Clinical trial · Interventional
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)
NCT02530515CI-TRIAL-00041343completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Cancer Fatigue | — | UNRESOLVED | — |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Fever | — | UNRESOLVED | — |
| Infectious Disorder | — | UNRESOLVED | — |
| Lymphadenopathy | — | UNRESOLVED | — |
| Lymphocytosis | — | UNRESOLVED | — |
| Night Sweats | — | UNRESOLVED | — |
| Prolymphocytic Leukemia | Prolymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Recurrent Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ex Vivo-activated Autologous Lymph Node Lymphocytes | Biological | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (ex vivo autologous lymph node lymphocytes)
- description
- Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0.
- interventionNames
- Biological: Ex Vivo-activated Autologous Lymph Node Lymphocytes
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.
- timeFrame
- Enrollment up to day 100 post T cell infusion for each arm.
- description
- Success will be defined as achievement of a target activated T-cell dose of 1x108 +/-20% without DLT and the lack of dose limiting toxicity (DLT). DLT for this trial is defined as any Grade 4 or higher non-hematologic toxicity or grade 3 or 4 allergy/immunology toxicity, allergic reaction or urticaria grade 3 or higher by +90 days after T cell infusion, Grade 2 or greater autoimmune phenomena, or Grade 4 or higher hematologic toxicity (with the exception of any preexisting AE due to prior treatment or due to disease) deemed related to T cells and occurring by day +90 after T cell infusion. Feasibility is defined as achievement of the target T-cell dose (1x108 +/-20% ) without DLT in \>50% of patients enrolled.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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 \< 6 months); or
* Prolymphocytic or Richter's transformation; or
* Patients with CLL who have received at least one prior line of therapy; or
* Patients with CLL who have frequent infections and/or recurrent secondary cancers
* No active central nervous system (CNS) disease
* All patients must have a Karnofsky performance score \> 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 treatmentReferences
Publications (0)
Data not yet available
No reference posted for this study.