NCT03434730

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

A Phase II Study of IL-6 Receptor Blockade to Ameliorate Acute Graft Versus Host Disease and Early Toxicity After Double Unit Cord Blood Transplantation in Adults With Hematologic Malignancies.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
RADIATION	Total 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.
DRUG	Cyclosporine	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.
DRUG	Mycophenolate Mofetil	A 1000 mg dose should be placed in 140 ml of D5W. Administer only with D5W, over at least 2 hours.
DRUG	Tocilizumab	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.
DRUG	Filgrastim	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.

Timeline

• Start date: 2018-02-07
• Primary completion: 2025-04-18
• Completion: 2025-04-18
• First posted: 2018-02-15
• Last updated: 2025-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study