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Phase I Trial of High Dose Lenalidomide in Patients With Refractory/Relapsed Acute Leukemia as a Bridge to Bone Marrow Transplant

Phase 1
18 Years
80 Years
Open (Enrolling)
Acute Leukemia

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Trial Information

Phase I Trial of High Dose Lenalidomide in Patients With Refractory/Relapsed Acute Leukemia as a Bridge to Bone Marrow Transplant

We hypothesize that lenalidomide in high doses can be used to decrease bone marrow blast
count in patients with relapsed or refractory acute myeloid leukemia in preparation for an
allogeneic stem cell transplant with acceptable toxicities that are no worse than current
cytotoxic chemotherapeutic agents. The known dose-limiting toxicity at 75 mg was excessive
fatigue in a previous phase I trial which in this study may be irrelevant as all study
participants will have an in-patient status.

Inclusion Criteria:

- Understand and voluntarily sign an informed consent form.

- Between 18 and 80 years of age at the time of signing the informed consent form.

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

- Non-M3 Acute Myeloid Leukemia with the presence of residual disease in the bone
marrow on day 14-28 post induction (or re-induction) chemotherapy. Day 14-28
residual disease is defined in this study as the presence of more than 10 % blasts in
the marrow, presence of between 5-10% blasts cells that are not in cluster in
hypocellular marrow is ambiguous and bone marrow biopsy should be repeated in 5-7

- Patient should have an already identified sibling, matched unrelated donor or cord
blood donor at the time of enrollment to this clinical trial.

- Eastern Cooperative Oncology Group (ECOG) performance status of equal or less than 3
at study entry (this patient population is typically admitted and is in the hospital)

- Laboratory test results within defined ranges

- Disease free of other malignancies beside the acute myeloid leukemia (AML) for
greater than or equal to 2 years with exception of currently treated basal cell,
squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.

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

- Females of childbearing potential (FCBP)must have a negative serum or urine pregnancy
test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 -
14 days and again within 24 hours prior to prescribing lenalidomide prescriptions
must be filled within 7 days as required by RevAssist) 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.

Exclusion Criteria:

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

- Pregnant or breast feeding females (Lactating females must agree not to breast feed
while taking lenalidomide).

- Patients younger than 50 years old, after first induction of chemotherapy, who are
able to safely tolerate re-induction therapy with high dose chemotherapy are not
eligible for this study.

- 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 14 days of baseline.

- Known hypersensitivity to thalidomide or lenalidomide (if applicable).

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

- Known sero-positive for active viral infection with human immunodeficiency virus,
hepatitis B virus or hepatitis C virus. Patients who are sero-positive because of
hepatitis B virus vaccine are eligible.

- Patients who are not able to swallow the lenalidomide capsule as a whole are excluded
from this study.

- Patients with impaired gastrointestinal absorption

- Symptomatic congestive heart failure

- Unstable angina pectoris or cardiac arrhythmia

- History of adrenal insufficiency

Type of Study:


Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (measured by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0)

Outcome Description:

All patients who receive the study drug will be followed closely and evaluated for toxicity.

Outcome Time Frame:

One Cycle (21 days)

Safety Issue:


Principal Investigator

Mehrdad Abedi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis


United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

August 2015

Related Keywords:

  • Acute Leukemia
  • Acute Leukemia
  • Bone Marrow Transplant
  • High Dose Lenalidomide
  • Leukemia
  • Acute Disease



University of California Comprehensive Cancer Center Sacramento, California  95817