ClinicalTrials.gg
CompletedNCT03434730Updated May 26, 2026Results posted

Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation

A Phase 2 interventional study of Total Body Irradiation and Cyclosporine in Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Acute Leukemia, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 49 studies in Leukemia, Myeloid, Acute by Memorial Sloan Kettering Cancer Center — 9 open to participants now, 12 under way, none of them phase 3. Leukemia, Myeloid, Acute · Memorial Sloan Kettering Cancer Center.

Enrollment
9th of 32
46 · median 31
Started
2018
with 3 others
Phase 2
24 of 49
4 open now
Registered
32nd of 49
by date

Among the 49 studies in Leukemia, Myeloid, Acute by Memorial Sloan Kettering Cancer Center, this one is the 9th largest by enrollment of the 32 interventional ones that give a count, is one of 4 that started in 2018, is one of 24 in phase 2, and was the 32nd registered.

Leukemia, Myeloid, Acute

3,668 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.

Browse Leukemia, Myeloid, Acute studies →

Open to participants now

9 of the 49 studies in Leukemia, Myeloid, Acute by Memorial Sloan Kettering Cancer Center are open now, in 1 country. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 9 open studies →

Where they have run

Who these studies take

Of the 625 Leukemia, Myeloid, Acute studies recruiting now, 363 (58%) set no upper age limit and 222 (36%) stop at 75 or younger; 145 take children under 18; 29 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 49 studies in Leukemia, Myeloid, Acute by Memorial Sloan Kettering Cancer Center, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic-Myeloproliferative Diseases
  • Myeloproliferative Disorder
  • Non Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Leukemia

Keywords

  • tocilizumab
  • 17-616
  • Memorial Sloan Kettering Cancer Center
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

I. Acute myelogenous leukemia (AML)

  • Complete first remission (CR1) at high risk for relapse such as any of the following:
  • Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder
  • Therapy-related AML
  • White cell count at presentation > 100,000
  • Presence of extramedullary leukemia at diagnosis
  • Any unfavorable subtype by FAB or WHO classification
  • High-risk cytogenetics (e.g. those associated with MDS, abnormalities of 5, 7, 8, complex karyotype) or high risk molecular abnormalities
  • Requirement for 2 or more induction to achieve CR1
  • Any patient with newly diagnosed AML with intermediate risk cytogenetics who elects allograft with curative intent over consolidation chemotherapy
  • Any patient unable to tolerate consolidation chemotherapy as would have been deemed appropriate by the treating physician
  • Other high risk features not defined above
  • Complete second remission (CR2)
  • Primary or relapsed AML with less than 10% blasts before transplant. Persistent/relapsed AML with cytogenetic, flow cytometric, or molecular aberrations in >/= 10% of cells are eligible

II. Acute lymphoblastic leukemia (ALL)

  • Complete first remission (CR1) at high risk for relapse such as any of the following:
  • White cell count at presentation > 30,000 for B-cell lineage and > 100,00 for T-cell lineage
  • Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality
  • Failure to achieve complete remission after four weeks of induction therapy
  • Persistence or recurrence of minimal residual disease on therapy
  • Any patient with newly diagnosed ALL >/= 50 years-old
  • Any patient unable to tolerate consolidation and/or maintenance chemotherapy as would have been deemed appropriate by the treating physician
  • Other high risk features not defined above
  • Complete second remission (CR2)
  • Primary refractory or relapsed ALL with less than 5% blasts before transplant. Persistent/relapsed ALL with cytogenetic, flow cytometric or molecular aberrations in >/=5% of cells are eligible.

III. Other acute leukemias: leukemias of ambiguous lineage or of other types e.g. blastic plasmacytoid dendritic cell neoplasm with less than 5% blasts. Persistent/relapsed disease with cytogenetic, flow cytometric or molecular aberrations in >/=5% of cells are eligible

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

  • International prognostic scoring system (IPSS) risk score of INT-2 or high risk at the time of diagnosis
  • Any IPSS risk category if life-threatening cytopenia(s) exists
  • Any IPSS risk category with karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia
  • MDS/ myeloproliferative disorder overlap syndromes without myelofibrosis
  • MDS/ MPD patients must have less than 10% bone marrow myeloblasts and >/= 0.2 (growth factor supported if necessary) at transplant work-up

V. Non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) at high-risk of relapse or progression if not in remission:

  • Eligible patients with aggressive histologies (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histologies) in CR
  • Eligible patients with indolent B cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with stable disease/CR/PR with no single lesion equal to or more than 5 cm.
  • Eligible patients with HL will be without progression of disease (POD) after salvage chemotherapy with no single lesion equal to or more than 5cm.

