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

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ClinicalTrials.gov Identifier: NCT02530515
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
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 Biological: Ex Vivo-activated Autologous Lymph Node Lymphocytes Other: Laboratory Biomarker Analysis Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)
Actual Study Start Date : December 18, 2015
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018


Arm Intervention/treatment
Experimental: Treatment (ex vivo autologous lymph node lymphocytes)
Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0.
Biological: Ex Vivo-activated Autologous Lymph Node Lymphocytes
Given IV
Other Names:
  • X-ACT
  • X-ACT Autologous Lymph Node Lymphocytes

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. Overall success rate, defined as achievement of a target activated T-cell dose of 1 x 10^8 +/- 20% and the lack of dose-limiting toxicity [ Time Frame: Up to 90 days ]
    A bayesian sequential monitoring rule will be employed to monitor the overall success rate.

  2. Efficacy, defined as achievement of the target T cell dose (1 x 10^8 +/- 20%) in > 50% of patients enrolled [ Time Frame: Up to 90 days ]
  3. Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 [ Time Frame: Up to 90 days ]

Secondary Outcome Measures :
  1. Immune reconstitution [ Time Frame: Up to 1 year ]
    The percentages and absolute values of cluster of differentiation ratio will be assessed and reported at each time point along with 95% confidence intervals.

  2. Overall response (complete response + partial response) [ Time Frame: Up to 1 year ]
    The response rate will be assessed separately by arm. The response rates will also be compared between the two arms by using Fisher's exact test.

  3. Rate of infections [ Time Frame: Up to 1 year ]
    The rate of infections will be assessed separately by arm and compared between the two arms by using Fisher's exact test.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530515


Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Chitra Hosing M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02530515     History of Changes
Other Study ID Numbers: 2014-0830
NCI-2015-01546 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0830 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Weight Loss
Fatigue
Thrombocytopenia
Neoplasms
Leukemia, Prolymphocytic
Lymphadenopathy
Communicable Diseases
Infection
Lymphocytosis
Neoplasms, Second Primary
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Body Weight Changes
Body Weight
Signs and Symptoms
Blood Platelet Disorders
Hematologic Diseases
Leukocytosis
Leukocyte Disorders