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Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL) - Clinical Trial

What is the Purpose of this Study?

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

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 ages 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

Age Group
Adults, Children

What is Involved?

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

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
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698