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Monoclonal Antibodies

Blinatumomab + Inotuzumab Ozogamicin + Chemotherapy for Leukemia

Phase 2
Recruiting
Led By Elias Jabbour
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Performance status of 0-3
No active or co-existing malignancy with life expectancy less than 12 months, sources for the determination of clinical significance by the treating physician will be included in the subject's medical record
Must not have
Subjects who weigh less than 45 kg
Current autoimmune disease or history of autoimmune disease with potential CNS involvement; auto-immune disease with possible CNS consequences/manifestations such as such as epilepsy, paresis, aphasia, stroke, dementia, Parkinson's disease, cerebellar disease, or psychosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Approved for 60 Other Conditions
No Placebo-Only Group

Summary

This trial studies different therapies to treat B acute lymphoblastic leukemia, which may work better than chemotherapy alone.

Who is the study for?
This trial is for patients with newly diagnosed B acute lymphoblastic leukemia or those who've achieved remission after one chemotherapy course. Eligible participants must have a performance status of 0-3, creatinine ≤2.0 mg/dL, bilirubin ≤2.0 mg/dL, and adequate cardiac function. Exclusions include HIV-positive individuals, active uncontrolled diseases/infections, CNS pathology like epilepsy or stroke, current autoimmune disease with potential CNS involvement, pregnant/nursing women, Philadelphia chromosome-positive ALL.
What is being tested?
The study tests blinatumomab and inotuzumab ozogamicin combined with chemotherapy drugs (cyclophosphamide to prednisone) as initial treatment for B acute lymphoblastic leukemia. Blinatumomab modifies the immune system to target cancer cells; inotuzumab ozogamicin delivers toxins directly to cancer cells via CD22 binding.
What are the potential side effects?
Potential side effects may include immune system changes leading to inflammation in various organs; reactions at infusion sites; general fatigue; digestive issues such as nausea and vomiting; blood disorders including low counts of different types of blood cells which can increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do heavy physical work.
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I don't have another cancer that could shorten my life within a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I weigh less than 45 kg.
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I have an autoimmune disease that affects my brain or nervous system.
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My leukemia is Philadelphia chromosome positive.
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I am HIV-positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Relapse-free survival (RFS)
Secondary study objectives
Incidence of adverse events
Minimal residual disease negativity rate
Overall response rate
+1 more

Awards & Highlights

Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (blinatumomab, inotuzumab, combination chemotherapy)Experimental Treatment13 Interventions
See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
FDA approved
Cyclophosphamide
FDA approved
Cytarabine
FDA approved
Dexamethasone
FDA approved
Doxorubicin
FDA approved
Inotuzumab ozogamicin
FDA approved
Mercaptopurine
FDA approved
Methopterin
Not yet FDA approved
Ofatumumab
FDA approved
Prednisone
FDA approved
Rituximab
FDA approved
Sulfate ion
Not yet FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,168 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,385 Total Patients Enrolled
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
888 Total Patients Enrolled

Media Library

Blinatumomab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02877303 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Treatment (blinatumomab, inotuzumab, combination chemotherapy)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT02877303 — Phase 2
Blinatumomab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02877303 — Phase 2
~15 spots leftby Nov 2026
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