Trial of Third Party Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell 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: NCT02136797|
Recruitment Status : Recruiting
First Posted : May 13, 2014
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|CMV Infection Persistent CMV Viremia||Biological: CMVpp65 Specific T-cells||Phase 2|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Third Party Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation|
|Actual Study Start Date :||May 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: CMVpp65-CTL T-cells
The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement.
Biological: CMVpp65 Specific T-cells
- complete response [ Time Frame: 2 years ]defined as the clearance of the CMV infection 3-7 weeks following completion of the last cycle of CMV CTLs.
- safety [ Time Frame: 2 years ]Will be capturing and tracking Grade 3-5 toxicities which occur within 30 days following an infusion of CMVpp65-specific. For the evaluation of toxicities, the NCI Standard Toxicity Scale 4.0 will be employed.
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): NCT02136797
|Contact: Susan Prockop, MD||212-639-6715|
|Contact: Aisha Hasan, MD||212-639-3267|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Susan Prockop, MD 212-639-6715|
|Contact: Aisha Hasan, MD 212-639-3267|
|Principal Investigator: Susan Prockop, MD|
|Principal Investigator:||Susan Prockop, MD||Memorial Sloan Kettering Cancer Center|