A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

  • End date
    May 7, 2025
  • participants needed
  • sponsor
Updated on 14 October 2022


The study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Acute Lymphoblastic Leukemia (ALL) and to determine the maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) of SC administered blinatumomab.

Condition B Cell Precursor Acute Lymphoblastic Leukemia
Treatment Blinatumomab
Clinical Study IdentifierNCT04521231
Last Modified on14 October 2022


Yes No Not Sure

Inclusion Criteria

Aged 18 years or older
Participants with B-precursor ALL with any of the following
Either refractory to primary induction therapy or refractory to first, second, third, or more than third salvage therapy OR
In untreated first, second, third or greater relapse or refractory relapse
First Relapse is defined as achievement of first Complete Remission (CR) [CR1] during upfront therapy then relapse during or after continuation therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2
Primary Refractory disease is defined as the absence of CR after standard induction therapy
Participants with relapse or refractory B Cell ALL Ph+ disease and that are intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible
Second relapse or later relapse is defined as relapse after achieving a second CR (CR2) in first or later salvage
Refractory relapse is defined as lack of CR after salvage treatment
Refractory to salvage is defined as no attainment of CR after salvage
Relapsed or Refractory at any time after first salvage therapy
Relapse at any time after allogenic hematopoietic stem cell transplant (HSCT)
Greater than or equal to 5% blasts in the Bone Marrow
The above is a summary, other inclusion criteria details may apply

Exclusion Criteria

History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis
History of malignancy (with certain exceptions) other than ALL within 3 years prior to start of protocol-specified therapy
Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy
Immunotherapy within 4 weeks before start of protocol-specified therapy. Prior failed CD19 directed therapy such as prior blinatumomab or CD19 CAR T cells will be allowed, if treatment ended more than 4 weeks prior to start of protocol therapy
Currently receiving treatment in, or less than 30 days since ending treatment on another investigational study(ies)
Abnormal screening laboratory parameters
Active ALL in the central nervous system (CNS). Presence of greater than 5 white blood cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present and/or clinical signs of CNS leukemia
Female participant: Expected to breastfeed during treatment and for 96 hours after the last dose of treatment
Symptoms and/or signs that indicate an acute or uncontrolled chronic infection, any other disease or condition that could be exacerbated by the treatment or would complicate protocol compliance
Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy (with certain exceptions)
The above is a summary, other exclusion criteria details may apply
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note