A Study of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Acute Lymphoblastic Leukemia (ALL)

  • STATUS
    Recruiting
  • End date
    Dec 20, 2022
  • participants needed
    21
  • sponsor
    Amgen
Updated on 18 March 2021
lymphoid leukemia
blinatumomab
dexamethasone

Summary

The primary objectives of this study are to evaluate the safety and tolerability of blinatumomab in combination with AMG 404 in adults with acute lymphoblastic leukemia (ALL) and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.

Details
Condition childhood ALL, Lymphocytic Leukemia, Acute, acute lymphoblastic leukemia, leukemia, acute lymphoblastic, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all)
Treatment Blinatumomab, AMG 404, Dexamethasone Premedication
Clinical Study IdentifierNCT04524455
SponsorAmgen
Last Modified on18 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 99 yrs?
Gender: Male or Female
Do you have any of these conditions: childhood ALL or Lymphocytic Leukemia, Acute?
Do you have any of these conditions: acute lymphoblastic leukemia (all) or childhood ALL or leukemia, acute lymphoblastic or acute lymphocytic leukemia or Lymphocytic Leukemia, Acute or a...?
Do you have any of these conditions: acute lymphoid leukaemia or Lymphocytic Leukemia, Acute or acute lymphoblastic leukemia or acute lymphoblastic leukemia (all) or childhood ALL or leuk...?
Do you have any of these conditions: acute lymphoblastic leukemia (all) or Lymphocytic Leukemia, Acute or acute lymphocytic leukemia or childhood ALL or acute lymphoid leukaemia or acute ...?
Do you have any of these conditions: acute lymphocytic leukemia or childhood ALL or leukemia, acute lymphoblastic or acute lymphoid leukaemia or Lymphocytic Leukemia, Acute or acute lymph...?
Do you have any of these conditions: childhood ALL or acute lymphoblastic leukemia (all) or leukemia, acute lymphoblastic or acute lymphocytic leukemia or Lymphocytic Leukemia, Acute or a...?
Do you have any of these conditions: acute lymphocytic leukemia or acute lymphoblastic leukemia or leukemia, acute lymphoblastic or acute lymphoid leukaemia or Lymphocytic Leukemia, Acute...?
Do you have any of these conditions: acute lymphocytic leukemia or childhood ALL or acute lymphoblastic leukemia (all) or acute lymphoid leukaemia or Lymphocytic Leukemia, Acute or acute ...?
Do you have any of these conditions: acute lymphoblastic leukemia (all) or acute lymphoid leukaemia or childhood ALL or acute lymphoblastic leukemia or leukemia, acute lymphoblastic or ac...?
Do you have any of these conditions: Lymphocytic Leukemia, Acute or acute lymphoblastic leukemia (all) or acute lymphoid leukaemia or acute lymphocytic leukemia or childhood ALL or leukem...?
Age 18 years at enrollment
Greater than or equal to 5% blasts in the bone marrow
Eastern Cooperative Oncology Group performance status (ECOG PS) 2
Negative pregnancy test in women of childbearing potential

Exclusion Criteria

Cancer chemotherapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy) within 21 days prior to study Day 1
Known hypersensitivity to blinatumomab or AMG 404 or to any component of the product formulation
Clear my responses

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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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