Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia

  • STATUS
    Recruiting
  • End date
    Aug 29, 2030
  • participants needed
    287
  • sponsor
    Amgen
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Updated on 8 April 2023
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Summary

The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.

Details
Condition Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Treatment Blinatumomab, Low-intensity chemotherapy regimen, SOC chemotherapy regimen
Clinical Study IdentifierNCT04994717
SponsorAmgen
Last Modified on8 April 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age ≥ 55 years at the time of informed consent. OR
Age 40 to < 55 years of age if at least 1 of the following comorbidities at the time of
informed consent
history of grades 3 and 4 pancreatitis
diabetes mellitus with end-organ damage
severe liver disease such as cirrhosis stage 2 with portal hypertension or history of
esophageal variceal bleeding and aspartate transaminase (AST)/alanine aminotransferase
(ALT) > 10 x upper limit of normal (ULN) (liver cirrhosis must be confirmed by biopsy)
body mass index (BMI) ≥ 40 combined with relevant comorbidities such as metabolic
syndrome
All participants must have adequate organ function as defined below
Any further combination of documented severe comorbidities that the investigator
judges to be incompatible with administering an intensive pediatric based, adult
adapted standard chemotherapy regimen but still compatible with the suggested protocol
for older participants in both the experimental and the SOC arm. The participant
history will be reviewed by the medical monitor during screening to determine
enrollment acceptability based on a standard list with types of comorbidities allowed
A medical advisory board is available to the investigators for questions/advice and
includes experts in the field of adult leukemia with experience with the use of
blinatumomab, the global development lead for blinatumomab and the medical monitor of
the study
Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor
acute lymphoblastic leukemia (ALL)
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, higher ECOG
score allowed if due to underlying leukemia
renal: estimated glomerular filtration rate based on MDRD calculation ≥ 50 mL/min/1.73
m^2
liver function: total bilirubin ≤ 2x upper limit of normal (ULN; unless Gilbert's
Disease or if liver involvement with leukemia); exception for participants 40 to < 55
years of age if they have a comorbidity listed above: severe liver disease such as
cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding
and AST/ALT > 10 x ULN (liver cirrhosis must be confirmed by biopsy)
cardiac: left ventricular ejection fraction (LVEF) ≥ 50%

Exclusion Criteria

Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy)
Known infection with human immunodeficiency virus (HIV)
Active hepatitis B and C based on the following results
Active central nervous system (CNS) leukemia not resolved with IT chemotherapy during
screening
Current autoimmune disease or history of autoimmune disease with potential CNS
involvement
Known infection with chronic or active infection with hepatitis B (eg, hepatitis b
surface [HBs] antigen reactive or quantifiable hepatitis b virus [HBV] viral load) or
hepatitis C virus (HCV) (eg, HCV RNA [qualitative] is detected)
positive for hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B
or recent acute hepatitis B)
negative HepBsAg and positive for hepatitis B core antibody: negative HBV DNA by PCR
result is necessary to enroll
positive Hepatitis C virus antibody (HepCAb): negative hepatitis C virus RNA by PCR
result is necessary to enroll
Participant with symptoms and/or clinical signs and/or radiographic and/or
sonographic signs that indicate an acute or uncontrolled chronic infection
Cancer chemotherapy for this newly diagnosed B cell ALL before the start of
protocol-required therapy with the exception of IT chemotherapy or pre-phase
chemotherapy. Radiation to a spot lesion such as chloroma or lytic lesion of bone
or vertebrae for pain or vertebral stabilization is allowed
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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.

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

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