Anemia Clinical Trial
Official title:
Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)
Verified date | October 2019 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | April 30, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 treatment |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 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. | Enrollment up to day 100 post T cell infusion for each arm. | |
Secondary | Immune Reconstitution | To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia | Up to 1 year | |
Secondary | Overall Response Rates | The overall response rates between the lenalidomide and non-lenalidomide arms. For response to treatment, it was measured by International Workshop on CLL (iwCLL), criteria 2008 guidelines. | Up to 1 year | |
Secondary | Incidence of Infections | To study the incidence of infections for up to 1 year following activated T cell infusion | Up to 1 year |
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