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Monoclonal Antibodies

Tocilizumab for Graft-versus-Host Disease Prevention

Phase 2

Waitlist Available

Led By Ioannis Politikos, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

I. Acute myelogenous leukemia (AML)

IV. Myelodysplastic Syndrome (MDS)/ Myeloproliferative Disorders (MPD) other than myelofibrosis:

Must not have

Active and uncontrolled infection at time of transplantation

Any diagnosis without prior immunosuppressive chemotherapy within 3 months of intended admission for transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing whether the addition of the drug tocilizumab to the standard approach for GVHD prevention can reduce the risk of developing GVHD and GVHD-related complications. Tocilizumab works by blocking the effect of Interleukin-6, a protein that is elevated in the blood during periods of inflammation. This could potentially decrease the risk of developing GVHD and GVHD-associated complications.

Who is the study for?

This trial is for people with certain blood cancers or disorders who haven't had recent immunosuppressive chemo, stem cell transplants within specific time frames, or high-dose radiation. They need to be in good health otherwise, not pregnant or breastfeeding, and able to follow the study plan.

What is being tested?

The trial tests if Tocilizumab can make cord blood transplants safer by lowering the risk of Graft Versus Host Disease (GVHD). It's given alongside standard GVHD prevention treatments like Mycophenolate Mofetil and Cyclosporine.

What are the potential side effects?

Tocilizumab might cause allergic reactions, liver issues, lowered immune response making infections more likely, and changes in blood test results. Other drugs used may also contribute to side effects such as kidney damage and mouth sores.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have acute myelogenous leukemia.

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My condition is MDS/MPD, but not myelofibrosis.

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My blood disorder has genetic markers indicating a high risk of turning into acute leukemia.

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My cancer remains after treatment.

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I have AML and chose a stem cell transplant over chemotherapy.

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My cancer has high-risk genetic changes.

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My aggressive cancer type is in complete remission.

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My condition involves high-risk genetic changes.

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My leukemia was found outside my bone marrow at diagnosis.

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My lymphoma is at high risk of getting worse if not in remission.

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I needed 2 or more treatments to first achieve complete remission.

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My leukemia has returned or didn't respond to treatment, but less than 5% of my cells are abnormal before a transplant.

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I'm sorry, I think you accidentally left out the criterion you wanted me to summarize. Could you please provide it so I can assist you better?

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I am 50 years or older with newly diagnosed acute lymphoblastic leukemia.

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I have been diagnosed with MDS or a myeloproliferative disorder before.

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My leukemia is caused by previous cancer treatments.

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My cord blood unit matches at least half of my HLA markers.

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My AML didn't respond well to initial treatment or has come back, but with less than 10% cancer cells before transplant.

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I have life-threatening low blood cell counts.

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I have an overlap syndrome of MDS/MPN without myelofibrosis.

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My condition is acute lymphoblastic leukemia (ALL).

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My cancer did not fully respond after 4 weeks of initial treatment.

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My Hodgkin's lymphoma hasn't worsened after my last treatment, and I don't have any tumors larger than 5cm.

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My leukemia is of a specific type or has relapsed with certain cell changes.

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My cancer is in its second complete remission.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have an active, uncontrolled infection at the time of transplantation.

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I haven't had immunosuppressive chemotherapy in the last 3 months.

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I have received radiation therapy with a dose of 400cGy or more.

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I am HIV positive.

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I have been diagnosed with myelofibrosis or another cancer that affects my bone marrow severely.

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I have had two stem cell transplants.

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I am able to give informed consent and follow the treatment and research requirements.

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My health is too poor for this trial.

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I haven't had checkpoint inhibitor therapy in the last year.

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My slow-growing lymphoma or Hodgkin's has worsened after the latest treatment.

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I had a stem cell transplant using my own cells within the last year.

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I had a stem cell transplant from a donor within the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474

11%

Low ANC

nausea

agranulocytosis

Inpatient admission

fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Tocilizumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adult Participants With High Risk Hematologic MalignanciesExperimental Treatment5 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

Total Body Irradiation

2006

Completed Phase 3

~820

Cyclosporine

1997

Completed Phase 3

~1820

Filgrastim

2000

Completed Phase 3

~3690

0 / 37Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,956 Previous Clinical Trials

595,510 Total Patients Enrolled

Ioannis Politikos, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

54 Total Patients Enrolled

Media Library

Tocilizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03434730 — Phase 2

Acute Leukemia Research Study Groups: Adult Participants With High Risk Hematologic Malignancies

Acute Leukemia Clinical Trial 2023: Tocilizumab Highlights & Side Effects. Trial Name: NCT03434730 — Phase 2

Tocilizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03434730 — Phase 2

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