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Lenalidomide in Combination With Rituximab as Treatment for Patients With Relapsed Chronic Lymphocytic Leukemia - RV-CLL-PI-0292


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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Trial Information

Lenalidomide in Combination With Rituximab as Treatment for Patients With Relapsed Chronic Lymphocytic Leukemia - RV-CLL-PI-0292


The Study Drugs:

Lenalidomide is designed to change the body's immune system and may also interfere with the
development of tiny blood vessels that help support tumor growth. Therefore, in theory, it
may decrease the growth of cancer cells.

Rituximab is designed to bind to a protein, called CD20, that is on the surface of the
leukemia cells, allowing the leukemia cells to be destroyed by the immune system.

Drug Administration:

If you are found to be eligible to take part in this study, you will receive rituximab
through a needle into your vein 1 time a week in Cycle 1. You will not receive rituximab
during Cycle 2, but you will continue to take lenalidomide.You will receive a dose of
rituximab by vein on Day 1 of Cycles 3-12. Your first dose of rituximab will be given over
6-8 hours. If the first dose is well tolerated, you may receive the next doses over 2-4
hours. If the doctor thinks it is needed, the next doses may given over a longer time.

On Day 9 of Cycle 1, you will begin taking lenalidomide by mouth once a day. You will then
take lenalidomide once a day, every day.

The dose and schedule of lenalidomide may change depending on the side effects you may
experience. You should swallow lenalidomide capsules whole with a glass (8 ounces) water at
the same time each day. Do not break, chew, or open the capsules. If you miss a dose of
lenalidomide, take it as soon as you remember on the same day. If you miss a dose, it should
NOT be made up on another day.

You need to tell the study staff before you start or stop taking any drug.

Each study cycle is 4 weeks.

Study Visits:

Once a week during the first 5 weeks, blood (about 1 tablespoon) will be drawn for routine
tests.

After the first 5 weeks, blood (about 1 tablespoon) will be drawn for routine tests every 2
weeks until the doctor thinks your dose of lenalidomide will not change. After this, blood
(about 1 tablespoon) will then be drawn every 4 weeks for routine tests.

At the end of Cycles 3, 6, and 12, you will have a bone marrow biopsy and aspirate to check
the status of the disease. Blood (about 1 tablespoon) will be drawn for routine blood tests.

If you stay on study past 12 cycles, once every 6 cycles (Cycles 18, 24, 30, and so on), you
will have a bone marrow biopsy and aspirate to check the status of the disease. Blood (about
1 tablespoon) will be drawn for routine blood tests.

Blood (about 1 tablespoon) will be drawn more often if the dose of lenalidomide needs to be
changed or if you experience intolerable side effects.

Pregnancy Testing:

Women who are able to become pregnant must have a negative urine or blood (less than 1
teaspoon) pregnancy test 10-14 days and 24 hours before the first dose of lenalidomide, even
if they have not had a menstrual period due to treatment of the disease or had only 1
menstrual period in the past 24 months.

If you have regular or no menstrual cycles, you will then have a urine or blood (less than 1
teaspoon) pregnancy test every week for the first 4 weeks, then every 4 weeks while taking
lenalidomide, again as soon as you have been taken off of lenalidomide therapy, and then 28
days after you have stopped taking lenalidomide.

If you have irregular menstrual cycles, you will have urine or blood (less than 1 teaspoon)
pregnancy test every week for the first 4 weeks, then every 2 weeks while taking
lenalidomide, again as soon as you have been taken off of lenalidomide therapy, and then at
14 days and 28 days after you have stopped taking lenalidomide.

Length of Study:

You will be on study treatment for about 1 year. You will be taken off study early if you
experience intolerable side effects or the disease gets worse.

If the doctor thinks you are benefiting, you may be able to continue taking the study
treatment. If you continue, you will follow the same schedule of dosing and study visit
schedule.

This is an investigational study. Lenalidomide and rituximab are FDA approved and
commercially available. Lenalidomide is approved for the treatment of multiple myeloma and
some myelodysplastic syndromes. Rituximab is approved for the treatment of chronic
lymphoproliferative disorders and non-Hodgkin's lymphoma. The combination of these drugs to
treat CLL and SLL is investigational.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
with active disease.

2. Patients must be age 18 or over at the signing of consent and must understand and
voluntarily sign an informed consent.

3. Prior treatment with purine analog based chemotherapy or chemoimmunotherapy.

4. ECOG/WHO performance status of 0-2.

5. Adequate renal function indicated by serum creatinine less or equal to 2 mg/dl.
Adequate hepatic function indicated as total bilirubin less or equal to 2 mg/dl and
ALT less or equal to two times the upper limit of normal.

6. Disease free of prior malignancies for 3 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
or breast. Patients with malignancies with indolent behavior such as prostate cancer
treated with radiation or surgery can be enrolled in the study as long as they have a
reasonable expectation to have been cured with the treatment modality received.

7. Females of childbearing potential (FCBP) must have a negative serum or urine
pregnancy test (sensitivity of at least 50 mIU/mL) 10-14 days prior to starting
lenalidomide. A female of childbearing potential is a sexually mature woman who: 1)
has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been
naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at
any time in the preceding 24 consecutive months).

8. Continued from Criteria #7. FCBP 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 talking lenalidomide. FCBP must also agree to ongoing
pregnancy testing.

9. Continued from Criteria #8: 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.

10. Men must agree not to father a child. They must agree to use a latex condom during
sexual contact with females of childbearing potential while participating in the
study and for at least 28 days following discontinuation from the study even if he
has undergone a vasectomy. They will be warned that sharing study drug is prohibited
and will be counseled about pregnancy precautions and potential risks of fetal
exposure. They must agree to abstain from donating blood, semen, or sperm during
study participation and for at least 28 days after discontinuation from the study.

11. Continued from Criteria #10: Counseling about the requirement for latex condom use
during sexual contact with females of childbearing potential and the potential risks
of fetal exposure must be conducted at a minimum of every 28 days. During counseling,
subjects must be reminded not to share study drug and to not donate blood, sperm, or
semen (during study participation and for 28 days following discontinuation from the
study).

Exclusion Criteria:

1. Known sensitivity to lenalidomide or other thalidomide derivatives or rituximab.

2. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).

3. Known positivity for HIV or active hepatitis (B or C).

4. Pregnant or breast feeding females.

5. History of tuberculosis treated within the last five years or recent exposure to
tuberculosis.

6. Any serious medical condition, laboratory abnormality, or psychiatric illness that
places the subject at unacceptable risk if he/she were to participate in the study.

7. Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus
(PE), in the six months prior to enrollment are not eligible for this study.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Patient Response

Outcome Time Frame:

Efficacy + toxicity evaluated first at completion of cycle 6 (28 day cycle) through 1 year

Safety Issue:

No

Principal Investigator

Alessandra Ferrajoli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2007-0208

NCT ID:

NCT00759603

Start Date:

September 2008

Completion Date:

December 2015

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Leukemia
  • CLL
  • Chronic Lymphocytic Leukemia
  • SLL
  • Small Lymphocytic Lymphoma
  • Lenalidomide
  • Revlimid
  • Rituximab
  • Rituxan
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

The University of Texas M.D. Anderson Cancer CenterHouston, Texas