Trials / Completed
CompletedNCT02530515
Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia
Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies the side effects of ex vivo-activated autologous lymph node lymphocytes infusion and to see how well they work in treating patients with chronic lymphocytic leukemia. Biological therapies, such as ex vivo-activated autologous lymph node lymphocytes, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.
Detailed description
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ex Vivo-activated Autologous Lymph Node Lymphocytes | Given IV |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2015-12-18
- Primary completion
- 2018-04-30
- Completion
- 2018-04-30
- First posted
- 2015-08-21
- Last updated
- 2019-10-29
- Results posted
- 2019-10-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02530515. Inclusion in this directory is not an endorsement.