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Treatment of B-CLL With Autologous IL2 and CD40 Ligand-Expressing Tumor Cells + Lenalidomide

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
B-cell Chronic Lymphocytic Leukemia

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Trial Information

Treatment of B-CLL With Autologous IL2 and CD40 Ligand-Expressing Tumor Cells + Lenalidomide

Previously, some of the cancer cells were taken from the subject's body and separated in the
laboratory and a specially produced human virus (adenovirus) that carries the IL-2 gene was
put into the cells. Adenovirus is a common virus found in human respiratory systems. In its
normal state, it can reproduce and cause a respiratory infection. Respiratory illnesses
caused by adenovirus infections range from the common cold to pneumonia, croup and
bronchitis. This adenovirus has been changed in the laboratory so that it is not likely to
reproduce or cause an infection once it is in the body. The gene transfer method used in
this study tries to add copies of the IL2 gene that increases the immune response against a

The rest of the cancer cells have been stimulated to express on their surface a substance
called the human CD40L. These substances (IL-2 and CD40L), already naturally present in the
body, are meant to help the immune system fight the cancer.

At the point that the doctor feels the subject should begin treatment on this protocol, the
treatment will be as follows:

The subject will begin taking Allopurinol by mouth at 300 mg and will continue taking
Allopurinol daily for 14 days. Allopurinol is also called Zyloprim and it will be taken to
prevent tumor lysis syndrome. Tumor lysis syndrome can be a serious condition that occurs
sometimes when cancer treatment is started. Tumor lysis syndrome can cause other medical

Two days after Allopurinol was started, the subject will begin taking Lenalidomide. The
Lenalidomide dose will be 5 mg taken by mouth daily. The subject should swallow the capsules
whole with water at the same time each day and should not break, chew or open the capsules.
Females of childbearing potential who are caring for the subject should not touch the
lenalidomide capsules or bottles without gloves. If a dose of lenalidomide is missed, it
should be taken as soon as possible on the same day. If it is missed for the entire day, it
should not be made up. If more than the prescribed dose is taken of lenalidomide and the
subject feels poorly, s/he should seek emergency medical care and tell the study staff right
away. The subject will get 1 cycle of drug per month. A max of a 28-day supply of the drug
will be provided at one time. If the subject has bad side effects the doctor may tell
him/her not to take the lenalidomide for a short time period or may be removed from the
study. Otherwise, the subject will continue daily dosing with Lenalidomide for approximately
1 year, until four weeks after the final vaccine.

Four weeks after the subject starts the Lenalidomide s/he will start to receive his/her
vaccines. The vaccine will be injected under the skin (also called subcutaneously). Normally
the subject will have the shots as an outpatient (no overnight stay in the hospital will be
required). S/he will receive the first five (5) shots at 2 week intervals. S/he will then
receive eleven (11) shots at 4 weekly intervals. In total, the subject may receive up to
sixteen (16) shots over a period of one year. As with the Lenalidomide if the subject has
bad side effects s/he may not receive his/her vaccines for a short period of time or may be
removed from the study. Otherwise, the subject will receive the vaccines on the schedule as
specified earlier in this paragraph. These shots must be given at the Methodist Hospital.

Following these injections, the doctor will follow the subject for 1 year after the last
shot to see how the subject is doing.


A complete history and physical examination is necessary before the subject can be enrolled
in the study. A physical examination will also be performed each time s/he receives a shot
of the modified cells. The place on the subject's body where s/he had received the shots
will be examined during the physical exam.

Research Blood Samples:

Blood will be taken from a tube placed into the vein (IV). We will take blood samples at the
following time points: at study entry, week 0 when the subject starts Lenalidomide, weeks 2,
4, 6, 8, 10 and 16 and then every 4 weeks until week 60. The last blood sample will be at
one year after the last shot. We will do this to make sure that the Lenalidomide is working
correctly and to study how the modified cells are working in the body.

The amount of blood that will be obtained each time is approximately 2-3 tablespoonfuls,
which is considered to be a safe amount. If the subject has a central line (an IV line that
has been placed in a large blood vessel that is meant to be used for long periods of time),
the blood will be taken from it, so that extra "sticks" should not be needed. Additional
office visits may be necessary to obtain this blood. The maximum total amount of blood to be
collected from the subject is 40-60 tablespoons.

