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Treatment of Chronic Lymphocytic B-Leukemia (B-CLL) With Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells (CLIPA)

Phase 1
18 Years
Not Enrolling
Leukemia, Leukemia, B-Cell, Chronic

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Trial Information

Treatment of Chronic Lymphocytic B-Leukemia (B-CLL) With Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells (CLIPA)

This is a phase I trial to assess the safety of a dose escalation of hCD40L-expressing
autologous tumor cells with a fixed dose of recombinant hIL-2 gene transduced autologous
leukemic blasts. All eligible patients will be treated with a minimum of three and up to six
injections. There will be no use of placebo or control subjects.

Inclusion Criteria:

- Patients are eligible for administration of their vaccine if they present with B-CLL
(not in Richters transformation) with (group A) or without (group B) (Inclusion of
B-CLL) measurable disease. Untreated or complete remission patients will be enrolled
for vaccine administration in a therapeutic (i.e., no chemotherapy) window of three
months. If during these three months (necessary to complete the vaccine study), the
patient presents with rapid clinical progression, he or she will be excluded from our
current study and will receive treatment according to the standard institutional
guidelines. IMPORTANT NOTE: vaccine production for complete remission patients can
only be achieved if tumor cells have been collected BEFORE entering complete

- Patients must have a life expectancy of at least 10 weeks.

- Patients must have ECOG performance status of 0-2 as below: 0 = up and about, no
restriction, 1 = Ambulatory, no strenuous activity, 2 = Ambulatory, capable of
self-care appropriate for age. Up and about > 50% of time, but unable to carry out
any physical activities or attend school, 3 = Limited self-care only. Up and about <
50% of time, 4 = Disabled, no self care. Bedridden or confined to chair.

- Patients must have recovered from the toxic effects of all prior chemotherapy before
entering this study, and must have an absolute neutrophil count (ANC) of > / =
500/mL, absolute lymphocyte count (ALC) > / = 200/mL, hemoglobin > / = 8g/dL, and
platelet count > / = 50,000/mL

- Patients must not be infected at time of protocol entry, and should not be receiving
antibiotics (other than prophylactic trimethoprim sulfamethoxazole).

- Patients must be HIV-negative.

- Patients must be willing to practice appropriate birth control methods during the
study and for 3 months after the study is concluded. This includes total abstinence,
oral contraceptives, an intrauterine device, contraceptive implants under the skin,
contraceptive injections (Depo-Provera). Contraceptive foam with a condom is allowed.
The male partner should use a condom.

- Patients must not be suffering from an autoimmune disease (including active
graft-versus-host disease-GvHD, refractory immune thrombocytopenia-ITP or refractory
autoimmune hemolytic anemia-AIHA) and should not be receiving immunosuppressive

- Patients must have adequate liver function (total bilirubin < / = 1.5mg/dl, SGOT < /
= 2 times normal, normal prothrombin time).

- Patients must have adequate renal function (creatinine less than 3 times normal for
age or creatinine clearance > 80mg/min/1.73m2).

- Patients must sign an informed consent indicating that they are aware this is a
research study and have been told of its possible benefits and toxic side-effects.
Patients will be given a copy of the consent form.

- Patient must not have received treatment with other investigational agents within the
last 4 weeks.

Exclusion Criteria:

- Richters transformation (aggressive non-Hodgkins lymphoma),

- active infection,

- significant autoimmune disease (including active GvHD, ITP and AIHA),

- requirement for immunosuppressive drugs,

- inadequate liver and/or renal function,

- pregnancy or lactation,

- refusal to practice birth control methods,

- seropositive for HIV,

- life expectancy less than 10 weeks

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety of injections of autologous malignant B cells from B-CLL patients, which have been modified to secrete hIL-2 and hCD40L.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator


Investigator Role:

Study Chair

Investigator Affiliation:

Baylor College of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

January 2003

Completion Date:

March 2010

Related Keywords:

  • Leukemia
  • Leukemia, B-Cell, Chronic
  • Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, B-Cell



The Methodist Hospital Houston, Texas  77030