Organ Function and Performance Status Criteria:

  • score >/= 70% (inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient)
  • Calculated >/= 60 ml/min
  • \< 1.5 mg/dL (unless benign congenital hyperbilirubinemia)
  • \</= 3 x
  • Pulmonary function (spirometry and corrected DLCO) >/= 50% predicted
  • greater than 50%
  • Albumin >/= 3.0
  • Age-adjusted Hematopoietic Cell Transplantation-Comorbidity Index (aaHCT-CI) less than or equal to 7

Graft Criteria:

2 CB units will be selected according to current MSKCC unit selection algorithm. High resolution 8 allele HLA typing and recipient HLA antibody profile will be performed. Unit selection will occur based on HLA-match, total nucleated cell (TNC) and CD34+ cell dose adjusted per patient body weight. The bank of origin will also be taken into account. Donor specific HLA antibodies, if present, will also be taken into consideration and may influence the selection of the graft.

  • Each CB unit must be at least 3/8 HLA-matched to the patient considering high resolution 8-allele HLA typing
  • Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 10\^7 TNC/ recipient body weight (TNC/ kg)
  • Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.0 x 10\^5 CD34+ cells/ recipient body weight (CD34+/kg).
  • A minimum of one domestic will be reserved as a backup unit.

Exclusion criteria

Exclusion Criteria:

  • Indolent NHL or Hodgkin lymphoma with POD after most recent salvage chemotherapy
  • Diagnosis of myelofibrosis or other with moderate-severe bone marrow fibrosis
  • Any diagnosis without prior chemotherapy within 3 months of intended admission for transplant
  • Prior / blockade in the last 12 months
  • Two prior stem cell transplants of any kind
  • One prior stem cell transplant within the preceding 12 months
  • One prior allogeneic stem cell transplant within the preceding 24 months
  • Prior radiation therapy with 400cGy or more of TBI
  • Active and uncontrolled infection at time of transplantation
  • infection
  • Seropositivity for HTLV-1.
  • Inadequate performance status/ organ function.
  • Pregnancy or breast feeding
  • Patient or guardian unable to give or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Adult Participants With High Risk Hematologic Malignancies

    Radiation: Total Body Irradiation · Drug: Cyclosporine · Drug: Mycophenolate Mofetil · Drug: Tocilizumab · Drug: Filgrastim

Interventions

  • RadiationTotal Body Irradiation

    Participants will receive a total dose of 400 cGy on day -2 and day -1 as 2 fractions (200 cGy x 2). Participants receiving total body irradiation (TBI) are treated in a standing position, and the treatment takes about 20 to 30 minutes.

    Also known as: TBI

  • Dilute in D5W or NS to make a 2.5 mg/ ml solution. Infuse slowly over approximately 1-4 hours (intermittent infusion) or 24 hours for continuous infusion.

    Also known as: Sandimmune

  • A 1000 mg dose should be placed in 140 ml of D5W. Administer only with D5W, over at least 2 hours.

    Also known as: CellCept

  • For participants \< 30kg, dilute with 50mL 0.9% sodium chloride. For participants ≥ 30kg, dilute to 100ml with 0.9% sodium chloride. Administer infusion over 60 minutes with infusion set.

    Also known as: Acemtra

  • The single use prefilled syringes contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively. For the prevention/treatment of chemotherapy induced neutropenia, the dose of filgrastim is standardized per body weight: ≤ 60 kg = 300 mcg daily subcutaneously; \> 60 kg = 480 mcg subcutaneously daily.