Other tests: If the subject is a woman who can get pregnant, she will have pregnancy
counseling and urine tests as long as she is taking lenalidomide. The test will be done at
the following times: 10-14 days before she starts lenalidomide; within 24 hours of starting
lenalidomide; weekly for the first 4 weeks of taking lenalidomide; and then every 4 weeks
for the remainder of the study. If her periods are irregular, she will have another
pregnancy test done at 2 weeks. The last test will be 28 days after she stops lenalidomide.

A bone marrow sample will be taken from the subject before and at the end of the vaccination
period to assess the response to the treatment.

In order to participate in this study, the subject must register into and follow the
requirements of the RevAssist ® program of Celgene Corporation (the company that supplies
Lenalidomide). This program provides education and counseling on the risks of fetal
exposure, blood clots and reduced blood counts that can occur when taking Lenalidomide. The
subject will be required to receive counseling every 28 days during treatment with
lenalidomide, follow the pregnancy testing and birth control requirements of the program
that are appropriate for him/her and take telephone surveys regarding your compliance with
the program. Participating in the RevAssist program is a study requirement.

Inclusion Criteria:


- Patients with B-CLL (not in Richter's transformation) with measurable disease.

- Procurement consent signed and faxed to Research Coordinator

- HIV negative (can be pending at this time)


- Manipulated B-CLL cells available (at least 6 injections)

- Patients with B-CLL (not in Richter's transformation) with measurable disease

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

- Patients must be less than 75 years old

- Patients must have ECOG performance status of 0-2.

- Patients must have recovered from the toxic effects of all prior chemotherapy before
entering this study:

- Absolute neutrophil count (ANC) of greater than or equal to 500/microL

- Absolute lymphocyte count (ALC) greater than or equal 200/microL,

- Hemoglobin greater than or equal 8 g/dL

- Platelet count greater than or equal 50,000/microL.

- Patients must be willing to practice appropriate birth control methods during the
study and for 28 days after their participation in the treatment portion of the study
is concluded. Females of childbearing potential (FCBP) (see Note below) must have a
negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL
within 10 - 14 days and again within 24 hours prior to starting Cycle 1 of
lenalidomide and must either commit to continued abstinence from heterosexual
intercourse or begin TWO acceptable methods of birth control, one highly effective
method and one additional effective method AT THE SAME TIME, at least 28 days before
she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
Men must agree to use a latex condom during sexual contact with a FCBP even if they
have had a successful vasectomy. All patients must be counseled at a minimum of every
28 days about pregnancy precautions and risks of fetal exposure. In the full protocol
see Appendix G: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable
Birth Control Methods, AND also Appendix: Education and Counseling Guidance Document.

- Patients must have adequate liver function:

- Total bilirubin less than or equal to 1.5 mg/dl, SGOT less than or equal to 3 times

- Normal prothrombin time

- Patients must have adequate renal function (creatinine clearance greater than 50

- Patients provide informed consent.

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

- All study participants (treatment) must be registered in the RevAssist Program and be
willing to comply with the requirements of RevAssist.

Note: A female of childbearing potential is a sexually mature female who: 1) has not
undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
postmenopausal (amenorrhea following cancer therapy does not rule out childbearing
potential) for at least 24 consecutive months (i.e., has had menses at any time in the
preceding 24 consecutive months).

Exclusion Criteria:


- Infected at time of protocol entry, or receiving antibiotics (other than prophylactic
trimethoprim sulfamethoxazole).

- Pregnant or lactating

- Suffering from an autoimmune disease (including refractory immune
thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA)

- Receiving immunosuppressive drugs.

- Received systemic steroids within 30 days of study enrollment

- Autologous hematopoietic stem cell transplant or fludarabine chemotherapy within 6
months of study enrollment

- History of allogeneic stem cell transplant

- Patients with congestive heart failure or significant arrhythmia

- Known hypersensitivity to thalidomide or lenalidomide.

Type of Study:


Study Design:

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

Outcome Measure:

Adverse Events after Lenalidomide with B-CLL cell vaccine

Outcome Description:

To assess the safety of administration of lenalidomide combined with prolonged administration of CD40L expressing and IL-2 secreting B-CLL cells (B-CLL vaccine).

Outcome Time Frame:

week 60

Safety Issue:


Principal Investigator

Martha Mims, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine


United States: Food and Drug Administration

Study ID:

H-30087 TAIL



Start Date:

February 2013

Completion Date:

June 2019

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • B-CLL
  • vaccine
  • Lenalidomide
  • CTL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



The Methodist Hospital Houston, Texas  77030