Primary Transplant Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT01646645|
Recruitment Status : Recruiting
First Posted : July 20, 2012
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cytomegalovirus||Biological: CMV-pp65 CTLs||Phase 2|
Expanded Access : An investigational treatment associated with this study is temporarily not available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Primary Transplant 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 :||July 2012|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Group I
This is a single-arm non-randomized single institution phase 2 trial, designed to evaluate the therapeutic activity of CMVpp65-CTLs generated from seropositive HSCT donors when adoptively transferred into transplant recipients with persistent CMV infection or viremia. Patients eligible for this trial will be consenting recipients of related or unrelated HSCT who have an active CMV infection or persistent CMV viremia for ≥ 2 weeks despite treatment with anti-viral agents or who cannot be maintained on anti-viral therapy due to treatment related toxicity.
Biological: CMV-pp65 CTLs
Patients will be treated with CMVpp65-CTLs derived from their transplant donor. These will be patients with CMV seropositive transplant donors who have previously provided leukocytes for generation of CMVpp65-CTL and for whom such CMVpp65-CTL are available. The T-cells to be infused will be selected based on criteria mentioned in section 4.0 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 106 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.
- efficacy CMV specific T cells [ Time Frame: 3 years ]The endpoint of this study is complete response, defined as the clearance of the CMV infection 3-7 weeks following completion of the last cycle of CMV CTLs. The evaluation of treatment efficacy will be assessed separately for patients receiving CMV specific T cells from their transplant donor.
- safety of CMV specific T cells [ Time Frame: 3 years ]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): NCT01646645
|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, 10065-0009|
|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|