Trial of Immune Reconstitution With Activated T-Cells Following Lymphodepleting Chemotherapy in Patients With Chronic Lymphocytic Leukemia (CLL)

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 40
• Participant gender: Both

Summary

Patient's immune systems are often damaged by chemotherapy or by CLL. Researchers want to learn if giving T-cells (immune cells) that have been expanded and specially processed in the laboratory (activated) will help CLL patients' immune systems recover after chemotherapy. This may help lower the chance of infections.

The goal of this clinical research study is to learn if an activated T-cell infusion, when given with or without lenalidomide, can help to restore patients' immune systems when given after chemotherapy (rituximab and fludarabine with cyclophosphamide or bendamustine). The safety of this treatment combination will also be studied.

Researchers also want to learn if the activated T-cells may also be able to kill cancer cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Bendamustine Hydrochloride; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Lenalidomide; Rituximab; Thalidomide; Vidarabine
• Last Updated: 2016-10-06

Criteria

Inclusion Criteria:

1. All patients must have a diagnosis of CLL by immunophenotyping and flow cytometry analysis of blood or bone marrow. 1) Patients must meet criteria for treatment based on the criteria proposed by NCI-sponsored CLL Working Group to include at least one of the following: a) weight loss of more than 10% over the preceding 6 months; or, b) extreme fatigue attributable to progressive disease; or, c) fever or night sweats without evidence of infection; or, d) worsening anemia (Rai stage Ill) or thrombocytopenia (Rai stage IV); or, e) massive lymphadenopathy (>10 cm) or rapidly progressive lymphocytosis (lymphocyte doubling time <6 months); or, f) prolymphocytic or Richter's transformation; or, 2) Patients with CLL who have received at least one prior line of therapy; or, 3) Patients with CLL who have frequent infections and/or recurrent secondary cancers.

2. No active CNS disease.

3. All patients must have a Karnofsky Performance Score > 60%.

4. Calculated creatinine clearance (by Cockcroft-Gault) of > 50 ml/min.

5. Patients must not have untreated or uncontrolled life-threatening infection.

6. Patients must sign informed consent.

7. Females of childbearing potential must have a negative serum pregnancy test with a minimum sensitivity of 50 mIU/mL and agree to use two medically accepted forms of contraception from the time of initial screening through completion of the study or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting lenalidomide; 2) throughout the entire duration of lenalidomide treatment; 3) during dose interruptions; and 4) for at least 28 days after lenalidomide discontinuation.

8. Females of reproductive potential who will receive lenalidomide must adhere to the scheduled pregnancy testing as required in the Revlimid REMS(TM) program.

9. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy.

10. All study participants who will receive lenalidomide must be registered into the mandatory Revlimid REMS(TM) program, and be willing and able to comply with the requirements of the REMS(TM) program.

11. Patients who meet eligibility for the protocol but are not candidates to receive further chemotherapy may be treated on Arm C.

12. Patients with 17p deletion can only be enrolled on Arm C. These patients will receive the expanded T cells without lymphodepleting chemotherapy.

Exclusion Criteria:

1. Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 weeks of registration.

2. Autoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment.