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Monoclonal Antibodies

Inotuzumab + Blinatumomab for Acute Lymphoblastic Leukemia

Phase 2
Recruiting
Led By Matthew J Wieduwilt
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on World Health Organization (WHO) criteria. Patients with Burkitt lymphoma/leukemia are not eligible.
CD22-positive disease defined as CD22 expression by >= 20% of lymphoblasts by local hematopathology evaluation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing inotuzumab ozogamicin and blinatumomab to see if they can help treat patients with CD22-positive B-lineage acute lymphoblastic leukemia.

Who is the study for?
This trial is for patients with CD22-positive B-lineage acute lymphoblastic leukemia (ALL) that's new, returned, or resistant to treatment. Eligible participants must not have active central nervous system (CNS) leukemia and should be negative for the Philadelphia chromosome/BCR-ABL1. They need a bone marrow sample sent to HEME Biobank before joining.
What is being tested?
The study tests how well two monoclonal antibodies, inotuzumab ozogamicin and blinatumomab, treat ALL by helping the immune system attack cancer cells and preventing their growth. It's a phase II trial focusing on those who haven't responded well to previous treatments or are newly diagnosed.
What are the potential side effects?
Potential side effects of inotuzumab ozogamicin and blinatumomab may include allergic reactions, liver problems, low blood cell counts leading to increased infection risk or bleeding issues, fatigue, headache, fever, and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with precursor B-cell acute lymphoblastic leukemia, not Burkitt lymphoma.
Select...
My cancer cells show a high level of CD22.
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My leukemia does not have the Philadelphia chromosome.
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I have provided a bone marrow sample for analysis before joining the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-free survival
Secondary study objectives
Allogeneic hematopoietic cell transplantation rate (Cohort 2)
Complete and overall response rate
Event-free survival (EFS)
+2 more
Other study objectives
Cumulative incidence of relapse (CIR)
Non-relapse mortality
OS
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2 (inotuzumab ozogamicin, blinatumomab)Experimental Treatment2 Interventions
See Detailed Description.
Group II: Cohort 1 (inotuzumab ozogamicin, blinatumomab)Experimental Treatment2 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360
Blinatumomab
2014
Completed Phase 3
~1230

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,925 Previous Clinical Trials
41,017,937 Total Patients Enrolled
Matthew J WieduwiltPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
66 Total Patients Enrolled
~2 spots leftby Feb 2025
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