AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Non Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT03434769|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : March 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin Lymphoma||Drug: Cyclophosphamide Drug: Fludarabine Biological: CAR-T Cells||Phase 1|
Primary Objective: To determine the safety of the treatment of relapsed or refractory B cell lymphomas with chimeric antigen receptor T cells targeting cluster of differentiation antigen 19 (CD19) and to find the recommended phase II dose for this cellular therapy
- To describe the safety profile of the infusion of CAR-T cells targeting CD19.
- To describe the toxicities related to infusion of CAR-T cells targeting CD19.
- To describe the overall response rate and complete response rate of relapsed B cell malignancies treated with CAR-T cells targeting CD19.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Trial of AntiCD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non Hodgkin Lymphoma|
|Actual Study Start Date :||May 2, 2018|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: Cyclophosphamide + Fludarabine + Infusion of CAR-T Cells
Lymphodepletive regimen, consisting of Cyclophosphamide 60mg/kg IV on day -6 and Fludarabine 25mg/m2 IV on days -5 to -3. Followed by infusion of Chimeric antigen receptor T-cells (CAR-T) on day 0
Cyclophosphamide 60mg/Kg on day -6
Fludarabine 25mg/m^2 IV on days -5 to -3
Other Name: Fludara
Biological: CAR-T Cells
Chimeric antigen receptor T cells to be implemented in a "3 + 3" design on day 0
Level -1 (1 x 105 cells/kg)
Level 1 [Starting dose] (5 x 105 cells/kg)
Level 2 (1 x 106 cells/kg)
Level 3 (2 x 106 cells/kg)
- Number of patients with Lymphoma response [ Time Frame: Up to 12 months after getting CAR-T infusion ]The 2014 Lugano Response for Malignant Lymphoma will be used the following categories of response: : Complete Response (CR), Partial Response (PR), Stable Disease (SD), Relapse and Progression (PD).
- Duration of response [ Time Frame: Up to 12 months after getting CAR-T infusion ]This is measured, only in responders, from the documented beginning of response (CR or PR) to the time of relapse.
- Disease-free survival [ Time Frame: Up to 12 months after getting CAR-T infusion ]Survival is defined as the date of study entry to the date of death. Disease-free survival is measured from the time of occurrence of disease-free state to disease recurrence or death from lymphoma or acute toxicity of treatment.
- Disease-specific survival [ Time Frame: Up to 12 months after getting CAR-T infusion ]To minimize the risk of bias, the event should be recorded as death from lymphoma, or from toxicity from the drug. Death from unknown causes should be attributed to the drug.
- Progression-free survival [ Time Frame: Up to 12 months after getting CAR-T infusion ]Progression-free Survival (PFS) is defined as the time from entry onto study until lymphoma progression or death from any cause.
- Time to progression [ Time Frame: Up to 12 months after getting CAR-T infusion ]Time to progression (TTP) is defined as the time from study entry until lymphoma progression or death due to lymphoma.
- Time to treatment failure [ Time Frame: Up to 12 months after getting CAR-T infusion ]Time to treatment failure (event-free survival) is measured from the time from study entry to any treatment failure including discontinuation of treatment for any reason
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): NCT03434769
|Contact: Paolo F Caimi, MDemail@example.com|
|United States, Missouri|
|Washington University School of Medicine||Not yet recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Armin Ghobadi, MD|
|Principal Investigator: Armin Ghobadi, MD|
|United States, Ohio|
|University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106-5065|
|Contact: Paolo F. Caimi, MD 800-241-6422 firstname.lastname@example.org|
|Principal Investigator: Paolo F. Caimi, MD|
|Principal Investigator:||Paolo F Caimi, MD||University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|