A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients

  • STATUS
    Recruiting
  • End date
    Jun 16, 2024
  • participants needed
    35
  • sponsor
    Amgen
Updated on 11 June 2021

Summary

The study aims to evaluate the safety 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.

Details
Condition B Cell Precursor Acute Lymphoblastic Leukemia
Treatment Blinatumomab
Clinical Study IdentifierNCT04521231
SponsorAmgen
Last Modified on11 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 18 years or older
Participants with B-ALL with Relapsed or Refractory disease after at least 2 cycles of chemotherapy
Relapsed or Refractory at any time after first salvage therapy or refractory relapse
Relapse at any time after hematopoietic stem cell transplant (HSCT)
Greater than 5% blasts in the bone marrow
Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2
Participants with relapse or refractory B Cell ALL Ph+ disease and that are intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible
Negative pregnancy test in women of childbearing potential

Exclusion Criteria

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
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
Cancer chemotherapy within 2 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
Female participant: Expected to breastfeed during treatment and for 96 hours after the last dose of treatment
Clear my responses

How to participate?

Step 1 Connect with a site
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
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

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

Loading...

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 • 

 • 

Private

Reply by • Private
Loading...

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.
Loading...

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