Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT02530515|
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : December 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anemia Cancer Fatigue Chronic Lymphocytic Leukemia Fever Infectious Disorder Lymphadenopathy Lymphocytosis Night Sweats Prolymphocytic Leukemia Recurrent Chronic Lymphocytic Leukemia Richter Syndrome Secondary Malignant Neoplasm Thrombocytopenia Weight Loss||Biological: Ex Vivo-activated Autologous Lymph Node Lymphocytes Other: Laboratory Biomarker Analysis||Phase 2|
I. To assess the feasibility and safety of infusion of autologous activated T-cells (ex vivo-activated autologous lymph node lymphocytes) in patients with chronic lymphocytic leukemia.
I. To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia.
II. To study the incidence of infections for up to 1 year following activated T cell infusion.
III. To study the overall response rates.
Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes intravenously (IV) over 10-30 minutes on day 0.
Patients who have been previously treated on study, and subsequently need additional infusions, may be retreated with previously cryopreserved expanded cells at the same or lower dose level 6-12 months after the first infusion.
After completion of study treatment, patients are followed up at 1.5 years and then every 6 months for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)|
|Actual Study Start Date :||December 18, 2015|
|Actual Primary Completion Date :||April 30, 2018|
|Actual Study Completion Date :||April 30, 2018|
Experimental: Treatment (ex vivo autologous lymph node lymphocytes)
Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0.
Biological: Ex Vivo-activated Autologous Lymph Node Lymphocytes
Other: Laboratory Biomarker Analysis
- Overall success rate, defined as achievement of a target activated T-cell dose of 1 x 10^8 +/- 20% and the lack of dose-limiting toxicity [ Time Frame: Up to 90 days ]A bayesian sequential monitoring rule will be employed to monitor the overall success rate.
- Efficacy, defined as achievement of the target T cell dose (1 x 10^8 +/- 20%) in > 50% of patients enrolled [ Time Frame: Up to 90 days ]
- Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 [ Time Frame: Up to 90 days ]
- Immune reconstitution [ Time Frame: Up to 1 year ]The percentages and absolute values of cluster of differentiation ratio will be assessed and reported at each time point along with 95% confidence intervals.
- Overall response (complete response + partial response) [ Time Frame: Up to 1 year ]The response rate will be assessed separately by arm. The response rates will also be compared between the two arms by using Fisher's exact test.
- Rate of infections [ Time Frame: Up to 1 year ]The rate of infections will be assessed separately by arm and compared between the two arms by using Fisher's exact test.
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): NCT02530515
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Chitra Hosing||M.D. Anderson Cancer Center|