Tocilizumab for Graft-versus-Host Disease Prevention

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Checkpoint inhibitors

Disqualifiers: Myelofibrosis, HIV, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

46 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of the research in this study is to make participants' transplant safer by reducing the risk of developing GVHD and GVHD-related complications by giving participants a dose of the drug tocilizumab in addition to the standard approach for GVHD prevention. Tocilizumab reduces the risk of inflammation by blocking the effect of Interleukin-6, a protein that exists in high levels in the blood when there is inflammation. Participants who receive stem cell transplants have high levels of this protein in their blood early after transplant. Therefore, the goal of this study is to reduce the risk of inflammation after transplant with the addition of Tocilizumab. This could decrease the risk of developing GVHD and GVHD-associated complications.

Research Team

Ioannis Politikos, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I have acute myelogenous leukemia.

My condition is MDS/MPD, but not myelofibrosis.

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

Exclusion Criteria

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

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation and Treatment

Participants receive a double unit cord blood transplantation and a dose of tocilizumab to prevent GVHD

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after transplantation and treatment

12 weeks

Treatment Details

Interventions

• Tocilizumab

Trial Overview 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.

Participant Groups

Group I: Adult Participants With High Risk Hematologic Malignancies Experimental Treatment 5 Interventions

Tocilizumab is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Actemra for:

• Rheumatoid Arthritis
• Systemic Juvenile Idiopathic Arthritis
• Polyarticular Juvenile Idiopathic Arthritis
• Giant Cell Arteritis
• Cytokine Release Syndrome
• COVID-19

Approved in United States as Actemra for:

• Rheumatoid Arthritis
• Systemic Juvenile Idiopathic Arthritis
• Polyarticular Juvenile Idiopathic Arthritis
• Giant Cell Arteritis
• Cytokine Release Syndrome
• COVID-19

Approved in Canada as Actemra for:

• Rheumatoid Arthritis
• Systemic Juvenile Idiopathic Arthritis
• Polyarticular Juvenile Idiopathic Arthritis
• Giant Cell Arteritis
• Cytokine Release Syndrome
• COVID-19

Approved in Japan as Actemra for:

• Rheumatoid Arthritis
• Systemic Juvenile Idiopathic Arthritis
• Polyarticular Juvenile Idiopathic Arthritis
• Giant Cell Arteritis
• Cytokine Release Syndrome
• COVID-19

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+