Phase 2 N=8 Treatment

Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia

Anemia · Cancer Fatigue · Chronic Lymphocytic Leukemia · Fever · Infectious Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02530515 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: 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 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ex Vivo-activated Autologous Lymph Node Lymphocytes (Biological); Laboratory Biomarker Analysis (Other)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Apr 2018

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	—	—

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.

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

View full record on ClinicalTrials.gov →

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.