Purpose of this Study
If you choose to join this study, you will:<ul>
<li>Get 2-6 cycles of Inotuzumab Ozagamicin, lasting 1 month per cycle</li>
<li>Get Methotrexate on day one during cycle 1 and on day 28 of cycles 2, 4 and 6</li>
<li>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</li></ul>
<li>Get 2-6 cycles of Inotuzumab Ozagamicin, lasting 1 month per cycle</li>
<li>Get Methotrexate on day one during cycle 1 and on day 28 of cycles 2, 4 and 6</li>
<li>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</li></ul>
Who Can Participate?
Eligibility
Children and young adults who:<ul>
<li>Are 1-22 years of age</li>
<li>Currently have or previously been diagnosed with B-Acute Lymphoblastic Leukemia (B-ALL)</li>
<li>Have recovered from any previous systemic therapy</li></ul>
For more information, contact the study team at <a href= "mailto: diana.sedito@duke.edu">diana.sedito@duke.edu.</a>
<li>Are 1-22 years of age</li>
<li>Currently have or previously been diagnosed with B-Acute Lymphoblastic Leukemia (B-ALL)</li>
<li>Have recovered from any previous systemic therapy</li></ul>
For more information, contact the study team at <a href= "mailto: diana.sedito@duke.edu">diana.sedito@duke.edu.</a>
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
Jessica
Sun
Protocol Number
PRO00087382
NCT ID
NCT02981628
Phase
II
Enrollment Status
Open to Enrollment