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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
No Placebo-Only Group
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 belowSelect...
I have acute myelogenous leukemia.
Select...
My condition is MDS/MPD, but not myelofibrosis.
Select...
My blood disorder has genetic markers indicating a high risk of turning into acute leukemia.
Select...
My cancer remains after treatment.
Select...
I have AML and chose a stem cell transplant over chemotherapy.
Select...
My cancer has high-risk genetic changes.
Select...
My aggressive cancer type is in complete remission.
Select...
My condition involves high-risk genetic changes.
Select...
My leukemia was found outside my bone marrow at diagnosis.
Select...
My lymphoma is at high risk of getting worse if not in remission.
Select...
I needed 2 or more treatments to first achieve complete remission.
Select...
My leukemia has returned or didn't respond to treatment, but less than 5% of my cells are abnormal before a transplant.
Select...
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?
Select...
I am 50 years or older with newly diagnosed acute lymphoblastic leukemia.
Select...
I have been diagnosed with MDS or a myeloproliferative disorder before.
Select...
My leukemia is caused by previous cancer treatments.
Select...
My cord blood unit matches at least half of my HLA markers.
Select...
My AML didn't respond well to initial treatment or has come back, but with less than 10% cancer cells before transplant.
Select...
I have life-threatening low blood cell counts.
Select...
I have an overlap syndrome of MDS/MPN without myelofibrosis.
Select...
My condition is acute lymphoblastic leukemia (ALL).
Select...
My cancer did not fully respond after 4 weeks of initial treatment.
Select...
My Hodgkin's lymphoma hasn't worsened after my last treatment, and I don't have any tumors larger than 5cm.
Select...
My leukemia is of a specific type or has relapsed with certain cell changes.
Select...
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.
Select...
I haven't had immunosuppressive chemotherapy in the last 3 months.
Select...
I have received radiation therapy with a dose of 400cGy or more.
Select...
I am HIV positive.
Select...
I have been diagnosed with myelofibrosis or another cancer that affects my bone marrow severely.
Select...
I have had two stem cell transplants.
Select...
I am able to give informed consent and follow the treatment and research requirements.
Select...
My health is too poor for this trial.
Select...
I haven't had checkpoint inhibitor therapy in the last year.
Select...
My slow-growing lymphoma or Hodgkin's has worsened after the latest treatment.
Select...
I had a stem cell transplant using my own cells within the last year.
Select...
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
Treatment Details
Side effects data
From 2017 Phase 4 trial • 59 Patients • NCT0203447411%
Low ANC
5%
nausea
5%
agranulocytosis
5%
Inpatient admission
5%
fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tocilizumab
Awards & Highlights
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: 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
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,366 Total Patients Enrolled
Ioannis Politikos, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
54 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I do not have an active, uncontrolled infection at the time of transplantation.My cancer remains after treatment.I have AML and chose a stem cell transplant over chemotherapy.You cannot handle the chemotherapy treatment that your doctor thinks is best for you.I cannot handle the standard follow-up chemotherapy.My cancer has high-risk genetic changes.I haven't had immunosuppressive chemotherapy in the last 3 months.I have received radiation therapy with a dose of 400cGy or more.I am HIV positive.My aggressive cancer type is in complete remission.I have been diagnosed with myelofibrosis or another cancer that affects my bone marrow severely.I had a stem cell transplant from a donor within the last 2 years.My B cell NHL has progressed for the 2nd time or more, but no tumor is larger than 5 cm.My cancer is in its second complete remission.My cancer is in early remission but at high risk of coming back.My condition was considered intermediate-2 or high risk when diagnosed.My donor and I will be matched using detailed genetic testing to ensure compatibility.My condition involves high-risk genetic changes.I have had two stem cell transplants.My cord blood unit has the required amount of CD34+ cells for my body weight.I am able to give informed consent and follow the treatment and research requirements.My leukemia was found outside my bone marrow at diagnosis.My lymphoma is at high risk of getting worse if not in remission.My health is too poor for this trial.My bone marrow has less than 10% myeloblasts and my ANC is at least 0.2.I am mostly independent and can care for myself.You are pregnant or breastfeeding.I needed 2 or more treatments to first achieve complete remission.My leukemia has returned or didn't respond to treatment, but less than 5% of my cells are abnormal before a transplant.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?I am 50 years or older with newly diagnosed acute lymphoblastic leukemia.I have been diagnosed with MDS or a myeloproliferative disorder before.My leukemia is caused by previous cancer treatments.My cord blood unit matches at least half of my HLA markers.My AML didn't respond well to initial treatment or has come back, but with less than 10% cancer cells before transplant.I have life-threatening low blood cell counts.My kidneys are functioning well.I have an overlap syndrome of MDS/MPN without myelofibrosis.My condition is acute lymphoblastic leukemia (ALL).There are other factors that put you at high risk, but they are not specifically listed here.My health score for a specific transplant is 7 or lower.My cord blood unit meets the minimum cell count requirement.My cancer did not fully respond after 4 weeks of initial treatment.I haven't had checkpoint inhibitor therapy in the last year.My Hodgkin's lymphoma hasn't worsened after my last treatment, and I don't have any tumors larger than 5cm.My leukemia is of a specific type or has relapsed with certain cell changes.My slow-growing lymphoma or Hodgkin's has worsened after the latest treatment.I had a stem cell transplant using my own cells within the last year.My heart pumps blood well.
Research Study Groups:
This trial has the following groups:- Group 1: Adult Participants With High Risk Hematologic Malignancies
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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