A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)
This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment.
The purpose of this study is to determine the morphologic response rate (complete response [CR] + complete response with incomplete hematologic recovery [CRi]) following one cycle of treatment with inotuzumab ozogamicin (InO) in children with relapsed or refractory CD22+ B acute lymphoblastic leukemia (B-ALL).
You may be eligible for this study if you meet the following criteria:
- Conditions: leukemia
Age: Between 1 Years - 21 Years
Gender: Male or Female
Patients must have B-ALL with >= 5% (M2 or M3) bone marrow blasts with or without extramedullary disease
Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample; (assessment of CD22 using a phycoerythrin [PE] fluorophore is strongly recommended)
In the case of an inadequate aspirate sample (dry tap), flow cytometry of peripheral blood specimen may be substituted if the patient has at least 1000/uL circulating blasts; alternatively, CD22 expression may be documented by immunohistochemistry of a bone marrow biopsy specimen
Patient must have one of the following:
Second or greater relapse
Primary refractory disease with at least 2 prior induction attempts
First or greater relapse refractory to at least one prior re-induction attempt
Relapsed patients previously diagnosed with B-lymphoblastic lymphoma are eligible if they have an M2 or M3 marrow at the time of enrollment on this study
Patients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs)
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to = grade 2 or lower per the inclusion/exclusion criteria prior to entering this study
Patients with any prior history of SOS/VOD irrespective of severity
Patients with isolated central nervous system (CNS), testicular, or other extramedullary site of relapse
Patients who have been previously treated with InO
Patients with active optic nerve and/or retinal involvement that would require urgent radiation therapy concurrent with protocol therapy; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to assess optic nerve or retinal involvement
Patients who are currently receiving another investigational drug
Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy and intrathecal chemotherapy)
Anti-GVHD or agents to prevent organ rejection post-transplant; patients who are receiving cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial; at least 3 half-lives must have elapsed after the last dose of GVHD medications (meds)
Patients who are currently receiving or plan to receive corticosteroids except as described below
Systemic corticosteroids may be administered for cytoreduction up to 24 hours prior to the start of protocol therapy, as a premedication for InO and as treatment for allergic reactions or for physiologic replacement/stress dosing of hydrocortisone for documented adrenal insufficiency; corticosteroids are not allowed for other indications
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study
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