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

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

Thank you

Trial Information

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

This is an open-label, single institute Phase I/II non-randomized study. Patients with
relapsed or refractory CLL (received at least one prior therapy for B-CLL) will be eligible
for this study. Phase I: Patients will receive a fixed dose of AT-101 (40mg orally twice
daily x 3 days) while the dose of lenalidomide will be escalated in subsequent patient
cohorts. Starting dose of lenalidomide will be 5mg/day and the dose will increase by 5mg/day
to a maximum of 20mg/day in 4 separate cohorts. Each patient cohort must have at least 3
patients. Dose limiting toxicity will be determined during the first combination
(Lenalidomide + AT-101) cycle (cycle 2). Both drugs will be given on a 21-day schedule where
lenalidomide will be given on day 1 through day 21 of all cycles and AT-101 will be given on
days 1, 2 and 3 or cycles 2-12. This 21 day period will constitute a treatment cycle.
Patients will receive a maximum of 12 cycles of treatment and during the first cycle, only
single agent lenalidomide will be given. AT-101 will be added starting day 1 of cycle #2.
Patients will be evaluated for response every two cycles and those patients who show some
degree of response (defined as CR, PR, or SD) will continue treatment. Those patients who
show disease progression at any time will be taken off the clinical protocol. Since the
study will be investigating the maximum tolerated dose (MTD) of lenalidomide in combination
with fixed dose of AT-101, the MTD will be established during the 2nd cycle of treatment
instead of the first (this cycle will actually be the first cycle of the combination
regimen). MTD will be determined during day 1 through day 21 of cycle 2. Once the MTD of the
combination is established, Phase II section of the study will then be open to accrual. All
patients in the phase I portion of the study must have completed at least 2 cycles of the
combination therapy prior to opening the Phase II portion of the study for accrual. This
will allow better characterization of the toxicity profile of the combination.

Inclusion Criteria:

- Understand and voluntarily sign an informed consent form.

- Age 18 years at the time of signing the 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 NCI working formulation.

- Any prior therapy for B-CLL must have been discontinued at least 28-days prior to
treatment in this study.

- Patients must have measurable disease either an absolute lymphocyte counts (ALC) of
more than 5,000 or measurable lymphadenopathy or organomegaly.

- Patients must have failed to respond to /or relapsed after at least 1 prior therapy
for CLL.

- ECOG performance status of <2 at study entry

Laboratory test results within these ranges:

- Absolute neutrophil count ≥1.5 x 109/L

- Platelet count ≥30 x 109/L

- Serum creatinine ≤1.5 x ULN.

- Total bilirubin ≤ 1.5 mg/dL

- AST (SGOT) and ALT (SGPT) ≤2 x ULN or ≤5 x ULN if hepatic disease is present.

- Females of childbearing potential (FCBP)T must have a negative serum or urine
pregnancy test with a sensitivity of at least 50mIU/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.

- All study participants must be registered into the mandatory RevAssist® program, and
be willing and able to comply with the requirements of RevAssist® -Patients must
require treatment for symptomatic B-cell as defined by the IWCLL/Hallek, December
2008 criterion or as determined clinically necessary by the treating physician

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 within 28 days of baseline.

- Known hypersensitivity to thalidomide or lenalidomide.

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

- Patients who have not been treated with any prior therapy for BCLL.

- 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 effecting the gastrointestinal tract.

- Prior use of gossypol or AT-101 or prior history of hypersensitivity reaction to
gossypol of AT -101.

Type of Study:


Study Design:

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

Outcome Measure:

Determine the maximum tolerated dose of lenalidomide in combination with AT-101

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Asher Chanan-Khan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:

RPCI I 101307



Start Date:

December 2009

Completion Date:

Related Keywords:

  • Lymphocytic Leukemia
  • Chronic B-Cell Leukemia
  • relapsed
  • refractory
  • Lymphocytic leukemia
  • Chronic B-Cell leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, B-Cell
  • Leukemia, Lymphoid



Roswell Park Cancer Institute Buffalo, New York  14263