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Lenalidomide and Ofatumumab in Previously Treated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL)

2014-08-27 03:18:22 | BioPortfolio

Summary

The goal of this clinical research study is to learn if the combination of lenalidomide and ofatumumab can help to control chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have already received therapy. The safety of this drug combination will also be studied.

The objective of this study is to evaluate efficacy and tolerability of the combination of ofatumumab and lenalidomide in patients with recurrent CLL. The primary end-point will be efficacy and an overall response rate of 40% or higher will be the target for this combination. The secondary endpoint is tolerance of the combination. Excessive toxicity will consist in a rate of grade 3 and 4 non-hematological toxicity in more than 50% of the patients.

Description

The Study Drugs:

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

Ofatumumab is designed to bind to the surface of a type of white blood cells called B-cells and destroy them. The cancer cells in B-CLL/SLL are B-cells.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:

- You will have a physical exam, including measurement of your height, weight, and vital signs (blood pressure, heart rate, temperature, and breathing rate).

- You will be asked how well you are able to perform the normal activities of daily living (performance status).

- You will asked what drugs you may be taking.

- Blood (about 1-2 teaspoons) will be drawn for routine tests.

- You will have a bone marrow aspiration and biopsy to check the status of the disease. To collect a bone marrow aspirate/biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.

- You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).

- If you are a woman who is able to become pregnant, you must have two negative blood (about 1 teaspoon) or urine pregnancy tests. One test must be within 10-14 days before starting lenalidomide, and prior to first administration of ofatumumab and the second test within 24 hours before lenalidomide is prescribed. You will also take part in counseling through the RevAssist® program.

The study doctor or your regular leukemia doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

Study Drug Administration:

Each cycle is 28 days.

If you are found to be eligible to take part in this study, you will receive ofatumumab by vein over 4 hours at the following times:

- On Days 1, 8, 15, and 22 of Cycle 1.

- On Day 1 of Cycles 2-6.

- On Day 1 of every even cycle beginning Cycle 8 (Cycles 8,10,12, and so on).

Beginning on Day 9 of Cycle 1, you will take lenalidomide by mouth every day.

Swallow lenalidomide capsules whole with a glass of 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 taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose). If you take more than the prescribed dose of lenalidomide you should seek emergency medical care if needed and contact study staff right away. Any unused lenalidomide should be returned as instructed through the RevAssist® program.

On Days 1-14 of Cycle 1, you will take allopurinol to help prevent side effects. You will take this by mouth with 1 glass of water 1 time a day. If the doctor thinks it is needed, you will continue to take allopurinol.

If the doctor thinks it is needed, you may take aspirin or low molecular weight heparin to help prevent blood clots.

If the doctor thinks it is needed, you may take medicine to help prevent return of hepatitis B infection.

You should drink at least 8-10 cups of water each day for the first 14 days of Cycle 1 ( this includes the 1 with medications).

Study Visits:

One (1) time a week for the first 5 weeks, then 1 time every 2 weeks (if the dose of lenalidomide has been changed), and then every 4 weeks, blood (about 2-3 teaspoons) will be drawn for routine tests.

On Day 28 of Cycles 3, 6, 12, 18, and 24:

- You will have a physical exam, including measurement of your vital signs.

- Your performance status will be recorded

- Urine will be collected for routine tests.

- You will have a bone marrow aspiration and biopsy to check the status of the disease.

If you continue past 24 cycles, once every 6-12 cycles:

- Blood (about 2-3 teaspoons) will be drawn for routine tests.

- If the doctor thinks it is needed, you will have a bone marrow biopsy and aspirate to check the status of the disease .

If the doctor thinks it is needed, extra blood (about 2-3 teaspoons) will be drawn for routine tests and at any time during the study.

If you have a type of hepatitis B called HBcAb, you are at risk of having hepatitis B infection during treatment with ofatumumab. Every 2 months, blood (about 1/2 teaspoon each time) will be drawn to check for hepatitis B infection.

Pregnancy Testing:

If you are a woman who is able to become pregnant, you will have blood (about 1 teaspoon) or urine pregnancy tests 1 time a week for the first 28 days of the study, then every 28 days while on study, when you stop the study, and at 28 days after off study.

If you are a woman who is able to become pregnant and your menstrual cycles are irregular, you will have blood (about 1 teaspoon) or urine pregnancy tests 1 time a week for the first 28 days, then every 14 days while on study, when you stop the study, and at 14 and 28 days after off study.

Length of Study:

You will be on study for about 2 years. You will be taken off study early if you have intolerable side effects or the disease gets worse.

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

Follow-Up:

About 6 months after you go off study, blood (about 1 teaspoon) will be drawn for routine tests. You will not need to come to M. D. Anderson for this blood draw, it can be performed by your local doctor.

The study staff will call you every 3 months from then on unless you begin a new treatment and ask you how you are doing. This phone call will take about 2-3 minutes.

After you are off study, if you have hepatitis B, blood (about 1/2 teaspoon each time) will be drawn every 2-3 months up to 6 months after the last dose of ofatumumab.

This is an investigational study. Lenalidomide is FDA approved for the treatment of multiple myeloma and some myelodysplastic syndromes. Ofatumumab is FDA approved and commercially available for the treatment of CLL. The combination of lenalidomide and ofatumumab to treat CLL or SLL is investigational.

Up to 36 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

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

Conditions

Chronic Lymphocytic Leukemia

Intervention

Lenalidomide, Ofatumumab

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:22-0400

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Medical and Biotech [MESH] Definitions

A chronic leukemia characterized by abnormal B-lymphocytes and often generalized lymphadenopathy. In patients presenting predominately with blood and bone marrow involvement it is called chronic lymphocytic leukemia (CLL); in those predominately with enlarged lymph nodes it is called small lymphocytic lymphoma. These terms represent spectrums of the same disease.

A chronic leukemia characterized by a large number of circulating prolymphocytes. It can arise spontaneously or as a consequence of transformation of CHRONIC LYMPHOCYTIC LEUKEMIA.

A lymphoid leukemia characterized by a profound LYMPHOCYTOSIS with or without LYMPHADENOPATHY, hepatosplenomegaly, frequently rapid progression, and short survival. It was formerly called T-cell chronic lymphocytic leukemia.

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A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.

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