematology Annual Meeting and Exposition
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top