    Also known as: Granulocyte-Colony Stimulating Factor, Neupogen

06

What researchers measure

Primary outcomes

  1. Median Time in Days to Onset of Grade II-IV aGVHD by Day 100 After Study Treatment

    Median Time in Days to Onset of Grade II-IV aGVHD by Day 100 After Study Treatment

    Time frame: 100 days post treatment

07

Results

Posted May 26, 2026

Participant flow

Participant flow — Overall Study
MilestoneAdult Participants With High Risk Hematologic Malignancies
Started46
Completed30
Not completed16
Withdrew: Death9
Withdrew: Lost to follow-up2
Withdrew: Relapsed disease5

Outcome measures

PrimaryMedian Time in Days to Onset of Grade II-IV aGVHD by Day 100 After Study Treatment

Median Time in Days to Onset of Grade II-IV aGVHD by Day 100 After Study Treatment

Time frame:
100 days post treatment
Reported as:
Median · days
Median Time in Days to Onset of Grade II-IV aGVHD by Day 100 After Study Treatment
daysAdult Participants With High Risk Hematologic Malignancies
Median Time in Days to Onset of Grade II-IV aGVHD by Day 100 After Study Treatment34 (14 to 90)

Adverse events

Collected over through 100 days post treatment, up to 160 days total. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Adult Participants With High Risk Hematologic Malignancies16/45 (35.6%)5/45 (11.1%)26/45 (57.8%)
Most frequent serious events
Most frequent serious events
EventAdult Participants With High Risk Hematologic Malignancies
PneumonitisRespiratory, thoracic and mediastinal disorders1/45
Death, NOSGeneral disorders1/45
Infections and infestations - Other, specifyInfections and infestations1/45
SepsisInfections and infestations1/45
Infusion related reactionInjury, poisoning and procedural complications1/45
Most frequent other events
Showing 10 of 15
Most frequent other events
EventAdult Participants With High Risk Hematologic Malignancies
PainGeneral disorders15/45
AnorexiaMetabolism and nutrition disorders6/45
BacteremiaInfections and infestations6/45
Infusion Related ReactionInjury, poisoning and procedural complications4/45
HypoxiaRespiratory, thoracic and mediastinal disorders3/45
Rash-MaculopapularSkin and subcutaneous tissue disorders3/45
SepsisInfections and infestations2/45
Acute Renal FailureRenal and urinary disorders1/45
Bronchopulmonary hemorrhageRespiratory, thoracic and mediastinal disorders1/45
Cardiac ArrestCardiac disorders1/45

Baseline characteristics

Age, Continuous
Age, Continuous(years)Adult Participants With High Risk Hematologic Malignancies
Median45 (24 to 60)
Sex: Female, Male
Sex: Female, Male(Participants)Adult Participants With High Risk Hematologic Malignancies
Female24
Male22
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Adult Participants With High Risk Hematologic Malignancies
Hispanic or Latino9
Not Hispanic or Latino36
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Adult Participants With High Risk Hematologic Malignancies
American Indian or Alaska Native0
Asian8
Native Hawaiian or Other Pacific Islander0
Black or African American5
White29
More than one race0
Unknown or Not Reported4
Region of Enrollment
Region of Enrollment(Participants)Adult Participants With High Risk Hematologic Malignancies
United States46
08

Study locations

1 site
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
09

References and documents

Publications

  • Politikos I, Brown S, Fein JA, Eng S, Casem K, Chinapen S, Quach S, Scaradavou A, Cho C, Dahi P, Giralt SA, Gyurkocza B, Hanash AM, Jakubowski AA, Papadopoulos EB, Perales MA, Ponce DM, Shaffer BC, Tamari R, Young JW, Devlin S, Peled JU, Barker JN. Phase 2 trial of cyclosporine-A, mycophenolate mofetil, and tocilizumab GVHD prophylaxis in cord blood transplantation. Blood Adv. 2025 May 27;9(10):2570-2584. doi: 10.1182/bloodadvances.2024014177. PubMed 40423982 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Apr 2025, 86 months.

Results were first posted in May 2026, 1 year 1 month after primary completion.

Of 386 non-industry phase 2 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 108. This study's 86 months is above that.

Counting every sponsor, half of 443 studies reached it within 60 months; a quarter within 38 and three quarters within 104.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2018
First posted
Feb 15, 2018
StartActual
Feb 7, 2018
Primary completionActual
Apr 18, 2025
CompletionActual
Apr 18, 2025
Results first posted
May 26, 2026
Last update
May 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03434730
Responsible party
Sponsor
First posted
Feb 15, 2018
Start date
Feb 7, 2018
Primary completion
Apr 18, 2025
Completion
Apr 18, 2025
Results posted
May 26, 2026
Last update
May 26, 2026

Study contacts

Ioannis Politikos, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Tocilizumab

Start the discussion