Study of Inotuzumab Ozogamicin in Children and Young Adults w/CD22+ B-Acute Lymphoblastic Leukemia - Clinical Trial

What is the Purpose of this Study?

If you choose to join this study, you will:

  • Get 2-6 cycles of Inotuzumab Ozagamicin, lasting 1 month per cycle
  • Get Methotrexate on day one during cycle 1 and on day 28 of cycles 2, 4 and 6
  • Get about 3-5 mL of blood collected prior to treatment and at three time points during cycle 1 and 4 time points during cycle 2
What is the Condition Being Studied?

Children and young adults with Relapsed or or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

Who Can Participate in the Study?

Children and young adults who:

  • Are 1-22 years of age
  • Currently have or previously been diagnosed with B-Acute Lymphoblastic Leukemia (B-ALL)
  • Have recovered from any previous systemic therapy

For more information, contact the study team at diana.sedito@duke.edu.

Age Group
Adults, Children

What is Involved?

We are doing this study to find out what effects (good and/or bad) the study drug Inotuzumab Ozogamicin has on children and young adults with relapsed or refractory B-ALL.

Study Details

Full Title
AALL1621 A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND# 133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)
Principal Investigator
Pediatric Hematology-Oncology Specialist
Protocol Number
IRB: PRO00087382
NCT: NCT02981628
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate