Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03434730|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Acute Leukemia Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorder Non Hodgkin Lymphoma Hodgkin Lymphoma Leukemia||Radiation: Total Body Irradiation Drug: Cyclosporine Drug: Mycophenolate Mofetil Drug: Tocilizumab Drug: Filgrastim||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||February 7, 2018|
|Estimated Primary Completion Date :||February 7, 2021|
|Estimated Study Completion Date :||February 7, 2021|
|Experimental: Adult Participants With High Risk Hematologic Malignancies||
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.
Other Name: 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.
Other Name: Sandimmune
Drug: Mycophenolate Mofetil
A 1000 mg dose should be placed in 140 ml of D5W. Administer only with D5W, over at least 2 hours.
Other Name: 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.
Other Name: 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.
- Incidence of grade II-IV aGVHD by day 100 after study treatment [ Time Frame: 100 days post treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434730
|Contact: Ioannis Politikos, MDfirstname.lastname@example.org|
|Contact: Juliet Barker, MBBSemail@example.com|
|United States, New York|
|Memorial Sloan - Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Ioannis Politikos, MD 212-639-2054|