At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of B lymphoblastic leukemia (B-ALL)
- ✓At least 25% CD22 expression on immunophenotyping
- ✓Marrow relapse (M3 bone marrow) with or without extramedullary disease
- ✓First or later marrow relapse at any time after initial diagnosis, OR first/early marrow relapse <36 months from initial diagnosis
- ✕Down syndrome
- ✕B-cell L3 morphology or MYC translocation
- ✕Active or uncontrolled infection
- ✕Concurrent immunotherapy, biologic therapy, chemotherapy, radiotherapy, or other investigational drugs
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Feasibility Pilot and Phase II Study Of Chemoimmunotherapy With Epratuzumab (IND #12034) for Children With Relapsed CD22-Positive Acute Lymphoblastic Leukemia (ALL)
In Brief
A Phase 2 clinical trial evaluating L-asparaginase, doxorubicin hydrochloride, and 12 other interventions for Recurrent Childhood Acute Lymphoblastic Leukemia. Completed, enrolled 134 participants across 46 sites in 4 countries.
Detailed Summary
This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them or by stopping them from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer cells more effectively.
Study Details
Timeline
Interventions
Given IM
Given IV
40 mg/m2/day PO divided BID or TID
Given IV
Given IV
Given IT
Given orally
Given IM
Given IV
Given IT
Given IV
Given IV
Given IV
Given SC