← Back to Search

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
Patients may receive the day 1 of course IA dose of intrathecal (IT) methotrexate during the prior-to-registration lumbar puncture (or the venous line placement) to avoid a second lumbar puncture. If the dose is administered prior to registration, then systemic chemotherapy must begin within 7 days of this IT chemotherapy.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 received a specific spinal injection before joining the trial and started chemotherapy within 7 days after that.
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.
Select...
My leukemia does not have the Philadelphia chromosome.
Select...
I have provided a bone marrow sample for analysis before joining the study.
Select...
I do not have active leukemia in my brain or spinal cord.

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

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

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
Blinatumomab
2014
Completed Phase 3
~1150
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,277 Total Patients Enrolled
Matthew J WieduwiltPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
66 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks are associated with Inotuzumab Ozogamicin treatment?

"With the limited clinical data available, inotuzumab ozogamicin was assessed a safety score of 2 out of 3. Since this is only a phase two trial, there are no records yet indicating its efficacy."

Answered by AI

How many participants are accepted for this medical experiment?

"This study requires 64 volunteers that meet the outlined inclusion criteria. These participants can be found at Clackamas Radiation Oncology Center in Oregon and Marshfield Medical Centre-Rice Lake in Michigan."

Answered by AI

Are there any available opportunities for people to participate in this experiment?

"According to the records on clinicaltrials.gov, this research effort is in need of participants. It was initially announced November 16th 2018 and had a recent update November 30th 2022."

Answered by AI

How many distinct sites are involved in the execution of this experiment?

"This study is currently enrolling patients from 81 different sites, ranging from Clackamas to Rice Lake and Madison. To lessen the burden of travel costs, it may be prudent to select a site nearby your own location before signing up for this trial."

Answered by AI

Has Inotuzumab Ozogamicin been subject to any prior scientific testing?

"Inotuzumab Ozogamicin was initially trialled in 2011 at M D Anderson Cancer Center and has since been studied 38 times. Currently, 62 trials of this medication are being conducted across the world with a significant number hosted by Clackamas, Oregon."

Answered by AI

What indications are generally associated with Inotuzumab Ozogamicin?

"Inotuzumab Ozogamicin is employed to treat cases of refractory b-cell precursor acute lymphoblastic leukemia and relapsed b cell precursor acute lymphoblastic leukaemia. It may also be utilized in the context of kidney or heart transplantation."

Answered by AI
~9 spots leftby Feb 2025