NCT03434730

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

Completed Phase 2 Last updated 22 April 2025

What this trial tests

Phase 2 trial testing Total Body Irradiation in Acute Myeloid Leukemia in 46 participants. Completed in 18 April 2025.

Timeline

7 February 2018

Primary endpoint
18 April 2025

18 April 2025

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	7 February 2018
Primary completion	18 April 2025
Estimated completion	18 April 2025
Sites	1 location across United States

Drugs / interventions tested

• Total Body Irradiation
• Cyclosporine (cyclosporine) — full drug profile →
• Mycophenolate Mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
• Tocilizumab (tocilizumab) — full drug profile →
• Filgrastim

Conditions studied

• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
• Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
• Acute Leukemia — all drugs for Acute Leukemia →
• Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

Adults 18 to 65, any sex, with Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Can we use interleukin-6 (IL-6) blockade for coronavirus disease 2019 (COVID-19)-induced cytokine release syndrome (CRS)?
   Liu B, Li M, Zhou Z, Guan X, et al · · 2020 · cited 507× · PMID 32291137 · DOI 10.1016/j.jaut.2020.102452
2. Current approaches to prevent and treat GVHD after allogeneic stem cell transplantation.
   Hamilton BK. · · 2018 · cited 52× · PMID 30504315 · DOI 10.1182/asheducation-2018.1.228
3. Robust CD4+ T-cell recovery in adults transplanted with cord blood and no antithymocyte globulin.
   Politikos I, Lavery JA, Hilden P, Cho C, et al · · 2020 · cited 39× · PMID 31935291 · DOI 10.1182/bloodadvances.2019000836
4. Insights into the role of the JAK/STAT signaling pathway in graft-<i>versus</i>-host disease.
   Abboud R, Choi J, Ruminski P, Schroeder MA, et al · · 2020 · cited 33× · PMID 32537114 · DOI 10.1177/2040620720914489
5. Targeting pivotal inflammatory pathways in COVID-19: A mechanistic review.
   Yarmohammadi A, Yarmohammadi M, Fakhri S, Khan H. · · 2021 · cited 27× · PMID 33038418 · DOI 10.1016/j.ejphar.2020.173620
6. Challenges and opportunities targeting mechanisms of epithelial injury and recovery in acute intestinal graft-versus-host disease.
   Jansen SA, Nieuwenhuis EES, Hanash AM, Lindemans CA. · · 2022 · cited 24× · PMID 35654837 · DOI 10.1038/s41385-022-00527-6
7. Extended-duration letermovir prophylaxis for cytomegalovirus infection after cord blood transplantation in adults.
   Politikos I, Lau C, Devlin SM, Quach S, et al · · 2022 · cited 22× · PMID 35802462 · DOI 10.1182/bloodadvances.2022008047
8. Inflammatory monocytes promote pre-engraftment syndrome and tocilizumab can therapeutically limit pathology in patients.
   Jin L, Sun Z, Liu H, Zhu X, et al · · 2021 · cited 20× · PMID 34230468 · DOI 10.1038/s41467-021-24412-1