Lenalidomide and AT-101 in Treating Patients With Relapsed B-Cell Chronic Lymphocytic Leukemia



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/21/2018
Start Date:July 9, 2015
End Date:June 2020

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A Phase I/II Clinical Trial of Lenalidomide in Combination With AT-101 for the Treatment of Relapsed B-Cell Chronic Lymphocytic Leukemia (B-CLL)

This phase I/II trial studies the side effects and best dose of lenalidomide when given
together with R-(-)-gossypol acetic acid and to see how well they work in treating patients
with B-cell chronic lymphocytic leukemia (B-CLL) that has returned after a period of
improvement (relapsed). Biological therapies, such as lenalidomide, may stimulate the immune
system to attack cancer cells. R-(-)-gossypol acetic acid may stop the growth of cancer cells
by blocking some of the enzymes needed for cell growth and causing the cells to die. Giving
lenalidomide with R-(-)-gossypol acetic acid may be an effective treatment for relapsed or
refractory B-CLL. - Funding Source - FDA OOPD

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of lenalidomide in combination with AT-101
(R-(-)-gossypol acetic acid). (Phase I) II. To assess the overall response rate of
lenalidomide in combination with AT-101. (Phase II)

SECONDARY OBJECTIVES:

I. To assess the overall response rates of lenalidomide in combination with AT-101 at 6
months and 12 months.

II. To evaluate time to progression (TTP) for the combination of lenalidomide + AT-101.

III. To evaluate the safety of this combination in patients with relapsed B-CLL.

TERTIARY OBJECTIVES:

I. To conduct correlative studies for further understanding of the mechanism of antitumor
activity of lenalidomide and lenalidomide + AT-101.

OUTLINE: This is a phase I dose-escalation study of lenalidomide followed by a phase II
study.

Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Beginning in course
3, patients also receive AT-101 PO twice daily (BID) on days 1-3. Treatment repeats every 28
days for up to 11 courses (49-56 days for course 12 or last course of treatment) in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then every 3
months for up to 2 years.

Inclusion Criteria:

- Understand and voluntarily sign an informed consent form

- Able to adhere to the study visit schedule and other protocol requirements

- Diagnosis of B-CLL, confirmed by flow cytometric analysis and as per the criteria
outlined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL)/Hallek
December 2008

- Any prior therapy for B-CLL must have been discontinued >= 28-days prior to
registration

- Patients must have absolute lymphocyte counts (ALC) of more than 5,000 cell/mm^3

- During phase I: all patients with relapsed disease will be eligible if they have
received at least 1 prior standard CLL therapy and no more than 4 prior therapies (one
of which must be a purine analog and/or an alkylating agent)

- During phase II: all patients with relapsed disease will be eligible if they have
received a minimum of 1 prior standard therapy and a maximum of 2 prior treatments
(one of which must be a purine analog and/or an alkylating agent) for B-CLL and have
developed relapse disease

- Note: patients who have refractory disease (defined as - progressive disease on
last treatment, or less than 6 months of clinical response to the last treatment)
will not be eligible

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at
registration

- Absolute neutrophil count >= 1500/mm^3

- Platelet count >= 30,000/mm^3

- Serum creatinine =< 1.5 x upper limit of normal (ULN)

- Total bilirubin =< 1.5 mg/dL or direct bilirubin =< 1.0 mg/dL for patients with
Gilberts syndrome

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2 x
ULN or =< 5 x ULN if hepatic disease is present

- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
test with a sensitivity of at least 50 mIU/mL 10-14 days prior to and again within 24
hours before starting 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

- 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)

- All study participants must be registered into the mandatory RevAssist program, and be
willing and able to comply with the requirements of RevAssist

- Patient must require treatment for symptomatic B-CLL as defined by the by the
IWCLL/Hallek, December 2008 criterion or as determined clinically necessary by the
treating physician

- Willing to provide blood and baseline bone marrow aspirate samples for correlative
research purposes

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form

- Pregnant or lactating females

- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study

- Use of any other experimental drug or therapy =< 28 days prior to registration

- Known hypersensitivity to thalidomide or lenalidomide

- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs

- Patients with of history of any other cancer (except nonmelanoma skin cancer or
carcinoma in-situ of the cervix, unless in complete remission and off therapy for that
disease for > 3 years)

- Patient with history of cardiac arrest within the past 6 months

- Patients with history of prior bowel resection, malabsorption syndrome, inflammatory
bowel disease, prior bowel obstruction (partial or complete), Crohn disease, or any
other disease significantly affecting the gastrointestinal tract

- Prior use of gossypol or AT-101
We found this trial at
2
sites
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: Asher A. Chanan-Khan
Phone: 855-776-0015
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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