Phase 2
Completed N=8
Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov NCT02530515 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT. — 7; 7 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT. |
7; 7 | — |
| SECONDARY Immune Reconstitution |
— | — |
| SECONDARY Overall Response Rates |
— | — |
| SECONDARY Incidence of Infections |
— | — |
Eligibility Criteria
Inclusion Criteria
- All patients must have a diagnosis of chronic lymphocytic leukemia (CLL) by immunophenotyping and flow cytometry analysis of blood or bone marrow
- Patients must meet criteria for treatment based on the criteria proposed by National Cancer Institute (NCI)-sponsored CLL Working Group to include at least one of the following:
- Weight loss of more than 10% over the preceding 6 months; or
- Extreme fatigue attributable to progressive disease; or
- Fever or night sweats without evidence of infection; or
- Worsening anemia (Rai stage Ill) or thrombocytopenia (Rai stage IV); or
- Massive lymphadenopathy (> 10 cm) or rapidly progressive lymphocytosis (lymphocyte doubling time 60%
- Calculated creatinine clearance (by Cockcroft-Gault) of > 50 ml/min
- Patients must not have untreated or uncontrolled life-threatening infection
- Patients must sign informed consent
Exclusion Criteria
- Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 weeks of registration
- Autoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment
Data sourced from ClinicalTrials.gov (NCT02530515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.